List of Abbreviations
TM — tympanic membrane
EAC — external auditory canal
SET — superficial ear trauma
SEZ — superficial ear zone
TRTM — traumatic rupture of the tympanic membrane
Terms and Definitions
Superficial ear zone (SEZ) is the area including the auricle, the fibrocartilaginous part of the external auditory canal, and the external soft tissues of the mastoid region [1].
Superficial ear trauma is an injury resulting from mechanical impact (blow, contusion, animal bite, wound) localized in the superficial ear zone.
Traumatic rupture of the tympanic membrane (TRTM) is a disruption of the integrity of the tympanic membrane caused by external factors.
Ear barotrauma is damage to the structures of the middle and inner ear resulting from a sudden ambient pressure drop in the external auditory canal or tympanic cavity.
Acoustico-barotrauma is damage to the structures of the middle and inner ear resulting from the simultaneous impact of a sudden ambient pressure drop and high-intensity sound.
Level of evidence, LoE – ranking of research designs based primarily on their internal validity.
Note 1: this method is used to determine the persuasiveness of a study.
Note 2: various hierarchies of evidence are used to assess health technologies.
Level of clinical evidence (LCE) – the degree of certainty in the validity of the intervention's effect and in the fact that following the recommendations will bring more benefit than harm in a specific clinical situation.
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
Superficial ear zone is the area including the auricle, the fibrocartilaginous part of the external auditory canal, and the external soft tissues of the mastoid region.
Superficial ear injury is an injury resulting from mechanical impact (blow, contusion, bite, wound) localized in the superficial area of the ear.
Ear contusion is a mechanical damage to soft tissues localized in the superficial area of the ear, not accompanied by a visible breach of their anatomical integrity.
Othematoma is an accumulation of blood between the cartilage and perichondrium of the auricle resulting from mechanical trauma to this area.
Post-traumatic defect of the auricle is a partial breach of the integrity of the soft tissues of the auricle or its complete absence (amputation) following traumatic impact.
Perichondritis of the auricle is acute inflammation of the perichondrium that extends to the skin of the auricle and the fibrocartilaginous part of the external auditory canal without involving the earlobe.
Post-traumatic stenosis of the external auditory canal is a narrowing of the external auditory canal along its length following traumatic impact.
Acoustic barotrauma is damage to the structures of the middle and inner ear resulting from the simultaneous impact of a sudden ambient pressure drop and high-intensity sound.
Ear barotrauma is damage to the structures of the middle and inner ear resulting from a sudden drop in ambient pressure in the external auditory canal or tympanic cavity.
Traumatic rupture of the tympanic membrane is a breach of the integrity of the tympanic membrane resulting from external causes.
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
Superficial ear injury occurs as a result of a blow, contusion, bite, or wound (stab, cut, lacerated, gunshot) of the superficial area of the ear [2–5]. Such injuries may lead either to the loss of the organ or to its significant disfigurement with partial loss of auditory function [3].
Ear contusion is characterized by closed mechanical damage to soft tissues localized in the superficial area of the ear, not accompanied by a visible breach of their anatomical integrity. Most commonly, ear contusion occurs from blows to the superficial area of the ear or falls onto it, when the cartilage of the auricle is not damaged and no subcutaneous or subperichondrial hemorrhage occurs [4]. With more pronounced traumatic impacts, an othematoma develops – an accumulation of blood between the cartilage and perichondrium [5]. The causes of othematoma include injuries to the auricle in wrestlers, boxers, individuals engaged in heavy physical labor, prolonged pressure on the auricle from hard headwear, a hard pillow, or another object placed under the head, a blow to the auricle, or a fall onto it [2, 6, 7]. In cases of bites, cuts, and wounds, a post-traumatic defect of the auricle is observed – a partial breach of the integrity of the soft tissues of the auricle or its complete absence (amputation) [8]. Wound infection can lead to perichondritis of the auricle, its deformation, and cicatricial atresia of the external auditory canal [1, 9].
The causes of isolated rupture of the tympanic membrane can be mechanical, baric, thermal, or chemical influences. Mechanical damage to the tympanic membrane includes the entry of sharp objects into the external auditory canal (twigs, dried plant stems), ear manipulations when patients attempt independent ear toilet using personal hygiene products for the external auditory canal ("Q-tip injury"), iatrogenic injury during ear irrigation, foreign body removal, and active aspiration from the external auditory canal [10, 11]. Ear barotrauma occurs due to a sudden drop in ambient pressure (air during flights, water during diving, etc.), blunt trauma with the palm to the ear, or exposure to a blast wave. Traumatic rupture of the tympanic membrane may also occur in combined skull base injuries: transverse temporal bone fractures and gunshot wounds to the ear. Thermal causes of tympanic membrane rupture include damage from welding slag during electric welding and lightning strikes. Chemical causes involve exposure to aggressive liquids that cause defects upon contacting the tympanic membrane [12]. As a rule, the majority (80%–97%) of traumatic ruptures of the tympanic membrane heal spontaneously within 2–4 weeks [10, 13–16]. In blast injuries resulting in large tympanic membrane perforations, spontaneous closure of defects is observed in fewer cases (56%–82%) and over a longer period (up to 3 months) [17–19]. Tympanic membrane perforations close spontaneously in the majority of cases, regardless of localization, direction of epidermal growth (outward or inward), and the presence of discharge. Only the size of the defect affects the rate of spontaneous healing [13, 16, 20, 21]. Despite the high probability of spontaneous healing of tympanic membrane defects, there remains a risk of tympanic cavity infection caused by non-pathogenic flora in the external auditory canal if precautions are not taken to prevent water from entering the open ear. Furthermore, in blast injuries, rolling of the epithelium from the edges of the perforation, penetration of infected foreign bodies, and dislocation of tympanic membrane remnants into the tympanic cavity contribute to the chronization of the inflammatory process and the formation of intratympanic cholesteatoma in various parts of the tympanic cavity as early as 6 months after the injury [18, 19, 22].
The most common causes of traumatic rupture of the tympanic membrane in children are blunt ear trauma, barotrauma, and foreign bodies in the ear [21]. Penetrating injuries of the middle ear and tympanic membrane in children may be inflicted by cotton swabs, matches, hairpins, etc., by the children themselves or caregivers, or may be iatrogenic during attempts to remove an ear foreign body [23].
1.3 Epidemiology of the Disease or Condition
In 66% of cases, superficial ear injury occurs between the ages of 11 and 40 years and is more common in males. The most frequent causes of ear injuries are traffic accidents (43%), domestic injuries (33%), and fights (14%) [24]. The epidemiology of auricle injuries according to A.F. Bardsley and D.M. Mercer (1983) is as follows: human bites (42%), falls (20%), traffic accidents (16%), dog bites (14%) [25]. The upper third of the auricle is injured most frequently (41%) [26]. In the structure of superficial ear injuries, auricle injuries account for 48%, of which 15% involve soft tissue defects and 33% do not involve defects (othematoma, earlobe injury). Injury to the fibrocartilaginous part of the external auditory canal is observed in 15% of cases. Traumatic injury to both the auricle and the external auditory canal occurs in 33% of cases [27]. Wounds of the external ear and mastoid process account for 10.4% of all ENT organ wounds [28].
Traumatic rupture of the tympanic membrane occurs in 6.80 per 1,000 otolaryngology visits and accounts for 0.43%–2.16% of all ear diseases [29, 30]. The majority of patients are young males (over 75%, with a mean age of about 30 years) [29]. Injury to the left ear due to a slap is more common (66%–79%), followed by sports injuries (ball strike, diving) at 15%, and the use of personal hygiene products for the external auditory canal at 11% [31]. Air pressure changes in a confined space during a gas explosion or the deployment of automobile airbag systems during a traffic accident can also lead to traumatic rupture of the tympanic membrane [30]. In combat trauma during modern armed conflicts, unilateral or bilateral traumatic rupture of the tympanic membrane is observed in 15% of the wounded, despite the use of personal hearing protection devices [17, 19].
1.4 Features of Coding the Disease or Condition
S00.4 – Superficial injury of ear;
S01.3 – Open wound of ear;
S09.2 – Traumatic rupture of tympanic membrane.
Due to the frequent combination of traumatic rupture of the tympanic membrane and acoustic trauma in blast injuries of the ear, these guidelines also address medical care for acoustic barotrauma, which does not have a separate code in ICD, except for H83.3 – Noise effects of inner ear, which includes acoustic trauma and noise-induced hearing loss.
1.5 Classification of the disease or condition
According to the modern classification of ENT organ injuries [28], superficial ear injuries are subdivided into closed injuries (contusions) and wounds. Wounds and contusions of the external ear and the mastoid region are categorized as: a) superficial (without temporal bone damage); b) deep (with temporal bone damage) [32].
According to Yu.N. Rostokin's classification (1975), auricle defects are classified as follows [33]:
Partial defects of the upper part of the auricle (helix, antihelix).
Partial defects of the middle part of the auricle (helix, helix and antihelix with part of the scapha).
Partial defects of the lower part of the auricle (earlobe, lower part of the helix, earlobe).
Subtotal defects of the auricle (with preservation of the scaphoid cartilage, without preservation of the scaphoid cartilage).
Total defects of the auricle.
According to H. Weerda's classification of auricle defects (1998) [24], the following are distinguished:
Central defects (concha, antihelix, scapha, combined central defects).
Peripheral defects (helix and crura of the helix):
- reconstruction with reduction of concha size.
- reconstruction without reducing the size of the auricle.
Partial reconstruction (upper, middle, and lower thirds of the auricle):
- reconstruction with reduction of concha size.
- reconstruction without reducing the size of the auricle.
Earlobe defects.
Posterior defects.
Subtotal defects.
Reconstructions after total loss of the auricle.
Soft tissue defects anterior to the auricle.
Soft tissue defects of the parotid region.
Post-burn defects.
Traumatic tympanic membrane perforation (TTMP) is classified according to the time elapsed since the injury: acute TM perforation (less than 3 months) and chronic persistent TM perforation [34]. Depending on the presence or absence of ear discharge, the following forms are distinguished: TTMP with suppuration or dry perforation [29, 34]. In addition, based on the size of the tympanic membrane defect, TTMPs are classified as small (less than 25% of the area, or less than 1 quadrant), medium (25–50% or 1–2 quadrants), and large (more than 75% or more than 2 quadrants) [34]. The classification of hearing impairment in TTMP, including barotrauma, is carried out in accordance with the current hearing loss classification.
1.6 Clinical presentation of the disease or condition
In superficial injuries of the ear (SIE), the auricle is typically affected. The extent of auricular damage depends on the force and direction of the impact, ranging from minor abrasions and bruises to avulsion and crushing [32].
Auricular contusions are characterized by the presence of othematoma. It is frequently localized in the upper half of the outer surface of the auricle. Othematoma has a characteristic appearance: a fluctuating round swelling with a bluish or purplish hue. The othematoma does not affect the lobule. Its palpation is usually painless [35].
Delayed treatment of othematoma (removal of blood between the cartilage and perichondrium) leads to perichondritis. Clinically, this manifests as severe pain in the auricle and upon its palpation, as well as in the external acoustic meatus, enlargement of the auricle, smoothing of its contours without spreading to the lobule, and fluctuation (upon the formation of purulent exudate between the perichondrium and cartilage). In case of late presentation, purulent melting of the cartilage with sequestration is possible, leading to subsequent deformation and disfigurement of the auricle. Symptoms of general intoxication are observed: fever, insomnia due to severe pulsating pain, loss of appetite, and sometimes chills. Pain may radiate to the temporal, occipital, and cervical regions [1, 36].
In wounds and injuries of the superficial ear zone (SEZ), partial or complete avulsion of the auricle is possible, as well as the development of bleeding from the branches of the external carotid artery and corresponding venous vessels [1]. Despite the variety of such bleedings, they are usually quite moderate. Severe hemorrhages requiring emergency care include injuries to the occipital, temporal, and posterior auricular arteries or their branches. Attention should also be paid to restricted mobility of the mandible (usually pronounced), saliva discharge through the wound, and signs of facial nerve paresis. This will help suspect damage to the temporomandibular joint, parotid salivary gland, peripheral branches of the facial nerve, and facial muscles and tendons. In cases of deeper infection spread during injuries of the outer ear zone, labyrinthitis and intracranial complications may develop [3].
TTMP is typically accompanied by hearing loss, a feeling of ear fullness, and mild tinnitus. The severity of clinical symptoms depends on the nature, force, and duration of the traumatic factor, the presence of associated pathology, and secondary infection [37]. Thus, in barotrauma, hearing loss can reach the degree of deafness; dizziness and balance disorders may occur [12]. In addition, blood discharge from the ear may be present immediately after the injury [38]. In explosive injuries, the severity of damage depends on the type and conditions of the explosion, its power, the direction of the shock wave, and the victim's position relative to the epicenter. Due to the severe general condition of the victim, hearing system injuries are not diagnosed or are diagnosed with a significant delay in half of the cases [17]. In penetrating middle ear trauma in children, injuries include tympanic membrane perforation, ossicular chain disruption, facial nerve injury, stapes footplate injury, perilymphatic fistula, hemotympanum, and may be accompanied by hearing loss, dizziness, otorrhagia, otalgia, nausea, nystagmus, and ataxia [23].
2. Diagnostics, medical indications and contraindications for diagnostic methods
Criteria for diagnosis.
The diagnosis of «ear injury» is established on the basis of:
anamnestic data, physical examination including the physician's assessment of the patient's general condition with careful inspection of the superficial ear zone and assessment of the tympanic membrane state, as well as results of examinations by other specialists; instrumental ear examination – examination of the organ of hearing (otoscopy); laboratory test data.
2.1 Complaints and Anamnesis
A history of mechanical impact on the superficial ear zone (blow, bite, wound, etc.) is important from the anamnesis.
Depending on the type of mechanical impact, a patient with a superficial ear injury presents with complaints of [2, 32, 39]: pain in the SEZ area, soft tissue edema in the SEZ, bleeding, soft tissue defect in the auricle area, abrasions and bruises, hearing loss, dizziness.
In addition, systemic complaints may be observed: malaise, general weakness, fever, headache.
In cases of TTMP, it is necessary to consider anamnestic data regarding the nature of the injury sustained: a sharp drop in ambient pressure (a slap to the ear, rapid descent/ascent while diving, blast wave), piercing action of sharp objects or personal hygiene items during manipulations in the external acoustic meatus, and injuries to the skull base in blast injuries. The main complaints in TTMP are: sharp ear pain at the moment of injury, hearing loss on the side of the damaged tympanic membrane, tinnitus, dizziness, balance disorders, and discharge of blood or cerebrospinal fluid (in case of a skull base fracture) [12].
In addition, patients may note the sound of escaping air from the external acoustic meatus during Valsalva maneuver or blowing the nose. If water enters the external acoustic meatus subsequently, various types of ear discharge (mucus, pus) may appear [13, 40].
2.2 Physical Examination
Assessment of the general condition, general examination, and endoscopic examination of ENT organs make it possible to exclude acute diseases of the middle and inner ear and proceed to the diagnosis of ear injury. The presence of skin defects, in addition to signs of TTMP, as well as blood accumulation in the external acoustic meatus or suspicion of otorrhea, may indicate a skull base fracture (open traumatic brain injury) [12].
It is recommended to perform an initial (examination, consultation) by an otorhinolaryngologist for all patients with suspected ear injury in order to assess reactive changes in the ear, ear functions, general condition, and to identify systemic manifestations [1, 39, 41].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: Local signs of SIE include:
- hyperemia, soft tissue edema in the SEZ area
- fluctuation (upon accumulation of blood or purulent exudate between the perichondrium and cartilage)
- presence of soft tissue defects of the auricle (partial or complete avulsion), cartilaginous part of the external acoustic meatus, and parotid region
- bleeding from the soft tissues of the SEZ.
Otoscopic signs of fresh perforation in TTMP include the presence of a tympanic membrane defect with ragged (non-calloused) edges, which may be everted outward from the tympanic membrane or inverted toward the tympanic cavity. In some cases, traces of blood are detected in the external acoustic meatus in TTMP. Due to the fact that the clinical manifestations of tubotympanitis and barotrauma without TTMP are similar, the conclusion regarding the presence of barotrauma of the ear with an appropriate history is established only in the presence of otoscopic data of TTMP. Persistent TM perforation in TTMP is characterized by calloused edges [17, 22].
Systemic manifestations of ear injury in the event of complications (perichondritis, intracranial complications, etc.) include:
- fever;
- weakness, malaise, general intoxication phenomena;
- pronounced diffuse headache [3].
2.3 Laboratory Diagnostics
It is recommended to perform a complete blood count (CBC) and a general biochemical blood test for all patients with an ear injury to detect the reactive nature of bacterial inflammation, assess the patient's general health status, and identify possible internal organ dysfunctions [41].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
It is recommended to determine the sensitivity of microorganisms to antimicrobial chemotherapeutic drugs by performing microbiological (cultural) examination of purulent discharge for aerobic and facultatively anaerobic microorganisms with determination of pathogen sensitivity to antibacterial drugs in all patients with ear injury in order to prescribe effective therapy [42].
Level of Recommendation CLevel of Evidence 5Level of Recommendation C (Level of Evidence – 5)
Comments: Pseudomonas aeruginosa is most frequently isolated in purulent perichondritis. Other common microorganisms include Staphylococcus aureus, Escherichia coli, and Proteus [43, 44].
2.4 Instrumental Diagnostics
It is recommended to perform hearing tests using tuning forks and pure-tone audiometry in adult patients with ear trauma presenting with complaints of hearing loss, in order to rule out sudden sensorineural hearing loss [12, 23, 42].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5)
Comments: tuning fork tests can be difficult to perform and interpret in young children [23].
Pure-tone threshold audiometry allows for assessing the presence and degree of conductive hearing loss and suspecting potential damage to middle ear structures. The presence of a sensorineural component may indicate inner ear damage.
It is recommended to perform computed tomography of the temporal bone in all patients with complicated forms of the disease (perichondritis, abscess, etc.) and when temporal bone injury, ossicular chain damage, or perilymphatic fistula is suspected, in order to clarify the diagnosis and select the correct treatment tactics [23, 45].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
Comments: in penetrating middle ear trauma, localization of the tympanic membrane perforation in the posterosuperior quadrant may indicate potential damage to the auditory ossicles or the inner ear, which necessitates computed tomography of the temporal bone [23].
2.5 Other Procedures
It is recommended to have an initial consultation (examination, evaluation) with a neurologist, an initial maxillofacial surgeon, and an initial neurosurgeon for patients with ear trauma and concomitant pathology (jaw fracture, parotid salivary gland injury, facial nerve injury, etc.) in order to rule out profile pathology and conduct additional examination [5].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
Auricular contusions do not require special treatment. In the presence of skin abrasions, they are treated with antiseptic solutions, and an aseptic dressing or patch is applied [2].
3.1. Conservative management
It is recommended to use non-steroidal anti-inflammatory drugs (ATC code M01A "Non-steroidal anti-inflammatory and antirheumatic products") in patients with acute mechanical trauma to the ear (AMTE) to reduce pain, depending on the severity of the pain syndrome [47].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: In children, the use of non-steroidal anti-inflammatory and antirheumatic products (NSAIDs) (ATC: M01A) is limited to ibuprofen** (ATC: M01AE01) from 3 months of age for rectal suppositories and oral suspension, from 6 years for tablets, and from 12 years for capsules; and ketoprofen** (ATC: M01AE03) from 6 years for oral granules and from 15 years for parenteral forms.
Table 1. Recommended doses and regimens of analgesic therapy in adults for ear injuries.
Drug | Single dose | Dosing interval | Maximum daily dose | Maximum duration of administration |
|---|---|---|---|---|
Diclofenac** (ATC: M01AB05) | 75 mg IM | 12 h | 150 mg | 2 days |
Ketorolac** (ATC: M01AB15) | 30 mg IV, IM | 6 h | 60–90 mg | 2 days |
Ketoprofen** (ATC: M01AE03) | 100 mg IV, IM | 12 h | 200 mg | no more than 2 days |
Lornoxicam (ATC: M01AC05) | 8 mg IV, IM | 12 h | 16 mg | 1–7 days |
Dexketoprofen** (ATC: M01AE17) | 50 mg IV, IM | 8–12 h | 150 mg | 2 days |
Table 2. Recommended doses and regimens of analgesic therapy in children for ear injuries.
Drug | Single dose | Dosing interval | Maximum daily dose | Maximum duration of administration |
|---|---|---|---|---|
Ibuprofen** (ATC: M01AE01) | Oral: 10–12 years – 300 mg; 7–9 years – 200 mg 4-6 years – 150 mg; 1-3 years – 100 mg; 6–12 months – 50 mg 3-6 months – 50 mg | 8 h 8 h 6–8 h 8 h | 10–12 years – 900 mg; 7–9 years – 600 mg 4-6 years – 450 mg; 1-3 years – 300 mg; 6-12 months – 200 mg; 3-6 months – 150 mg | 3–5 days |
Ibuprofen** (ATC: M01AE01) | Rectal. 3-9 months – 60 mg 9–24 months – 60 mg | 8 h 6 h | 3–9 months – 180 mg 9–24 months – 240 mg | no more than 3 days |
Ketoprofen** (ATC: M01AE03) | from 15 years – 100 mg IV, IM | 12 h | 200 mg | no more than 2 days |
Ketoprofen** (ATC: M01AE03) | Oral. >6 years – 40 mg | 8 h | 120 mg | no more than 2 days |
It is recommended to use antiseptics and antibacterial ointments topically in patients with AMTE to relieve infectious and inflammatory manifestations in the wound area [46, 48–50].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: Quaternary ammonium compounds (benzyldimethyl[3-(myristoylamino)propyl]ammonium chloride monohydrate (ATC D08AJ)), iodine preparations (povidone-iodine** (D08AG02)), and biguanides and amidines (chlorhexidine** (D08AC02)) exhibit pronounced antimicrobial properties. Other topical antibiotics (ATC: D06AX) are used in adults: chloramphenicol (ATC: D06AX02), neomycin (ATC: D06AX04), bacitracin+neomycin (ATC: D06AX05), mupirocin (ATC: D06AX09). Neomycin (ATC: D06AX04), bacitracin (ATC: D06AX05), and mupirocin (ATC: D06AX09) are not used in children. The frequency of wound care depends on the severity of inflammation and the nature of the exudate. The wound is treated until the infection resolves or healing begins [45, 63].
It is recommended to administer tetanus toxoid (ATC code J07AM "Tetanus vaccines") to patients with AMTE who have infected and contaminated wounds for the purpose of tetanus prophylaxis [1, 47].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
It is recommended to prescribe early systemic antibiotic therapy (third-generation (ATC: J01DD) and fourth-generation (ATC: J01DE) cephalosporins, fluoroquinolones (ATC: J01MA)) to patients with AMTE in the presence of an infected wound, as well as AMTE complicated by perichondritis of the auricle, to prevent purulent-septic complications [49, 51, 52].
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).
Comments: The approximate duration of antibacterial therapy is 7–10 days. Fluoroquinolone antibiotics (ATC: J01MA) are used only in adult patients.
Only fourth-generation cephalosporins (ATC: J01DE) may be prescribed for children
It is recommended to adopt an expectant management approach for patients with small traumatic ruptures of the tympanic membrane (<25% of the tympanic membrane area), with the exception of blast injuries, for dynamic observation [13].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: When signs of inflammation (otorrhea) develop, systemic antibacterial drugs are indicated for patients with traumatic rupture of the tympanic membrane to relieve them [13].
3.2. Surgical treatment.
It is recommended to eliminate othematoma in all patients with AMTE to prevent complications (perichondritis) [6; 50; 53].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
Comments: Prior to the procedure, local infiltration anesthesia in the intervention area is performed using local anesthetic solutions (0.5% procaine** (ATC code N01BA "Aminobenzoic acid esters") for adults and children over 12 years of age; 2% lidocaine** (ATC code N01BB "Amides") for adults only). If less than 48 hours have passed since the injury and the diameter of the othematoma is less than 2 cm, aspiration should be performed using a disposable injection needle (18G). The needle insertion point is at the base of the hematoma. If the ear hematoma is larger than 2 cm in diameter or more than 48 hours have passed since the injury, incision and drainage of the othematoma are performed. The incisions made should not disrupt the cosmetic appearance of the external ear. To prevent hematoma recurrence, a circular pressure dressing is applied or other methods are used (mattress sutures, magnetic fixation, etc.) [54, 55].
It is recommended to perform opening and drainage of auricular abscess cavities, with the removal of necrotic tissue areas in all patients with purulent perichondritis of the auricle to prevent purulent-septic complications [51].
GDR CLE 5Grade of recommendation C (level of evidence – 5)
It is recommended to repair auricle defects in all patients with AMTE who have partial and total auricle defects in order to restore its shape [53, 55].
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
Comments: Surgical debridement of external wounds of the auricle should be performed as early as possible. The cosmetic aspect of the surgery should be taken into account. In this regard, only clearly non-viable soft tissues are allowed to be removed, followed by primary suturing. In cases where approximation of the wound edges involves high tension, guiding sutures are applied [2, 3]. In cases of partial amputation of the auricle,...
It is recommended to insert sterile soft elastic tubes into the lumen of the external auditory canal to restore its patency in patients with trauma to the fibrocartilaginous part of the external auditory canal [3].
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
It is recommended for patients with small and medium-sized traumatic ruptures of the tympanic membrane (<50% of the tympanic membrane area), excluding blast injuries, to perform conservative myringoplasty using various materials for external auditory canal tamponade (collagen hemostatic sponge (B02BC)) in order to increase the success rate of spontaneous healing of the tympanic membrane defect [14, 57, 59, 61].
GRC BLEL 2Grade of Recommendation B (Level of Evidence – 2)
Comments: Conservative myringoplasty is performed under local topical or infiltration anesthesia with lidocaine** solutions (N01BB02) – 10% and 1%, respectively (except for children under 1 year of age), or similar drugs using magnifying optical equipment. An ear speculum is sufficient for access. Materials used for external auditory canal tamponade, as well as silicone or latex plates, serve as a supporting framework for the spontaneous spreading of the tympanic membrane tear edges and its regeneration. After careful toilet of the external auditory canal and, if necessary, freshening the edges of the tympanic membrane perforation, the material is tightly placed over the defect, overlapping it. The size of the material must exceed the size of the tympanic membrane perforation. Following conservative myringoplasty, water getting into the ear, intratympanic use of medications, forced autoinflation, sneezing, and nose-blowing must be avoided [62].
A follow-up examination of the patient after conservative myringoplasty is performed in 2–4 weeks. The appearance of ear discharge or hearing loss may be due to middle ear inflammation or displacement of the material from the defect. In this case, an examination is recommended to determine further patient management. Removal of the plastic material should be carried out no earlier than 4 weeks later [62].
In children, conservative myringoplasty is performed under combined inhalation anesthesia or intravenous analgesia. The surgical algorithm is the same as in adults; in addition to the listed materials, cigarette paper is also used [21].
It is recommended to perform tympanotomy in pediatric patients with ear trauma and vestibular symptoms in order to diagnose and eliminate a perilymphatic fistula [23, 63].
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comments: in children with ear trauma presenting with sensorineural hearing loss, balance disorders, dizziness, nystagmus toward the affected side, as well as tympanic membrane perforation in the posterosuperior quadrant, the presence of a perilymphatic fistula should be suspected.
Diagnostic tympanotomy is the gold standard in the diagnosis and treatment of perilymphatic fistula. The surgery is performed under combined endotracheal anesthesia. A tympanomeatal flap is elevated, and the posterior parts of the tympanic cavity are inspected for any signs of trauma, with special attention paid to the round and oval windows. If there are overt signs of trauma, such as a fracture of the stapes footplate or the round window niche, bone fragments should be removed or returned to their normal position when possible. If no overt signs of trauma are found, after aspiration of mucus, blood, or local anesthetic from the tympanic cavity, the round and oval window regions are observed for fluid accumulation for at least 5 minutes. If clear fluid continues to accumulate in the round and/or oval window regions even after repeated aspiration, a diagnosis of perilymphatic fistula is made. Then, tissue grafts of fat or fascia are placed over the oval and round windows, and the flap is closed. Vestibular symptoms usually resolve after defect closure.
It is recommended to perform tympanoplasty in all patients with traumatic rupture of the tympanic membrane in case of the formation of a persistent tympanic membrane perforation in order to restore its integrity [17-19, 62, 64].
GCR BLEL 5Grade of Recommendation B (Level of Evidence – 5)
Comments: Surgical intervention on the ear for traumatic rupture of the tympanic membrane, even in the presence of signs of spontaneous healing, is indicated when a fracture (dislocation) of the auditory ossicles, middle ear cholesteatoma, or traumatic labyrinthine window fistula is suspected (persistence of vestibular disorders for more than 2 weeks, an air-bone gap of more than 30 dB, mixed hearing loss, etc.) [12, 62].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
Prevention of external ear trauma consists of compliance with safety regulations at work, during sports, etc., as well as the use of head personal protective equipment (helmets, hard hats, etc.).
6. Organization of Medical Care
Indications for emergency hospitalization in a medical organization for inpatient treatment:
1) presence of complications of superficial ear trauma (perichondritis, mastoiditis, etc.);
2) need for surgical interventions (repair of the auricle and external auditory canal defects, etc.).
Indications for discharging a patient from a medical organization:
1) stabilization of general condition (no febrile temperature, no signs of intoxication);
2) normalization of complete blood count parameters;
3) normal wound healing.
7. Additional Information
The prognosis for acute mechanical trauma of the ear, provided adequate treatment is given, is favorable in most cases.
Lack of treatment or inadequate treatment of acute mechanical trauma of the ear is fraught with a high probability of purulent complications: perichondritis, acute purulent otitis media, mastoiditis, labyrinthitis, intracranial complications, phlegmon, abscess.
The prognosis for traumatic rupture of the tympanic membrane is favorable in most cases, given the high probability of spontaneous healing of the tympanic membrane defect. The development of middle ear inflammation with adequate treatment does not affect the outcome of the disease, but affects its duration [13].
Criteria for Evaluating the Quality of Medical Care
Quality criteria for primary health care delivered to adults and children with ear trauma (ICD-10 codes: S00.4, S01.3, S09.2)
№ | Quality criteria | Evaluation of compliance |
|---|---|---|
1. | Consultation (examination, evaluation) by an otorhinolaryngologist, general practitioner (family physician), or pediatrician was performed | Yes/No |
2. | Otoscopy was performed | Yes/No |
3. | A referral for hospitalization was issued for patients with complicated forms of ear trauma | Yes/No |
Quality criteria for specialized medical care delivered to adults and children with ear trauma (ICD-10 codes: S00.4, S01.3, S09.2)
№ | Quality criteria | Evaluation of compliance |
|---|---|---|
1. | Consultation (examination, evaluation) by an otorhinolaryngologist was performed | Yes/No |
2. | Determination of microorganism susceptibility to antimicrobial chemotherapy drugs was performed | Yes/No |
3. | Systemic antibacterial therapy was administered | Yes/No |
4. | Pure-tone threshold audiometry was performed | Yes/No |
5. | Primary surgical debridement of the ear wound was performed | Yes/no |
References
Show references
"Military Field Surgery: National Guidelines", ed. by I. M. Samokhvalov. — 2nd ed., rev. and supp. — Moscow: GEOTAR-Media, 2024. — 585 p.
Blotsky A.A., Karpishchenko S.A., Antipenko V.V., Blotsky R.A. Injuries and Foreign Bodies of ENT Organs. - St. Petersburg: "Dialog". - 2019. - 223 p.
Egorov V. I., Kozarenko A. V. Diagnosis and treatment of combat ear injuries. Almanac of Clinical Medicine. 2016; 44:7:841-849. https://doi.org/10.18786/2072-0505-2016-44-7-841-849.
Thill MP, Horoi M, Ostermann K, Depuydt C, Deschamps M, Ducène C. Acute external ear lesions: clinical aspects, assessment and management. B-ENT. 2016;Suppl 26(1):155-171. PMID: 29461740.
Toft-Nielsen C, Lyneborg N. [External ear traumas and their complications]. Ugeskr Laeger. 2019 Nov 11;181(46):V06190340. Danish. PMID: 31791462.
Ingvaldsen CA, Tønseth KA. Auricular haematoma. Tidsskr Nor Laegeforen. 2017 Jan 24;137(2):105-107. English, Norwegian. doi: 10.4045/tidsskr.15.1279. PMID: 28127072.
Greywoode JD, Pribitkin EA, Krein H. Management of auricular hematoma and the cauliflower ear. Facial Plast Surg. 2010 Dec;26(6):451-5. doi: 10.1055/s-0030-1267719. Epub 2010 Nov 17. PMID: 21086231.
Al-Ali MA, Abu-Zidan FM. Auricular avulsion injuries: Literature review and management algorithm. Turk J Emerg Med. 2022 Apr 11;22(2):59-66.
Prasad HK, Sreedharan S, Prasad HS, Meyyappan MH, Harsha KS. Perichondritis of the auricle and its management. J Laryngol Otol. 2007 Jun;121(6):530-4.
Lou Z.C., Lou Z.H., Zhang Q.P. Traumatic tympanic membrane perforations: a study of etiology and factors affecting outcome // Am J Otolaryngol. W.B. Saunders, 2012. Vol. 33, № 5. P. 549–555.
Sagiv D. et al. Traumatic Perforation of the Tympanic Membrane: A Review of 80 Cases // J Emerg Med. 2018. Vol. 54, № 2. P. 186–190.
Wackym P.A., Snow J.B. Ballenger’s Otorhinolaryngology Head and Neck Surgery. 18th ed. Pmph USA Ltd, 2016. 1523 p.
Jellinge M.E., Kristensen S., Larsen K. Spontaneous closure of traumatic tympanic membrane perforations: observational study // J Laryngol Otol. 2015. Vol. 129, № 10. P. 950–954.
Lou Z.C., Hu Y.X., Tang Y.M. Effect of treatment at different time intervals for traumatic tympanic membrane perforation on the closure // Acta Otolaryngol. 2011. Vol. 131, № 10. P. 1032–1039.
Lou Z.C., Hu Y.X., Tang Y.M. Prognosis and outcome of the tympanic membrane flap at traumatic tympanic membrane perforation edge // ORL. 2011. Vol. 73, № 4. P. 212–218.
Lou Z.C., Tang Y.M., Yang J. A prospective study evaluating spontaneous healing of aetiology, size and type-different groups of traumatic tympanic membrane perforation // Clin Otolaryngol. 2011. Vol. 36, № 5. P. 450–460.
Ritenour A.E. et al. Tympanic membrane perforation and hearing loss from blast overpressure in Operation Enduring Freedom and Operation Iraqi Freedom wounded // J Trauma. 2008. Vol. 64, № 2 Suppl. P. S174–S178.
Sridhara S.K., Rivera A., Littlefield P. Tympanoplasty for blast-induced perforations: The walter reed experience // Otolaryngology - Head and Neck Surgery (United States). 2013. Vol. 148, № 1. P. 103–107.
Song S.A., Sridhara S.K., Littlefield P.D. Tympanoplasty Outcomes for Blast-Induced Perforations from Iraq and Afghanistan: 2007-2012 // Otolaryngology - Head and Neck Surgery (United States). SAGE Publications Inc., 2017. Vol. 156, № 2. P. 353–359.
Orji F.T., Agu C.C. Determinants of spontaneous healing in traumatic perforations of the tympanic membrane // Clin Otolaryngol. 2008. Vol. 33, № 5. P. 420–426.
Cayir S., Mutlu H. Traumatic tympanic membrane perforation in children in the emergency department: comparison of spontaneous closure and paper patch // Cureus. – 2020. – Vol. 12. – No. 4.
Garov E.V. et al. Treatment of patients with functional auditory system impairment in explosive barotrauma // Vestn. Otorinolaringologii. 2005. Vol. 4. P. 35–37.
Neuenschwander M. C. et al. Penetrating middle ear trauma: a report of 2 cases // Ear, Nose & Throat Journal. – 2005. – Vol. 84. – No. 1. – P. 32-35.
Steffen A, Klaiber S, Katzbach R, Nitsch S, Frenzel H, Weerda H. Zur Epidemiologie von Ohrmuschelverletzungen [Epidemiology of auricular trauma]. Handchir Mikrochir Plast Chir. 2007 Apr;39(2):98-102. German. doi: 10.1055/s-2007-965136.
Bardsley AF, Mercer DM. The injured ear: a review of 50 cases. Br J Plast Surg. 1983 Oct;36(4):466-9. doi: 10.1016/0007-1226(83)90131-5. PMID: 6626828.
Kolodzynski MN, Kon M, Egger S, Breugem CC. Mechanisms of ear trauma and reconstructive techniques in 105 consecutive patients. Eur Arch Otorhinolaryngol. 2017 Feb;274(2):723-728. doi: 10.1007/s00405-016-4299-4. Epub 2016 Oct 6. PMID: 27714497; PMCID: PMC.
Gysan A.O. Epidemiology and structure of traumatic ear injuries in the Karachay-Cherkess Republic / A. O. Gysan, B. B. Uraskulova, Kh. A. Uzdenova // Russian Otorhinolaryngology. – 2021. – Vol. 20, No. 5(114). – P. 13-18. – DOI 10.18692/1810-4800-2021.
Guidelines for the Treatment of Combat Surgical Trauma, Moscow: Main Military-Medical Directorate of the Russian Ministry of Defense; 2022; 48 p.
Wahid F.I., Nagra S.R. Incidence and characteristics of Traumatic Tympanic Membrane perforation // Pak J Med Sci. Professional Medical Publications, 2018. Vol. 34, № 5. P. 1099.
Habarth-Morales T.E. et al. Incidence and Epidemiology of Traumatic Tympanic Membrane Rupture: A National Trauma Data Bank Analysis // Journal of Craniofacial Surgery. Lippincott Williams and Wilkins, 2023. Vol. 34, № 1. P. 168–172.
Kraus F., Hagen R. Ätiologie und Therapie der traumatischen Trommelfellperforation // Laryngo-Rhino-Otologie. 2015. Vol. 94, № 09. P. 596–600.
Govorun M.I., Gorokhov A.A. Injury of ENT Organs and Neck in Peacetime and Wartime: A Guide for Physicians. - SpetsLit, 2010. - 126 p.
Karyakina I.A. Methods of surgical correction of post-traumatic subtotal auricular defects. // Ural Medical Journal. Yekaterinburg, 2011, No. 14, P. 135-138.
Wahid F.I. et al. Aftermath of traumatic tympanic membrane perforation: Our findings at a tertiary care hospital in Pakistan // Pak J Med Sci. Professional Medical Publications, 2021. Vol. 37, № 3. P. 874.
Babiyak V. I., Nakatis Ya. A. Clinical Otorhinolaryngology: A Guide for Physicians. St. Petersburg: Hippocrates, 2005. 800 p.
Blotsky A.A., Karpishchenko S.A. Emergencies in Otorhinolaryngology. - St. Petersburg: Dialog. - 130 p.
Fedorova O.V. Types of ear structure injuries depending on the injury mechanism // Vestn. Otorinolaringologii. 1998. No. 1. P. 53–55.
Afolabi O.A. et al. Traumatic tympanic membrane perforation: An aetiological profile // BMC Res Notes. 2009. Vol. 2.
Das, J. (2018). Trauma to Ear. In: Trauma in Otolaryngology. Springer, Singapore.pp.55-80.
Sogebi O.A., Oyewole E.A., Mabifah T.O. Traumatic tympanic membrane perforations: characteristics and factors affecting outcome // Ghana Med J. 2018. Vol. 52, № 1. P. 34–40.
Otorinolaringologiya: Natsionalnoe rukovodstvo. Pod red. V.T. Palchuna. M.: GEOTAR-Media, 2016: 960 p.
Rosenfeld R. M. et al. Clinical practice guideline: acute otitis externa // Otolaryngology – Head and Neck Surgery. – 2014. – Vol. 150. – No. 1_suppl. – P. S1-S24.
Forozidou E, Poutoglidis A, Tsetsos N, Kilmpasanis A, Fyrmpas G. Surgery as a Last Resort for Persistent Auricular Perichondritis. Ear Nose Throat J. 2024 Feb;103(2):81-83. doi: 10.1177/01455613211038343.
Klug TE, Holm N, Greve T, Ovesen T: Perichondritis of the auricle: bacterial findings and clinical evaluation of different antibiotic regimens. Eur Arch Otorhinolaryngol. 2019, 276:2199-2203. 10.1007/s00405-019-05463-z.
Mazón M, Pont E, Albertz N, Carreres-Polo J, Más-Estellés F. Imaging of post-traumatic hearing loss. Radiologia (Engl Ed). 2018 Mar-Apr;60(2):119-127. English, Spanish. doi: 10.1016/j.rx.2017.07.005.
Shevchik E.A., Nikiforova G.N., Svistushkin V.M. Some aspects of the therapy of inflammatory diseases of the external ear. RMJ. 2014;9:655.
Maltseva, L.A. Tetanus: a review of current recommendations on epidemiology, etiology, pathogenesis, clinical features, and intensive care in wartime and peacetime — 2017. — (3). — P. 86–91.
Gurov A.V., Yushkina M.A., Guseva O.A., Muratov D.L., Sokolov S.S. Topical issues of the clinical course and therapy of otitis externa. Medical Council. 2015;(15):56-58. https://doi.org/10.21518/2079-701X-2015-15-56-58.
Steffen A., Frenzel H. Trauma management of the auricle // Facial Plastic Surgery. – 2015. – Vol. 31. – No. 04. – P. 382-385.
Zimmerman Z. A., Sidle D. M. Soft tissue injuries including auricular hematoma management // Modern Approaches to Facial and Athletic Injuries, An Issue of Facial Plastic Surgery Clinics of North America – 2021. – Vol. 30. – No. 1. – P. 15.
Turovsky A.B., Popova I.A., Shadrin G.B. Modern approaches to the treatment of otitis externa of various etiologies. RMJ. 2017;6: P. 420-423.
Fisher CG, Kacica MA, Bennett NM. Risk factors for cartilage infections of the ear. Am J Prev Med. 2005 Oct;29(3):204-9. doi: 10.1016/j.amepre.2005.06.003. PMID: 16168869.
Nojoumi A, Woo BM. Management of Ear Trauma. Oral Maxillofac Surg Clin North Am. 2021 Aug;33(3):305-315. doi: 10.1016/j.coms.2021.04.001. Epub 2021 Jun 9. PMID: 34116906.
Haik J, Givol O, Kornhaber R, Cleary M, Ofir H, Harats M. Cauliflower ear - a minimally invasive treatment method in a wrestling athlete: a case report. Int Med Case Rep J. 2018 Jan 18;11:5-7. doi: 10.2147/IMCRJ.S152145.
Kurbanov U.A., Davlatov A.A., Nuraliev Z.F., Saidov I.Z. Traumatic auricular defects and their surgical treatment // Payomi Sino (Avicenna Bulletin). - 2008. - No. 4. - P. 18-28.
Kim J. et al. Comparison of methods for the repair of acute tympanic membrane perforations: Silk patch vs. paper patch // Wound Repair Regen. 2010. Vol. 18, № 1. P. 132–138.
Lou Z.C., He J.G. A randomised controlled trial comparing spontaneous healing, gelfoam patching and edge-approximation plus gelfoam patching in traumatic tympanic membrane perforation with inverted or everted edges // Clin Otolaryngol. 2011. Vol. 36, № 3. P. 221–226.
Sayin I. et al. A prospective controlled trial comparing spontaneous closure and Epifilm® patching in traumatic tympanic membrane perforations // European Archives of Oto-Rhino-Laryngology. Springer, 2013. Vol. 270, № 11. P. 2857–2863.
Simsek G., Akin I. Early paper patching versus observation in patients with traumatic eardrum perforations: Comparisons of anatomical and functional outcomes // Journal of Craniofacial Surgery. Lippincott Williams and Wilkins, 2014. Vol. 25, № 6. P. 2030–2032.
Hanege F.M. et al. Comparing spontaneous closure and paper patching in traumatic tympanic membrane perforations // Journal of Craniofacial Surgery. Lippincott Williams and Wilkins, 2018. Vol. 29, № 7. P. 1922–1924.
Cayir S, Mutlu H. Traumatic Tympanic Membrane Perforation in Children in the Emergency Department: Comparison of Spontaneous Closure and Paper Patch. Cureus. 2020 Apr 16;12(4):e7697.
Kryukov A.I. et al. Diagnosis and management of middle ear injuries in the outpatient setting. Moscow, 2020. 18 p.
Kim S. H., Kazahaya K., Handler S. D. Traumatic perilymphatic fistulas in children: etiology, diagnosis and management // International Journal of Pediatric Otorhinolaryngology. – 2001. – Vol. 60. – No. 2. – P. 147-153.
Patyakina O.K., Fedorova O.V., Voronin M.S. Diagnostic criteria and management tactics in traumatic injuries of ear structures // Vestn. Otorinolaringologii. 2000. No. 5. P. 39–42.
Appendix A1. Working Group Composition
Dvoryanchikov V.V., MD, Prof. – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.
Syroezhkin F.A., MD – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.
Egorov V.I., MD, Prof. – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.
Kuznetsov M.S., MD – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.
Alekseenko S.I., MD, Assoc. Prof. – Member of the National Medical Association of Otorhinolaryngologists, no conflict
Diab K.M., MD – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest. of interest.
Tkachuk I.V., PhD – Member of the National Medical Association of Otorhinolaryngologists, no conflict of interest.
Appendix A2. Methodology for Developing Clinical Guidelines
The clinical guidelines summarize the authors' experience in the diagnosis and treatment of patients with various forms of ear trauma. The clinical guidelines contain information necessary for the diagnosis, differential diagnosis, and selection of treatment methods for patients with superficial ear trauma.
Target audience of the clinical guidelines:
general practitioners (family doctors);
otorhinolaryngologists;
otorhinolaryngologist-audiologists;
senior physicians of emergency medical service stations (departments);
emergency physician;
general practitioners.
Table 1. Scale for assessing levels of reliable evidence (LRE) 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. Levels of Evidence (LoE) grading scale for prevention, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (preventive, therapeutic, and rehabilitative 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 the grades of recommendation (GR) for prevention, diagnostic, treatment, and medical rehabilitation methods, including those based on natural therapeutic factors (preventive, diagnostic, therapeutic, and rehabilitative 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 on 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
Regulatory and legal documents
Procedure for the provision of medical care in the specialty of "otorhinolaryngology": Order of the Ministry of Health of the Russian Federation No. 905n dated November 12, 2012, "On Approval of the Procedure for the Provision of Medical Care to the Population in the Specialty of 'Otorhinolaryngology'." Order of the Ministry of Health and Social Development of the Russian Federation No. 366n dated April 16, 2012, "On Approval of the Procedure for the Provision of Pediatric Care";
State Register of Medicinal Products: https://grls.rosminzdrav.ru
Order of the Ministry of Health of the Russian Federation No. 205n dated May 2, 2023 (as amended on December 4, 2023), "On Approval of the Nomenclature of Positions of Medical Workers and Pharmaceutical Workers."
Order of the Ministry of Health of the Russian Federation No. 541n dated July 23, 2010. "Unified Qualification Handbook of Positions of Managers, Specialists, and Employees, Section: Qualification Characteristics of Positions of Healthcare Workers."
Federal Law No. 489-FZ dated December 25, 2018, "On Amendments to Article 40 of the Federal Law 'On Compulsory Medical Insurance in the Russian Federation' and the Federal Law 'On the Fundamentals of Public Health Protection in the Russian Federation' regarding Clinical Guidelines".
Order of the Russian Ministry of Health No. 103n dated February 28, 2019, "On approval of the procedure and timelines for the development of clinical guidelines, their revision, the standard template of clinical guidelines, and requirements for their structure, composition, and scientific validity of the information included in the clinical guidelines."
Appendix A3. Reference materials, including compliance of indications and contraindications, routes of administration and doses of drugs, and drug package inserts
Clarification of notes
** – a medicinal product included in the List of Vital and Essential Drugs for medical use for 2020 (Decree of the Government of the Russian Federation No. 2406-r dated October 12, 2019)
# – off-label use outside the indications registered in the medicine's instructions is carried out by decision of the medical commission, with the permission of the Local Ethics Committee of the medical organization (if any), subject to the signed informed consent of the parents (legal representative) and the patient over 15 years of age.
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
In case of a superficial ear trauma or traumatic rupture of the tympanic membrane (TRTM), the patient should consult an otorhinolaryngologist. The diagnostic algorithm is determined by the otorhinolaryngologist after examination. Management tactics are determined by the otorhinolaryngologist after establishing a clinical diagnosis.
If surgical management is chosen, the patient must be warned about potential complications associated with both the surgical intervention and the refusal of it. After discharge from the hospital, the patient should be under dispensary follow-up by an otorhinolaryngologist and follow their recommendations.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Not applicable