List of Abbreviations
CT – computed tomography
MRI – magnetic resonance imaging
УДД – levels of evidence certainty
RCT – randomized controlled trial
УУР – levels of recommendation consensus
Terms and Definitions
Diplopia — seeing double of a single object.
Hypophthalmos – a lower than normal position of the eyeball within the orbit.
Enophthalmos – a more posterior (deeper) than normal position of the eyeball within the orbit.
Exophthalmos – a more prominent (anterior) than normal position of the eyeball within the orbit.
Hemosinus – accumulation of blood in the paranasal sinuses.
Isolated maxillofacial trauma – trauma involving a single injury within the maxillofacial region.
Multiple maxillofacial trauma – trauma involving multiple injuries within the maxillofacial region.
Multiple head trauma – injury to multiple head regions (maxillofacial region, ENT, organ of vision, or brain) resulting from one or more wounding projectiles. I suggest removing this, since injury to multiple head regions is already a polytrauma. It can be replaced with 'Combined maxillofacial trauma – simultaneous damage to the maxillofacial region by multiple damaging factors'
Polytrauma of the maxillofacial region — simultaneous injury to the maxillofacial region and other anatomical regions of the body (head, neck, abdomen, pelvis, spine, extremities).
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Orbital floor fracture – disruption of the integrity of the bones forming the orbital floor.
The orbit is a bony cavity containing the organ of vision, which consists of the eyeball and its accessory structures. It has the shape of a truncated four-sided pyramid with its base facing anteriorly and laterally.
The inferior wall of the orbit is formed by the orbital surface of the body of the maxilla, the zygomatic bone, and the orbital process of the perpendicular plate of the palatine bone. The surface area of the inferior orbital wall is approximately 6 cm2, and its thickness is about 0.5 mm.
The thinnest part of the orbital floor is the infraorbital groove, which crosses it approximately in half and continues anteriorly into the infraorbital canal. The posterior part of the inner half of the inferior wall is somewhat stronger. The thickest and, consequently, strongest area is the junction of the medial and inferior walls of the orbit, supported by the medial wall of the maxillary sinus. This area serves as a buttress, which is important to consider when restoring the integrity of the orbital bones and fixing supporting structures. The inferior wall has a characteristic S-shaped profile, which must be taken into account when modeling implants. The orbital process of the perpendicular plate of the palatine bone is the strongest region compared to the surrounding orbital surface of the maxilla; therefore, in fractures, it almost always remains undamaged and can be used as a landmark for the orbital apex. In addition, it is of great importance in the reconstruction of total defects of the inferior orbital wall, when the entire part of the orbital floor formed by the maxilla is destroyed and the only support point where the posterior edge of the implant can be placed is the orbital process of the perpendicular plate of the palatine bone. In such situations, the outer edges of the inferior wall, which extend onto the medial and lateral walls of the orbit, also remain intact and essentially serve as landmarks and buttresses.
In fractures of the nasoorbitoethmoidal and zygomaticomaxillary complexes, as well as Le Fort II and III maxillary fractures, injuries to the orbital floor are observed in 100% of cases. A separate group consists of so-called "blow-out", "blow-in", or isolated fractures, where trauma to the orbital region damages only the inferior wall—and less frequently the medial wall—while the remaining anatomical structures remain intact.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
There are two theories regarding the mechanism of an isolated "blow-out" fracture of the inferior orbital wall. According to the "hydraulic" theory, the traumatic force, whose surface area exceeds the size of the orbital entrance, deforms and displaces the eyeball into the orbit, thereby compressing its contents and sharply increasing intraorbital pressure. This leads to the redistribution of energy to the orbital walls and a fracture of its thin inferior wall.
The essence of the "mechanical" theory is that the primary mechanism of a "blow-out" fracture of the orbital floor is wave-like deformations transmitted from the inferior orbital rim.
Experimental studies have demonstrated that fractures caused by wave-like deformation are most often limited to the anterior half of the orbital floor, do not extend to the medial wall, and are not accompanied by soft tissue entrapment.
The hydraulic mechanism more frequently causes much more extensive fractures involving not only the entire inferior wall, but also the medial wall of the orbit, as well as soft tissue prolapse and interposition.
In most cases, the triggering mechanism for isolated fractures of the inferior orbital wall is the direct transmission of impact force from the orbital margin to the bones of the orbital floor or medial wall. Fractures typically involve the area of the infraorbital groove, reach the inferior orbital fissure, and are accompanied by soft tissue entrapment, while severe injuries to the eyeball are absent.
In the "hydraulic" mechanism of trauma, volumetric defects of the orbital floor and medial wall are formed, which are accompanied by severe injury to the eyeball.
1.3 Epidemiology of the Disease or Condition
In fractures of the nasoorbitoethmoidal and zygomaticomaxillary complexes, as well as middle and upper Le Fort maxillary fractures, injuries to the orbital floor are observed in 100% of cases. In terms of incidence, zygomaticomaxillary complex injuries account for 14.5% to 24%, and middle and upper maxillary fractures account for 3.3% to 9.2% of all facial skull bone fractures.
Approximately one-third of fractures (34.8%) are comminuted and trapdoor-like in nature. The remaining 65.2% of fractures are comminuted with small fragments [1,2,3].
1.4 Features of Coding the Disease or Condition
S02.3 Fracture of orbital floor
1.5 Classification of the disease or condition
- Isolated (blow-out type):
Blow-out With displacement of bone fragments out of the orbital cavity
Blow-in With displacement of bone fragments into the orbital cavity
- Accompanied by injuries to other bones of the midface
Depending on the presence of bone fragment displacement:
- with displacement;
- without displacement.
Depending on the fracture pattern:
Linear
Comminuted:
"Eggshell"-type comminuted (retained by the periosteum)
Comminuted, accompanied by bone defect formation.
Depending on orbital tissue entrapment:
Without formation of orbital soft tissue herniation
With formation of orbital soft tissue herniation
Depending on localization:
Within the bounds of the inferior orbital wall
Combined with injury to the medial orbital wall
Combined with injury to the lateral orbital wall
Combined with injuries to both medial and lateral orbital walls
Depending on the time elapsed since the injury:
- fresh (up to 14 days post-injury);
- old/delayed (from 14 to 28 days post-injury).
If more than 28 days have passed since the fracture, such a fracture does not belong to this group of diseases and is coded according to ICD-10 as T90.2 – Sequelae of skull and facial bone fractures.
1.6 Clinical presentation of the disease or condition
The main clinical manifestations of an orbital floor fracture include: pain, soft tissue edema in the periorbital region, subcutaneous emphysema, alteration of the eyeball position (eno- or hypophthalmus), restriction of mobility and pain upon eyeball movement, binocular diplopia, numbness in the innervation zone of the infraorbital nerve, nasal breathing difficulty on the affected side, and epistaxis (typically from the nasal passage on the side of the trauma).
In young children (under 7 years of age), fractures are rare due to the elasticity of the bone tissue and the small size of the maxillary sinus. The pediatric group more frequently presents with general symptoms such as vomiting and nausea due to entrapment of the inferior rectus muscle in the fracture zone. This reflex is caused by connections between the trigeminal and vagus nerves of the parasympathetic nervous system. This often mimics traumatic brain injury and concussion symptoms.
A specific feature of pediatric fractures is "white-eyed" fractures, where external signs of trauma such as edema and hematomas are absent.
Children more frequently experience pain with eye movement, diplopia, and restricted mobility, while extensive floor defects are less common. Features of pediatric fractures include "trapdoor" fractures, where the bone defect is small and the inferior rectus muscle is tightly fixed between the fracture edges, potentially leading to ischemia followed by necrosis of the muscle fibers. In such cases, early intervention within 3–7 days is recommended, as it improves the postoperative outcome.
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for establishing the disease or condition: the definitive diagnosis of an inferior orbital wall fracture is made based on radiological imaging methods, with computed tomography being the priority.
2.1 Complaints and Anamnesis
It is recommended to obtain an anamnestic history indicating the occurrence of trauma in all patients. It is recommended to elicit complaints of pain, soft tissue swelling, alteration of eyeball position, restriction of mobility and pain upon eye movement, double vision, sensation of facial skin numbness, nasal breathing difficulty, and history of nosebleed [3].
GCP CLEL 5Level of Evidence C (Level of Likelihood of Evidence - 5).
2.2 Physical Examination
It is recommended to initiate physical examination in all patients by determining physiological facial symmetry, assessing for edema, evaluating eyeball position, testing eyeball mobility and diplopia, determining skin sensitivity in the infraorbital regions, checking for subconjunctival and sub-scleral hematoma, and assessing nasal breathing difficulty on the affected side [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
It is recommended that all patients undergo an examination by a maxillofacial surgeon in order to establish the diagnosis of orbital wall injury [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: the maxillofacial surgeon establishes the diagnosis, determines the treatment plan, assesses the need for additional diagnostic methods and consultations with related specialists, and performs surgical treatment.
It is recommended that all patients undergo an ophthalmological examination to assess the state of the organ of vision [4]
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: Orbital floor fractures may be combined with eyeball injury, retinal hemorrhage, optic nerve entrapment or rupture, and ophthalmic artery thrombosis. The ophthalmological examination should include an assessment of the fundus and coordinatometry [5]
It is recommended that patients presenting with complaints of loss of consciousness, nausea, vomiting, dizziness, or with physical examination findings of nystagmus, anisocoria, sluggish pupillary light reflex, convergent or divergent strabismus, or upper eyelid ptosis undergo an evaluation by a neurologist or neurosurgeon to rule out traumatic brain injury [3].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: Ptosis, miosis or mydriasis, convergent or divergent strabismus, and absence of the pupillary light reflex may indicate damage to the cranial nerves III, IV, and VI. The combination of ophthalmoplegia, upper eyelid ptosis, mydriasis, and loss of corneal and eyelid skin sensitivity indicates superior orbital fissure syndrome (Rochon-Duvignaud syndrome) [6].
It is recommended in case of complaints regarding ENT organs, an examination by an otorhinolaryngologist in order to assess the condition of ENT organs [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: Orbital floor fractures may be associated with injuries to the nasoorbitoethmoidal complex.
It is recommended that patients undergo an evaluation by an anesthesiologist-resuscitologist prior to surgery to assess the anesthetic risk [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
2.3 Laboratory Diagnostics
Laboratory diagnostic tests are recommended for all patients with orbital floor fractures prior to surgery as part of the standard preoperative workup for elective surgery [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: Indications include a complete blood count (CBC), urinalysis, general clinical blood chemistry panel (mandatory determination of total protein, AST, ALT, total and free bilirubin, urea and/or creatinine, and blood glucose), coagulography (screening test for the hemostatic system), testing for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies, HIV-1 and HIV-2 antibodies (IgM, IgG), antibodies to Treponema pallidum, blood typing (ABO system), and Rhesus (Rh) factor determination
2.4 Instrumental Diagnostics
It is recommended to perform multispiral computed tomography (MSCT) of the orbit (A06.26.006) in all patients [7, 36, 37].
GCR CLEL 5Grade of Recommendation C (Level of Evidence - 5)
Comments: in the provision of specialized medical care, standard radiography (such as skull radiography, targeted radiography of the orbit, and other skull projections) cannot be considered the method of choice for diagnosing an orbital floor fracture. Cone-beam computed tomography or multispiral computed tomography, recommended with a resolution of at least 0.6 mm, provides complete information about the fracture. When head trauma occurs with suspected orbital floor fracture, MSCT of the brain and facial bones is recommended. This approach provides a comprehensive view of the midface skeleton bones, their relationship with the orbital soft tissues, including extraocular muscles, for diagnosis and surgical planning, while also ruling out intracranial pathology in traumatic brain injury. However, if CT is not available, routine radiographic imaging—such as skull, orbital, and paranasal sinus radiography—may be used to detect signs of a fracture and refer the patient to a specialized center.
2.5 Other Procedures
An orbital floor fracture combined with other craniomaxillofacial injuries can present with a variable clinical picture and may require additional diagnostic modalities depending on the clinical manifestations. No other specific diagnostic methods beyond those described above are indicated.
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Conservative Treatment
Conservative treatment is recommended for orbital floor fractures without displacement, or with minimal displacement that does not lead to aesthetic or functional impairments (changes in globe position and motility, diplopia, or visual acuity loss) [3, 6, 7, 8, 9]
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
In cases of minor displacement of orbital floor bone fragments, it is recommended to perform follow-up evaluations by a maxillofacial surgeon and an ophthalmologist for six months to detect signs of hypo- or enophthalmos and potential diplopia after the resolution of edema and scar formation [5].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: conservative management includes symptomatic therapy, avoidance of physical exertion and overheating for 2 months, analgesia, and the use of ATC group R01A nasal decongestants and other topical nasal preparations [10, 11] to improve maxillary sinus drainage, as well as systemic corticosteroids (ATC group H02A) to reduce edema, etc. [61]. Patients with minimal bone fragment displacement and no clinical symptoms require active surveillance to reassess symptoms (particularly globe position) after the edema subsides.
In accordance with the modern pain management concept, all patients with orbital floor fractures are recommended to receive analgesics based on the priority of assessing pain intensity, taking into account potential contraindications to commonly used drug classes—analgesics and non-steroidal anti-inflammatory and antirheumatic drugs (M01A) [46-50].
LoE AGoR 3Level of Evidence A (Level of Certainty of Evidence - 3)
Comments: various analgesics are used to reduce pain [46-51]
differential approach to the choice of analgesic drug:
- mild pain – #paracetamol** IV infusion, single dose – 0.5–1 g administered over 15 minutes, maximum daily dose – 4 g, maximum duration of administration 5–7 days. The drug is contraindicated in neonates under 1 month of age.
Subsequent dosing should be calculated based on age-specific dosing guidelines.
For oral formulations: Oral suspension 120 mg/5 ml is dosed in children aged 3 months to 12 years at a single dose of 10–15 mg/kg body weight. The maximum daily dose should not exceed 60 mg/kg body weight, administered in divided single doses of 10–15 mg/kg body weight over 24 hours. Do not give the child more than 4 doses in a 24-hour period;
Tablets 500 mg – contraindicated in children under 6 years of age; children aged 6 to 8 years: ½ tablet (250 mg) every 4–6 hours as needed, up to a maximum of 4 times daily; children aged 9 to 11 years: 1 tablet (500 mg) every 4–6 hours as needed, up to a maximum of 4 times daily; children aged 12 to 18 years: dosing regimen is identical to adults, 1–2 tablets (500–1000 mg) every 4–6 hours as needed. Maximum daily dose: 4000 mg (8 tablets) [46-51];
- moderate pain – combination pharmacotherapy is acceptable:
Paracetamol** combined with an NSAID (M01A), such as ibuprofen**, diclofenac**, ketorolac**, or ketoprofen**. Medication dosing must take into account age-related contraindications.
Opioids (N02AJ) combined with non-opioid analgesics. Medication dosing must take into account age-related contraindications [46-51];
Metamizole sodium is also acceptable as an alternative to non-steroidal anti-inflammatory and antirheumatic drugs. Medication dosing must take into account age-related contraindications [52-54].
- severe pain – opioids (N02A): morphine**, pethidine**, fentanyl**, tramadol** (dose titration must take into account age restrictions and contraindications) [46-50].
In selected cases, adult patients undergoing multimodal analgesia may be prescribed adjuvant medications to reduce postoperative pain intensity, decrease opioid tolerance, and lower the risk of developing and treating chronic pain syndromes. These include other general anesthetics (N01AX) or gabapentinoids (N02BF) such as gabapentin and pregabalin** (dose titration must take into account age-related contraindications).
Limited safety data exist regarding the use of gabapentinoids in children, primarily involving patients with neuropathic pain secondary to nerve-damaging trauma, cerebral palsy, and sciatic nerve injury [46-50, 55].
Opioids (N02AJ) are contraindicated in patients with traumatic brain injury.
3.2 Surgical Treatment
Surgical treatment is recommended for fractures of the inferior orbital wall accompanied by at least one of the following symptoms: globe position displacement greater than 2 mm (hypo-, enophthalmos), white-eyed syndrome, diplopia (except when present only in extreme gazes), restriction of extraocular motility, or MSCT findings of bone fragment displacement leading to orbital soft tissue herniation and entrapment of the inferior rectus muscle [6,7,8,12-15].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: In cases of equivocal computed tomography findings (no visible fracture on CT) and persistent restriction of extraocular motility over time, a traction test followed by orbitotomy and exploration of the inferior orbital wall is recommended.
- soft tissue edema within the orbit may mask the clinical presentation of globe displacement and persist for up to 2 months. Given evidence of bone fragment displacement on CT, redistribution of intraorbital tissues into the maxillary sinus (and the associated globe displacement) is inevitable; therefore, to prevent an acute injury from progressing to a more complex post-traumatic deformity, surgical treatment is indicated.
For orbital floor reconstruction, it is recommended to use transconjunctival, subciliary, subtarsal, or transantral surgical approaches [17,18].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: The transconjunctival approach may be combined with the retrocaruncular approach, and the subciliary approach with lateral extension and an extended glabellar approach, if simultaneous reconstruction of the orbital floor and other orbital walls is required [17,18]. The infraorbital approach is currently considered outdated and is not recommended due to the high risk of lower eyelid lymphedema. At the beginning and end of the surgical procedure, a traction test—a test for passive ocular motility—is performed.
During surgery for inferior orbital wall repair or fixation of repositioned bone fragments, it is recommended to use titanium plates (190580) or implants made of biocompatible materials of biological origin (bone autografts or allogeneic implants (105600)) or synthetic origin (281080) [17-19].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
In multiple craniomaxillofacial fractures utilizing a bicoronal approach through the cranial vault, when harvesting autografts for bone defect reconstruction is necessary, and harvesting such grafts (without intraoperative violation of the integrity of the inner cortical plate of the neurocranium) is not the sole indication for surgery on the cranial vault, it is recommended to use membranous bone autografts [20,21,22,23].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: when using autografts, membranous bone grafts are generally preferred; however, chondral autografts (autologous rib cartilage, autologous auricular cartilage, iliac crest) may also be used, though less favorably due to a high risk of resorption.
It is recommended to achieve rigid fixation of implants during orbital floor reconstruction, either using screws (190650) or by creating anatomical retention points [24, 25].
For the adult population – Level of Recommendations Placement B (Level of Evidence - 3)
For the pediatric population – Strength of recommendation C (Level of evidence - 5)
Comments: In slit-like and small orbital floor fractures with supportive ledges along the margins of the bone defect, reconstruction is feasible without rigid implant fixation, provided that the implant exceeds the dimensions of the bone defect.
An unfixed implant may become displaced, leading to secondary deformities and inflammatory complications.
It is recommended that surgical intervention be performed as early as possible. This applies particularly to fractures with entrapment of intraorbital tissues [26,27].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: the longer intraorbital tissues remain entrapped within the fracture line, the more pronounced their atrophy will be, which ultimately affects the position of the globe and necessitates measures aimed not merely at restoring normal anatomy, but at reducing the orbital volume (e.g., implant hypercorrection) to restore proper globe positioning.
At the same time, surgical treatment of patients with orbital floor fractures in severe polytrauma involving the maxillofacial region may be performed at a later stage, in accordance with clinical practice guidelines for the management of polytrauma with maxillofacial injuries.
It is not recommended to use ineffective, outdated treatment methods, specifically: attempts to support inferior orbital wall fragments using gauze packing, rubber balloons, or other similar techniques [1,3,7,28].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: these described techniques cannot be used in specialized medical care, fail to maintain bone fragments in the anatomically correct position, cause inflammatory complications such as sinusitis, and convert an acute injury into a more complex post-traumatic deformity.
It is recommended to use resorbable plates (190570) in children under 5 years of age [29,30,31]
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
Comments: by the age of 5 years, the orbit achieves approximately 80% of its final volume, permitting the use of non-resorbable implants from this age onward.
3.3 Prevention of Surgical Site Infections
It is recommended to perform perioperative antimicrobial prophylaxis (PAP) to prevent surgical site infections (SSIs) in all patients undergoing surgical treatment [38-45].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: The choice of PAP regimen and protocol is based on national and international guidelines for SSI prevention.
It is recommended that the systemic antibacterial drug dose used for PAP corresponds to the single therapeutic dose of the given drug to prevent infectious complications [38-45].
LoR ALoE 1Level of Recommendations Placement A (Level of Evidence - 1).
It is recommended to administer an additional intraoperative single dose of the systemic antibacterial drug if the duration of surgery exceeds 2 half-lives of the drug used for PAP [38-45, 56,57].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
It is recommended, in most cases, to administer a single dose of the systemic antibacterial drug; if prolonged prophylaxis is necessary, the drug should be discontinued no later than 24 hours postoperatively [38-45,56,57].
GCR ALeE 1Grade of Recommendation A (Level of Evidence - 1).
Comments: in cases of high risk for complications, antibiotic prophylaxis may be extended for 24-48 hours postoperatively. Extending antibiotic prophylaxis beyond the end of surgery does not increase its efficacy, but increases the risk of selecting antibiotic-resistant strains and complications, particularly Clostridioides difficile-associated diarrhea.
Table 3. Systemic antibacterial drugs for PAP in patients with orbital floor fractures
Type of surgical procedure | First-line drugs | Alternative drugs¹ | Administration time | Route of Administration | Notes |
|---|---|---|---|---|---|
Performance of operations with type I wounds ("clean wound"), where the development of postoperative complications is accompanied by a high risk of harm to the patient's health and life | |||||
1. Surgical treatment via an external approach without the risk of communication between the surgical wound and the oral cavity | Cefazolin²** or #Cefuroxime5**[62] | Vancomycin³** Or #Clindamycin4** [43, 56,57] | 30–60 min before incision | Intravenous infusion | AMP is administered once |
Performance of operations with type II wounds ("clean-contaminated wound") communicating with the upper respiratory tract and type III wounds ("contaminated wound") communicating with the digestive tract | |||||
1. Surgical treatment via an intraoral approach 2. Planned (risk of) communication of the surgical wound with the oral cavity 3. Surgical treatment of patients with an open fracture | Cefazolin²** + Metronidazole** or #Cefuroxime5**[62] + Metronidazole** or Amoxicillin + [Clavulanic acid]** | Vancomycin³** Or #Clindamycin4** [43, 56,-57] | 30–60 min before incision | Intravenous infusion | Perioperative antibiotic prophylaxis (PAP) is administered once, except for contaminated operations in which PAP antibiotics are administered for no more than 24 hours after surgery. |
¹ allergy to beta-lactam antibacterial drugs, penicillins, high risk of MRSA.
² contraindications include children under 1 month of age. The single dose for children aged 1 month to 18 years weighing less than 50 kg is calculated individually at 25 mg/kg per administration, not exceeding 1 g; for children over 50 kg, 1-2 g. For adults: body weight under 80 kg – 1 g; body weight between 80 kg and 130 kg – #2 g [38-45].
³ 120 minutes prior to incision
4 recommended for patients with beta-lactam antibiotic allergies and a low risk of MRSA colonization [56,57]
5 evidence regarding the efficacy of #cefuroxime for SSI prophylaxis in patients with orbital floor fractures is limited. This drug should be considered only as an alternative when cefazolin cannot be prescribed [62]
For type IV wounds ("infected wound") in cases of delayed presentation, pre-existing infection, purulent discharge, or non-viable tissue, antibiotic therapy is recommended [58-64].
LoR CLoE 4Level of Recommendations Placement C (Level of Evidence - 4).
Comments: Type IV wounds include old traumatic wounds with non-viable tissue, as well as postoperative wounds with pre-existing infection. It is implied that microorganisms capable of causing surgical site infections (SSIs) were present in the surgical area before the operation. When prescribing antimicrobials to patients with Type IV wounds ("infected"), it is necessary to follow the therapeutic doses specified in the instructions for medical use, and to take into account weight, age, and renal and hepatic function. Further selection of antibiotic therapy regimens should be determined by the severity of the infectious process and the results of microbiological studies.
Amoxicillin/clavulanic acid**. For intravenous administration in adults and adolescents over 12 years of age, 1 g (calculated as amoxicillin) 3 times a day is administered. The maximum daily dose is 6 g. The daily dose for children from 3 months to 12 years of age is 25 mg/kg every 6–8 hours (calculated as amoxicillin). The duration of treatment is up to 14 days.
Ampicillin/sulbactam** Adults and children over 12 years of age: for the treatment of moderate infections, the recommended dose is 1.5 g every 6 hours. For severe infections, 3 g every 6 hours. The maximum daily dose of sulbactam should not exceed 4 g, which corresponds to a total daily drug dose of 12 g. For children over 1 month and up to 12 years of age (or weighing less than 40 kg), the recommended dose is 150 mg/kg per day, divided into 3–4 administrations. In severe infections, the dose may be increased to 300 mg/kg/day.
Cefazolin** is contraindicated in children under 1 month of age. The average daily dose for children is calculated as 25–50 mg/kg/day; in severe cases, up to 100 mg/kg/day. The average duration of treatment is 7–10 days.
Metronidazole** In severe infections, the drug is administered as an intravenous infusion at a rate of 5 ml/min. The single dose for children under 12 years of age is 7.5 mg/kg; for children over 12 years of age, the single dose is 500 mg (100 ml of 0.5% solution).
Cefuroxime** for children, including infants, the daily dose is 30–100 mg/kg/day in 3–4 administrations; for newborns and infants under 3 months, 30 mg/kg/day in 2–3 injections.
Ceftriaxone** Adults and children over 12 years of age weighing more than 50 kg: 1–2 g once daily (every 24 hours). In severe cases or infections with pathogens of only moderate susceptibility to ceftriaxone, the daily dose may be increased to 4 g. Newborns, infants, and children under 12 years of age: when ceftriaxone is prescribed once daily, the following dosage regimens are recommended: − newborns (up to 14 days): 20–50 mg/kg of body weight once daily; the daily dose must not exceed 50 mg/kg of body weight; − newborns, infants, and young children (from 15 days to 12 years): 20–80 mg/kg of body weight once daily.
Vancomycin** The drug is administered only by continuous intravenous infusion. In adults and children over 12 years of age with normal renal function, the drug should be administered intravenously at 2 g per day (0.5 g every 6 hours or 1 g every 12 hours). Each dose should be administered at a rate of no more than 10 mg/min and over at least 60 minutes. The maximum single dose is 1 g, and the maximum daily dose is 2 g.
Children from 1 month to 12 years of age should be administered the drug IV at a dose of 10 mg/kg every 6 hours. Each dose should be administered over at least 60 min. The recommended daily dose is 40 mg/kg.
For newborns, the initial dose is 15 mg/kg, followed by 10 mg/kg every 12 hours during the 1st week of life. Starting from the 2nd week of life, every 8 hours until 1 month of age. Each dose should be administered over at least 60 minutes. When prescribing to newborns, monitoring serum vancomycin** concentrations is advisable. The concentration of the prepared vancomycin** solution should not exceed 2.5–5 mg/ml. The maximum single dose for newborns is 15 mg/kg of body weight. The daily dose for a child must not exceed the adult daily dose (2 g).
Clindamycin** Dosing according to the manufacturer's recommendations: Adults: The usual daily dose is 2400–2700 mg per day, divided into 2, 3, or 4 equal doses. For infections caused by more susceptible pathogens: 1200–1800 mg/day, divided into 3 or 4 equal doses. Maximum daily dose − 4800 mg. For children aged 3 to 18 years – 20–40 mg/kg/day, divided into 3–4 equal doses administered as an intravenous infusion over 10–60 minutes. The drug should not be administered via rapid intravenous push [58-60].
3.4 Other treatment
No other specific treatment is provided for patients with the described pathology.
4. Medical Rehabilitation and Sanatorium-Resort Treatment
All patients who have undergone surgical treatment are recommended to undergo rehabilitation measures aimed at the complete social and physical recovery of the patient [3, 32].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: regular patient monitoring makes it possible to control the quality of treatment throughout the entire rehabilitation period. Specific rehabilitation for the described pathologies is not provided; however, to provide comprehensive care and ensure complete rehabilitation of patients with orbital floor fractures, physical therapy, eye exercises, and other rehabilitation measures may be used depending on specific clinical symptoms. These rehabilitation measures should be considered in the relevant clinical guidelines.
5. Prevention and Dispensary Observation
5.4 Prevention
If there is a history of trauma and clinical manifestations of an orbital floor fracture, a consultation with a maxillofacial surgeon is recommended to determine the management and treatment strategy in order to provide timely medical care and prevent post-traumatic deformities (see Diagnostics section) [3].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
Comments: there is no specific prophylaxis for the described pathology.
5.5 Follow-up monitoring
It is recommended to establish follow-up care by a maxillofacial surgeon, ophthalmologist (in case of visual organ damage or extraocular movement disorders), otolaryngologist (if inflammatory complications of the maxillary sinuses are suspected), and physical therapist if accelerated postoperative rehabilitation is necessary [3, 33].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
To prevent inflammatory complications involving the maxillary sinuses, it is recommended to avoid hypothermia, overheating, saunas, swimming pools, and swimming in open bodies of water for the first 2 months after trauma or surgery [3, 34].
LoR CGoE 5Level of Recommendation C (Grade of Evidence - 5)
If secondary deformity is suspected, or if the patient's local, neurological, ophthalmological, or other status deteriorates, it is recommended to perform computed tomography of the orbits (A06.26.006), magnetic resonance imaging of the facial skull (A05.03.004), and other examinations based on the clinical picture [35].
GCR CLEL 4Grade of Recommendation C (Level of Evidence - 4)
6. Organization of Medical Care
Indications for hospital admission to a medical organization:
The necessity of performing instrumental diagnostic methods under anesthesia (applies to children).
The necessity of surgical intervention to repair the orbital floor fracture.
Indications for discharging the patient from the hospital:
Performance of scheduled diagnostic examinations.
Restoration of the anatomical integrity of the orbital walls.
No signs of postoperative complications.
7. Additional Information
In fractures with tissue entrapment, surgical treatment should be performed as early as possible, within the first few days following the trauma. Delayed interventions in this situation negatively affect treatment outcomes and prognosis.
Non-compliance by the patient with oral hygiene, myogymnastic exercises, and other medical prescriptions in the postoperative period adversely affects the wound process and leads to the development of inflammatory complications.
Criteria for Evaluating the Quality of Medical Care
Table 10. Quality of medical care assessment criteria.
№ | Criteria for evaluating the quality of medical care | Performance evaluation |
|---|---|---|
1 | A complete set of diagnostic measures was performed, during which the diagnosis of orbital floor fracture was established. | Yes/no |
2 | A complete set of measures aimed at preventing inflammatory complications was performed. | Yes/no |
3 | Surgical intervention was performed according to indications, during which the clinical manifestations of the fracture were eliminated. | Yes/no |
References
Show references
Kirkland N. Orbital Trauma / Kirkland N. Lozada, Patrick W. Cleveland, Jesse E. Smith // Semin Plast Surg. – 2019. - N. 33(2). – P.106–113.
Cohen L.M. Isolated Orbital Floor Fracture Management: A Survey and Comparison of American Oculofacial and Facial Plastic Surgeon Preferences / Liza M. Cohen, David A. Shaye, Michael K. Yoon // Craniomaxillofac Trauma Reconstr. – 2019. – N. 12(2) – P.112–121.
Belchenko V.A. Craniofacial Surgery / Belchenko Viktor Alekseevich. – M.: Medical Information Agency, 2006. – 430 p.
Politis C. Association of Midfacial Fractures with Ophthalmic Injury / Constantinus Politis, Alexandra Kluyskens, TitiaanDormaar // Craniomaxillofac Trauma Reconstr. – 2017. – Vol. 10(2). - P.99–105.
Scolozzi P. Reflections on a patient-centered approach to treatment of blow-out fractures: Why the wisdom of the pastmust guide our decision-making. J Plast Reconstr Aesthet Surg 2022;75(7):2268-2276. doi: 10.1016/j.bjps.2022.04.034.
Pankratov, A.S., Ushakov, R.V., Korkin, V.V. First aid for patients with maxillofacial injuries: Textbook. Moscow: FGBOU DPO RMANPO, 2017. – 89 p.
Belchenko V.A. 30-year experience in treating patients with orbital floor fractures / Belchenko V.A., Rybalchenko G.N. // Moskovskaya Meditsina. - 2019. - No. 6 (34). - P. 23.
Grob S. Orbital Fracture Repair / Seanna Grob, Marc Yonkers, Jeremiah Tao // Semin Plast Surg. – 2017. - N. 31(1). - P.31–39.
Mundinge G.S. Antibiotics and Facial Fractures: Evidence-Based Recommendations Compared with Experience-Based Practice / Gerhard S. Mundinger, Daniel E. Borsuk, Zachary Okhah, Michael R. Christy, Branko Bojovic, Amir H. Dorafshar, Eduardo D. Rodriguez // Craniomaxillofac Trauma Reconstr. – 2015. N 8(1). - P.64–78
Sadovsky, I. M. Features of surgical treatment tactics for post-traumatic midface deformities. // Thesis for the degree of Candidate of Medical Sciences: 14.00.27 / I. M. Sadovsky; Moscow, 2005. – 34 p.
Manson P.N. Facial fractures. // Plastic surgery. 2006. - P. 77-381.
Yamanaka Y. Impact of surgical timing of postoperative ocular motility in orbital blowout fractures / Yukito Yamanaka, Akihide Watanabe, Chie Sotozono, Shigeru Kinoshita // Br J Ophthalmol. – 2018. - N. 102(3). - P.398–403.
Su Y. Diplopia of Pediatric Orbital Blowout Fractures: A Retrospective Study of 83 Patients Classified by Age Groups / Yun Su, Qin Shen, Ming Lin, Xianqun // Fan Medicine. – 2015. - N. 94(4). - P.477.
Burnstine M A Clinical recommendations for repair of isolated orbital floor fractures: an evidence-based analysis Ophthalmology 2002 109(7)1207–1210., discussion 1210–1211, quiz 1212–1213
Belchenko V.A. Clinical and anatomical rationale for the use of transantral surgical access in orbital floor fractures. Part I / Belchenko V.A., Rybalchenko G.N., Glyazer I.S. (Baranyuk) // Stomatologiya. – 2014. – No. 93(2). – P. 27-30.
Belchenko V.A. Clinical and anatomical rationale for the use of transantral surgical access in orbital floor fractures. Part II / Belchenko V.A., Rybalchenko G.N., Glyazer I.S. (Baranyuk) // Stomatologiya. – 2014. – No. 93(3). – P. 23-27.
CMF Trauma: Midface: All approaches // AO Foundation Surgery Reference [Electronic resource] URL: https://surgeryreference.aofoundation.org/cmf/trauma (access date 05.12.2024)
Pankratov A.S., Gociridze Z.P., Kondrat A.V.,Karalkin A.V. Repair of orbital floor fractures via the transantral approach with osteosynthesis plate. Oral and Maxillofacial Surgery.2020; 24:309–31 doi: 10.1007/s10006-020-00850-x
Balaji S.M.Surgical Correction of Diplopia in Orbital Fracture: Influence of Material and Design / S. M. Balaji, Preetha Balaji // Ann Maxillofac Surg. – 2019. - N 9(1). - P.129–134.
Grusha Ya.O. Correction of post-traumatic orbital defects using bone autografts / Ya.O. Grusha, A.S. Karayan, G.I. Korobkov, S.S. Danilov // Stomatologiya. – 2019. – No. 98(1). – P. 38-44.
Karayan A.S. [Clinical and roentgenological evaluation of various methods for restoring orbital floor defects in post-traumatic midface deformations] / A.S. Karayan // Vestnik Rentgenologii i Radiologii. – 2006. – No. 4. – P. 4-7. (In Russ.)
Karayan A.S. [Method for correcting post-traumatic enophthalmos and hypophthalmos] / A.S. Karayan, E.S. Kudinova, D.A. Bronshtein, S.A. Zaslavsky // Stomatologiya dlya Vseh. – 2008. – No. 2. – P. 48-50. (In Russ.)
Bande C.R. Reconstruction of Orbital Floor Fractures with Autogenous Bone Graft Application from Anterior Wall of Maxillary Sinus: A Retrospective Study / Chandrashekhar R. Bande, Surendra Daware, Pravin Lambade, Bhaskar Patle // J Maxillofac Oral Surg. – 2015. N. 14(3) – P.605–610.
Xu Q.H. Analysis of the effect of repair materials for orbital blowout fracture on complications / Qi-Hua Xu, Jin-Hai Yu, Yao-Hua Wang, An-An Wang, Hong-Fei Liao // Int J Ophthalmol. -2019. – N. 12(11) – P.1746–1750.
Joshi S., Kassira W., Thaller S.R. Overview of pediatric orbital fractures // Journal of Craniofacial Surgery. – 2011. – Vol. 22. – No. 4. – P. 1330-1332.
Lee S.C. Prognostic Factors of Orbital Fractures with Muscle Incarceration /
Seung Chan Lee, Seung-Ha Park, Seung-Kyu Han, Eul-Sik Yoon, Eun-Sang Dhong, Sung-Ho Jung, Hi-Jin You, Deok-Woo Kim // Arch Plast Surg. – 2017. – N. 44(5). – P.407–412.
Anehosur V. Endoscopic Assisted Combined Transantral and Subciliary Approach in Treatment of Orbital Floor Fracture: A Case Report / Venkatesh Anehosur, K. Harish // J Maxillofac Oral Surg. – 2018. – Vol. 17(2). – P.193–196.
Nasir S.A. Predictors of enophthalmos among adult patients with pure orbital blowout fractures / Suraya Ahmad Nasir, Roszalina Ramli, Nazimi Abd Jabar // PLoS One. – 2018. – N. 13(10). – P. 25-28.
Jang H.U. Biodegradable implants for orbital wall fracture reconstruction / Hyeon Uk Jang, So Young Kim // Arch Craniofac Surg. – 2020. – N. 21(2) – P.99–105.
Alkhalil M. Orbital reconstruction with a partially absorbable mesh (monofilament polypropylene fibre and monofilament poliglecaprone-25): Our experience with 34 patients / Moustafa Alkhalil, J. Joshi Otero // Saudi J Ophthalmol. – 2016. – N. 30(3) – P.169–174.
Valente L. Orbital Fractures in Childhood / RiccadoTieghi, Giovanni Elia, Manlio Galiè // Ann Maxillofac Surg. – 2019. - N 9(2). P.403–406.
Yoo Y.J. Pediatric orbital wall fractures: Prognostic factors of diplopia and ocular motility limitation / Yung Ju Yoo, Hee Kyung Yang, Namju Kim, Jeong-Min Hwang // PLoS One. – 2017. – Vol. 12(11). – P.23-25.
Yim C.K. Analysis of Early Outcomes After Surgical Repair of Orbital Floor Fractures /
Cindi K. Yim, Rocco Ferrandino, James Chelnis, I. Michael Leitman // Facial Plast Surg. – 2018. – N. 20(2). – P.173–175.
Shew M. Surgical Treatment of Orbital Blowout Fractures: Complications and Postoperative Care Patterns / Matthew Shew, Michael P. Carlisle, Guanning Nina Lu, Clinton Humphrey, J. David Kriet // Craniomaxillofac Trauma Reconstr. – 2016. – Vol. 9(4). - P.299–304.
Carpenter D. The Role of Postoperative Imaging after Orbital Floor Fracture Repair /
David Carpenter, Ronnie Shammas, Adam Honeybrook, C. Scott Brown, Nikita Chapurin, Charles R. Woodard // Craniomaxillofacial Trauma Reconstr. – 2018. N. 11(2). - P. 96–101.
Chang, E. W., &Manolidis, S. (2005). Orbital Floor Fracture Management. Facial Plastic Surgery, 21(03), 207–213. doi:10.1055/s-2005-922861
Chawla H. et al. Sensitivity and specificity of CT scan in revealing skull fracture in medico-legal head injury victims // The Australasian Medical Journal. – 2015. – Vol. 8. – No. 7. – P. 235.
Aslanov B.I. et al. [Principles of organizing perioperative antimicrobial prophylaxis in healthcare facilities]. – 2014. [Electronic resource: https://library.mededtech.ru/docs] available at: https://library.mededtech.ru/rest/documents/2014_9_PAP_new/#paragraph_eeu7oi (In Russ.)
Yakovlev S.V., Briko N.I., Sidorenko S.V., Protsenko D.N. SKAT program (Antimicrobial Therapy Control Strategy) in inpatient medical care: Russian clinical guidelines / Moscow: Pero Publishing House, 2018. – 156 p. (In Russ.)
Bratzler, D. W. et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery // Surgical infections. – 2013. – Vol. 14. – No. 1. – P. 73-156.
Hussain Z., Curtain C., Mirkazemi C., Gadd K., Peterson G.M., Zaidi S.T.R. Prophylactic Cefazolin Dosing and Surgical Site Infections: Does the Dose Matter in Obese Patients? Obes Surg. 2019 Jan;29(1):159-165. doi: 10.1007/s11695-018-3497-0.
Milic T., Raidoo, P., Gebauer, D. Antibiotic prophylaxis in oral and maxillofacial surgery: a systematic review. British Journal of Oral and Maxillofacial Surgery.-2020.-doi:10.1016/j.bjoms.2020.09.020
Langerman A, Thisted R, Hohmann S, Howell M. Antibiotic and Duration of Perioperative Prophylaxis Predicts Surgical Site Infection in Head and Neck Surgery. Otolaryngol Head Neck Surg. 2016 Jun;154(6):1054-63. doi: 10.1177/0194599816634303. Epub 2016 Mar 1. PMID: 26932957.
Mottini M., Wolf R., Soong P.L., Lieger O., Nakahara K., Schaller B. The role of postoperative antibiotics in facial fractures: Comparing the efficacy of a 1-day versus a prolonged regimen. J. Trauma Acute Care Surg. 2014;76:720–724. doi: 10.1097/TA.0000000000000123.
Lazzarini L, Brunello M, Padula E, de Lalla F. Prophylaxis with cefazolin plus clindamycin in clean-contaminated maxillofacial surgery. J Oral Maxillofac Surg. 2004 May;62(5):567-70. doi: 10.1016/j.joms.2003.12.004. PMID: 15122561
Ovechkin, A.M. et al. Postoperative pain management. Clinical guidelines // Annals of Critical Care named after A.I. Saltanov. – 2019. – No. 4. – P. 9-33. DOI: 10.21320/1818-474X-2019-4-9-33
Volchkov, V.A., Kovalev, S.V., Kubynin, A.N. Modern aspects of postoperative analgesia (literature review) // Bulletin of Saint Petersburg University. Series 11. Medicine. – 2018. – Vol. 13. – No. 3.
Verghese ST, Hannallah RS. Acute pain management in children. J Pain Res. 2010 Jul 15;3:105-23. doi: 10.2147/jpr.s4554. PMID: 21197314; PMCID: PMC3004641.
Wilson-Smith EM. Procedural Pain Management in Neonates, Infants and Children. Rev Pain. 2011 Sep;5(3):4-12. doi: 10.1177/204946371100500303. PMID: 26526331; PMCID: PMC4590075.
Hall RW, Anand KJ. Pain management in newborns. Clin Perinatol. 2014 Dec;41(4):895-924. doi: 10.1016/j.clp.2014.08.010. Epub 2014 Oct 7. PMID: 25459780; PMCID: PMC4254489.
Ziesenitz, V.C., Welzel, T., van Dyk, M. et al. Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years. Pediatr Drugs 24, 603–655 (2022). https://doi.org/10.1007/s40272-022-00514-1
Sümpelmann R, Fieler M, Eich C, Becke K, Badelt G, Leimkühler K, Dennhardt N. Metamizole for Postoperative Pain Therapy in Infants Younger than 1 Year. Eur J Pediatr Surg. 2017 Jun;27(3):269-273. doi: 10.1055/s-0036-1587332. Epub 2016 Sep 5. PMID: 27595441.
Konijnenbelt-Peters J, van der Heijden C, Ekhart C, Bos J, Bruhn J, Kramers C. Metamizole (Dipyrone) as an Alternative Agent in Postoperative Analgesia in Patients with Contraindications for Nonsteroidal Anti-Inflammatory Drugs. Pain Pract. 2017 Mar;17(3):402-408. doi: 10.1111/papr.12467. Epub 2016 Jun 27. PMID: 27346584.
De Leeuw, T. G., Dirckx, M., Gonzalez Candel, A., Scoones, G. P., Huygen, F. J. P. M., & de Wildt, S. N. (2018). The use of dipyrone (metamizol) as an analgesic in children: what is the evidence? A review. Pediatric Anesthesia, 28(3), 309–309. doi:10.1111/pan.13341
Akkurt HE, Gümüş H, Göksu H, Odabaşı ÖF, Yılmaz H. Gabapentin Treatment for Neuropathic Pain in a Child with Sciatic Nerve Injury. Case Rep Med. 2015;2015:873157. doi: 10.1155/2015/873157. Epub 2015 Aug 4. PMID: 26346828; PMCID: PMC4539467.
Lindeboom JA, Baas EM, Kroon FH. Prophylactic single-dose administration of 600 mg clindamycin versus 4-time administration of 600 mg clindamycin in orthognathic surgery: A prospective randomized study in bilateral mandibular sagittal ramus osteotomies. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Feb;95(2):145-9. doi: 10.1067/moe.2003.54. PMID: 12582352.
Reiss B, Rajjoub L, Mansour T, Chen T, Mumtaz A. Antibiotic Prophylaxis in Orbital Fractures. Open Ophthalmol J. 2017 Jan 31;11:11-16. doi: 10.2174/1874364101711010011. PMID: 28400887; PMCID: PMC5362967.
Chunduri NS, Madasu K, Goteki VR, Karpe T, Reddy H. Evaluation of bacterial spectrum of orofacial infections and their antibiotic susceptibility. Ann Maxillofac Surg. 2012 Jan;2(1):46-50. doi: 10.4103/2231-0746.95318. PMID: 23482901; PMCID: PMC3591083.
Chang CH, Lai YH, Wang HZ, Su MY, Chang CW, Peng CF. Antibiotic treatment of orbital cellulitis: an analysis of pathogenic bacteria and bacterial susceptibility. J Ocul Pharmacol Ther. 2000 Feb;16(1):75-9. doi: 10.1089/jop.2000.16.75. PMID: 10673134.
Lee S, Yen MT. Management of preseptal and orbital cellulitis. Saudi J Ophthalmol. 2011 Jan;25(1):21-9. doi: 10.1016/j.sjopt.2010.10.004. Epub 2010 Dec 10. PMID: 23960899; PMCID: PMC3729811.
Haapanen, A., Thorén, H., Apajalahti, S., Suominen, A. L., & Snäll, J. (2018). Neurosensory recovery after trauma to the orbital floor: a prospective trial with dexamethasone. British Journal of Oral and Maxillofacial Surgery. doi:10.1016/j.bjoms.2018.08.017
Sommerstein R. et al. Timing of cefuroxime surgical antimicrobial prophylaxis and its association with surgical site infections // JAMA Network Open. – 2023. – Vol. 6. – No. 6. – P. e2317370-e2317370.
Appendix A1. Working Group Composition
Kulakov, A. A. – Academician of the Russian Academy of Sciences, MD, Professor, President of the Association of Maxillofacial Surgery Specialists LLC.
Braylovskaya T.V. – MD, Professor, Executive Secretary of the LLC "Association of Maxillofacial Surgeons".
Bayrikov, I. M. – Corresponding Member of the Russian Academy of Sciences, MD, Professor, Member of the Association of Maxillofacial Surgery Specialists LLC.
Ivanov, S. Yu. – Corresponding Member of the Russian Academy of Sciences, MD, Professor, Board Member of the Association of Maxillofacial Surgery Specialists LLC.
Belchenko V. A. – MD, Professor, Board Member of the Association of Maxillofacial Surgeons.
Drobyshev A.Yu. – MD, Professor, Vice-President of the LLC "Association of Maxillofacial Surgeons".
Yaremenko A. I. – MD, Professor, Vice-President of the Association of Maxillofacial Surgeons.
Malinovskaya N.A. – PhD in Medical Sciences, Associate Professor, Board Member of the St. Petersburg Branch of the LLC "Russian Ophthalmological Society".
Pankratov A.S. – MD, Professor, Member of the LLC "Association of Maxillofacial Surgeons".
Roginsky V.V. – MD, Professor, Member of the LLC "Association of Maxillofacial Surgeons".
Topolnitsky O.Z. – MD, Professor, Board Member of the Association of Maxillofacial Surgeons.
Durnovo E.A. – MD, Professor, Board Member of the Association of Maxillofacial Surgeons.
Epifanov S.A. – MD, Associate Professor, Member of the LLC "Association of Maxillofacial Surgeons".
Glazer I.S. – Member of the LLC "Association of Maxillofacial Surgeons".
Bagnenko A.S. – Candidate of Medical Sciences, Associate Professor, Member of the "Association of Specialists in Maxillofacial Surgery".
Baranov, I.V. – PhD in Medical Sciences, Member of the LLC "Association of Specialists in Maxillofacial Surgery".
There is no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
Maxillofacial surgeons
Ophthalmologists
Otolaryngologists
Neurosurgeons
Table 1. Scale for assessing levels of evidence (LE) for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | Only justification of mechanism of action or expert opinion is available |
Table 2. Scale for assessing levels of evidence (LE) for prevention, treatment and rehabilitation methods (preventive, therapeutic, rehabilitation interventions)
LoE | Definition |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | Only justification of the mechanism of action of the intervention (preclinical studies) or expert opinion is available |
Table 3. Scale for assessing grades of recommendation (GR) for prevention, diagnosis, treatment and rehabilitation methods (preventive, diagnostic, therapeutic, rehabilitation interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of adequate quality evidence (all considered efficacy criteria (outcomes) are unimportant, all studies are of low methodological quality, and their conclusions on the outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data regarding the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
"Order on the Provision of Medical Care in the Field of 'Maxillofacial Surgery'", approved by the Ministry of Health of the Russian Federation on June 14, 2019, No. 422n (registered by the Ministry of Justice of the Russian Federation on August 30, 2019, registration No. 55783).
Appendix B. Physician Action Algorithms
In fractures without bone fragment displacement and with normal eye mobility: perform a traction test under anesthesia. If the traction test is positive: orbitotomy, revision of the orbital floor.
Appendix C. Patient Information
The main clinical manifestations of an orbital floor fracture with displacement include: altered position of the eyeball, diplopia, and restricted eye mobility. None of these symptoms resolve spontaneously; on the contrary, the symptoms progress over time following the trauma. Treatment of orbital floor fractures with displacement is possible only through surgical intervention. During surgery, intraorbital tissues are returned to their anatomically correct position, the integrity of the orbital floor is restored via defect plasty with an implant using an orbital approach, or via reposition and fixation of bone fragments with an implant through the maxillary sinus. The choice of surgical method is individual for each specific case and depends on the nature of the fracture and the degree of involvement of adjacent anatomical structures. Timely surgery allows for the complete correction and prevention of both functional and aesthetic impairments. To prevent inflammatory complications from the maxillary sinuses, it is recommended to avoid hypothermia, overheating, saunas, swimming pools, and swimming in open water bodies for a period of 2 months after trauma or surgery. After this period, the patient has no restrictions related to the sustained trauma and treatment received.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable