Abstract Introduction Blast injuries in modern warfare are common, and tympanic perforation is often found. Spontaneous closures of large perforations that encompass greater than 80% of the tympanic surface are rare. Early closure of the tympanic membrane avoids the immediate infectious risk, which potentially complicates the initial management of these war-wounded patients, and allows for safe and early recovery of military activity. This study compared the outcomes of spontaneous closures and early biomembrane myringoplasty in subjects with large blast injury-induced tympanic perforation following a massive explosion. Materials and Methods This is a retrospective, observational, cohort study military troops with large barotraumatic tympanic membrane perforation. The study investigates early surgical tympanoplasty versus observation for spontaneous closure. The hearing loss, tympanic perforation closure rate, and closure time were noted. Results Fourteen patients (19 ears) were referred from May 2008 to April 2017, and 6 patients (9 ears) underwent early myringoplasty. A total of 89% (n = 8) and 100% (n = 9) of the ears exhibited successful sealing of the perforation at one and 6 mo, respectively. In contrast, 60% (n = 6) of the 10 ears (8 patients) without initial myringoplasty did not heal spontaneously at 6 mo, and these ears underwent a delayed tympanoplasty procedure. Notably, patients with early myringoplasty suffered lower conductive hearing loss and fewer functional signs remotely. Conclusion Early myringoplasty using a biomembrane for blast injury-induced large tympanic perforation is a fast and minimally invasive method to achieve earlier tympanic closure and a higher closure rate for safe recovery of activity. It can be performed under general anesthesia concurrently with surgery for additional body-wide trauma. The deployment of ENT surgeons on the battlefield in the French Army has enabled early management of these patients. INTRODUCTION Blast injuries are common in military settings (49–63% of war injuries depending on the series).1,2 The types of injuries encountered in operations have changed with the evolution of conflicts, including the emergence of improvised explosive devices, and because of tactical combat casualty care and protective equipment for the trunk and skull, which increase the relative incidence of head and neck injuries. Thirteen percent of blast injuries in the French Army in Afghanistan affected the ear.2,3 Primary blast injuries are related to the blast wave and particularly involve the tympanic membrane.4,5 The severity of tympanic membrane injuries is partially due to the immediate infectious risk, which potentially complicates the initial management of these war-injured patients, their auditory status and post-traumatic cholesteteatoma risk.3 The historical literature supports an inverse relationship between perforation size and spontaneous closure rate.6–8 These risks justify early and specialized management. The North Atlantic Treaty Organization (NATO) now requires the presence of an ENT surgeon for the management of these injuries at NATO Role III.9 Soldiers wounded in the head in combat are now supported by a specialist surgeon on the battlefield and are subsequently managed as patients in France. This retrospective study compared the outcomes of spontaneous closure and early biomembrane myringoplasty in subjects with large tympanic perforation from blast injuries. MATERIAL AND METHODS Subjects This study was a retrospective study of all military patients who were referred with large tympanic perforation after exposure to massive explosions to Percy and Legouest Military Training Hospitals (Clamart and Metz, France) from May 2008 to April 2017. Blast injuries of the ear are defined as trauma to the ear resulting from exposure to an explosion. Massive explosions are defined as loads greater than 5 kg and bombs used in terrorist attacks.10 The initial management of patient injuries in this study occurred at the site of the explosion and secondary support was provided in France at a military hospital. Large tympanic perforation is defined as perforation that encompasses greater than 80% of the tympanic surface.6–8 Patients who suffered underwater blast injuries, non-explosive blast injuries (e.g., slap or punch), isolated acoustic traumas, injuries resulting from minor explosions and patients who were killed in action were excluded from the study. The hospital ethics committee exempted this study from the need for consent because it only involved data retrieval from medical records (Scientific Committee for Clinical Trials of the Percy Hospital, February 2017). Methods The medical files were retrospectively examined, and the following data were analyzed: age, gender, reported functional signs, initial pure tone audiometry initially and at 1 mo, mean hearing loss in terms of audiometric air-bone gap (ABG) in each ear (Mean ABG = (500 Hz + 1000 Hz + 2000 Hz + 4000 Hz)/4), tympanic perforation closure rate and closure time. Tympanic perforations were left to heal spontaneously from 2008 to 2014, and only perforations that did not heal spontaneously within 6 mo underwent tympanoplasty.3,11 Patients underwent early surgery with eversion of the edges of tympanic perforation and the establishment of a hyaluronic acid patch (EpiDisc Otologic Lamina) under general anesthesia or local anesthesia from 2014 to 2017. The Epidisc was removed at 3 mo, in consultation, under a microscope.12 EpiDisc Otologic Lamina (Xomed-Medtronic, Jacksonville, FL, USA) is a biomaterial scaffold composed of esterified hyaluronic acid in an 8-mm diameter disc configuration (Fig. 1). This configuration provides a scaffold on the tympanic membrane during myringoplasty or tympanoplasty procedures. FIGURE 1. View largeDownload slide EpiDisc Otologic Lamina. FIGURE 1. View largeDownload slide EpiDisc Otologic Lamina. Primary outcome parameters were tympanic perforation closure time, closure rate, and the mean ABG. Statistical analysis Prism 7 (GraphPad Software) was used for statistical analyses. The Mann–Whitney U-test was used to compare quantitative data, and Fisher’s exact test was used to compare qualitative data. Any p-value <0.05 was considered significant. RESULTS The files of 14 patients (12 men and 2 women) were collected and analyzed. Patients had a mean age of 34 ± 11 yr (range 22–57 yr) at the time of injury. Five patients presented with bilateral involvement. Therefore, 19 ears were included in the study protocol. Audiometric follow-up lasted an average of 1 mo. Eight patients (10 ears) did not undergo early surgery and were initially followed up with observation only (Group A). Six patients (9 ears) underwent early myringoplasty (Group B) within 3 d. The French soldiers in our study were all wounded in action in Afghanistan and Mali. Blast injuries of the ear were frequently related to terrorist attacks (89%), with improvised explosive devices being the most common explosive device (88%). Patients with early myringoplasty exhibited significantly better closure rates at 1 and 6 mo (Table I). Sixty percent (n = 6) of the ears in group A did not heal spontaneously and required a delayed tympanoplasty procedure, which was 100% successful in sealing the perforation. These patients underwent a Type I tympanoplasty using an endaural approach and a temporalis fascia graft in four cases and a tragal cartilage graft in two cases. There was no associated ossicular lesion. The mean time between the explosion and surgery was 15.2 mo (range 5–35 mo). One patient required further surgery for an acquired cholesteatoma. Table I. Comparison of Healed Tympanic Membrane According to Control Time Points Group A (Spontaneous Closure Group) (n = 10) n (%) Group B (Biomembrane Patch Group) (n = 9) n (%) p-Value First month 2 (20) 8 (89) 0.005 Sixth month 4 (40) 9 (100) 0.011 Group A (Spontaneous Closure Group) (n = 10) n (%) Group B (Biomembrane Patch Group) (n = 9) n (%) p-Value First month 2 (20) 8 (89) 0.005 Sixth month 4 (40) 9 (100) 0.011 Table I. Comparison of Healed Tympanic Membrane According to Control Time Points Group A (Spontaneous Closure Group) (n = 10) n (%) Group B (Biomembrane Patch Group) (n = 9) n (%) p-Value First month 2 (20) 8 (89) 0.005 Sixth month 4 (40) 9 (100) 0.011 Group A (Spontaneous Closure Group) (n = 10) n (%) Group B (Biomembrane Patch Group) (n = 9) n (%) p-Value First month 2 (20) 8 (89) 0.005 Sixth month 4 (40) 9 (100) 0.011 The most frequently reported functional signs were tinnitus (n = 19; 100%) and hearing loss (n = 19; 100%). The initial post-blast audiometric data demonstrated mixed hearing loss in 52.6% (n = 10) of patients and pure conductive hearing loss in 47.3% of patients (n = 9). There was no significant recovery of sensorineural hearing loss at 1 mo. Air conduction and air-bone gap improved significantly in both groups. The mean audiometric air-bone gap was significantly lower in group B than group A at 1 mo (Fig. 2) (0.6 dB ± 0.28 vs. 16.2 dB ± 2.2; p < 0.0001). FIGURE 2. View largeDownload slide Comparison of mean hearing loss in terms of audiometric air-bone gap (decibels) at 1 mo according to group. FIGURE 2. View largeDownload slide Comparison of mean hearing loss in terms of audiometric air-bone gap (decibels) at 1 mo according to group. Differences between the two groups in tympanic perforation size, initial hearing loss, and initial medical management on the battlefield were not statistically significant. No evidence of poor tolerance or perioperative complications with the biomembrane was reported. DISCUSSION Blast injury of the ear causing tympanic perforation may complicate the initial management of war-wounded patients and affect their fitness to serve remotely. Blast wave positive pressure causes the entrance of epidermal debris and foreign objects into the middle ear, and almost systematically reverses the edges of the perforation, which creates a major risk of post-traumatic cholesteatoma.3,12 Blast-injured patients often exhibit associated polytrauma and require intensive initial management, which occurred in our series (85.7%; n = 12). These patients require prophylaxis to prevent bacterial growth in highly contaminated tissues that results from trauma-related infections in battlefield casualties.13,14 Early membrane perforation healing prevents middle ear infection, which could complicate the initial management of these patients. Spontaneous healing is primarily dependent on the size of the perforation, and no spontaneous closures were found for perforations that encompassed greater than 80% of the tympanic surface.6–8 These early and remote risks justify early management to improve tympanic perforation healing.3 A review of the literature suggests the use of a “patch” that guards and protects against tympanic scarring of the middle ear. Many materials were used for patching, and no significant differences in the technical success of tympanic membrane perforation closure were reported (e.g., paper, silk patch, gel-foam, micropore strip, alloderm, and water-soluble chitosan tape).15–18 Hyaluronic acid was initially used in middle ear surgery to improve the natural healing process in the mastoid cavity following tympanoplasty and reduce connective tissue formation. This material exhibits good biocompatibility.19,20 The outcomes of patching for tympanic perforation healing remain controversial. Some authors report no significant effect,21 and other authors demonstrated superiority compared to spontaneous healing of acute tympanic membrane perforation. Sayin et al reported an earlier closure time, but not a higher closure rate, with the use of hyaluronic acid ester patching (Epifilm) vs. spontaneous closure in traumatic tympanic membrane perforation.15 Patients with early myringoplasty in our series exhibited earlier tympanic closure times and higher closure rates. This procedure approximates the perforation edges, which prevents the inversion of the edges towards the inner mucosal side and acts as a scaffold for the regenerating squamous epithelium.12,22 This procedure also plays a role in fibrous layer healing and prevents dehydration of the epithelial margins. Güneri et al also demonstrated a positive effect of topical hyaluronic acid administration in acute tympanic membrane perforations.22 This surgery may allow for safer recovery of military activity because of the improvements in tympanic closure time and rate. Army legislation and the follow-up of these findings determine fitness to serve.23 The general habit was to declare patients fit to serve with waivers (e.g., prohibitions on swimming, diving, etc.) or unfit to serve until healing of the tympanic perforation. Early tympanoplasty using a biomembrane allowed the issuing of declarations of fitness to serve as soon as 1 mo post-surgery in our series. Early air-bone gap closure was achieved using early myringoplasty in our series, which is important in recovering fitness to serve. This fast and minimally invasive myringoplasty requires no dedicated surgery. Twelve patients in our series underwent early patching under general anesthesia in a perioperative setting during a damage control surgery for hemorrhagic trauma. The two patients who underwent patching under local anesthesia did not tolerate the procedure very well. They reported transient dizziness, a transient increase in tinnitus and earache, which was explained by the immediate post-traumatic context, with immediate and intense otological functional signs. CONCLUSION Blast injuries of the ear are characterized by large tympanic perforation, which is a risk factor for spontaneous closure failure. Early myringoplasty using a biomembrane is a fast and minimally invasive method of obtaining early closure of blast injury-induced large tympanic perforation. It can be performed under general anesthesia concurrently with surgery for additional body-wide trauma. The early closure rate and closure time avoid the immediate infectious risk, which potentially complicates the initial management of these war-wounded patients and auditory status and post-traumatic cholesteatoma risk remotely. This procedure may allow for safe and early recovery of military activity. The deployment of ENT surgeons on the battlefield in the French Army has enabled early management of these patients. REFERENCES 1 Ritenour AZ, Blackbourne LH, Kelly JF, et al. : Incidence of primary blast injury in US military overseas contingency operations: a retrospective study. Ann Surg 2010; 251( 6): 1140– 4. Google Scholar CrossRef Search ADS PubMed 2 Hoffmann C: French War-Wounded in Afghanistan – From Injury to Rehabilitation. Retrospective Epidemiological Study of a Cohort of 450 Patients Between 2010 and 2012. Preliminary Results [University Doctoral Thesis, Medicine] . Paris, Pierre et Marie Curie Paris VI University, 2014. http://www.sudoc.fr/185849113; accessed July 25, 2015. 3 Ballivet de Régloix S, Crambert A, Maurin O, Lisan Q, Marty S, Pons Y: Blast injury of the ear by massive explosion: a review of 41 cases. J R Army Med Corps 2017; 163( 5): 333– 8. Google Scholar CrossRef Search ADS PubMed 4 Peters P: Primary blast injury: an intact tympanic membrane does not indicate the lack of a pulmonary blast injury. Mil Med 2011; 176( 1): 110– 4. Google Scholar CrossRef Search ADS PubMed 5 Rosenfeld JV, Ford NL: Bomb blast, mild traumatic brain injury and psychiatric morbidity: a review. Injury 2010; 41( 5): 437– 43. Google Scholar CrossRef Search ADS PubMed 6 Pahor AL: The ENT problems following the Birmingham bombings. J Laryngol Otol 1981; 95( 4): 399– 406. Google Scholar CrossRef Search ADS PubMed 7 Ritenour AE, Wickley A, Ritenour JS, et al. : Tympanic membrane perforation and hearing loss from blast overpressure in Operation Enduring Freedom and Operation Iraqi Freedom wounded. J Trauma 2008; 64: S174– 8. Google Scholar CrossRef Search ADS PubMed 8 Miller IS, McGahey D, Law K: The otologic consequences of the Omagh bomb disaster. Otolaryngol Head Neck Surg 2002; 126( 2): 127– 8. Google Scholar CrossRef Search ADS PubMed 9 North Atlantic Treaty Organization. NATO: Chapter 16: medical support. In: NATO Logistic Handbook , Ed 3, pp 1610– 14. Brussels, 1997. http://www.nato.int/docu/logi-en/1997/lo-1610.htm. accessed July 25, 2015. 10 Poncet JL, Cudennec YF, Diard JP, Rondet P, Buffe P: Tympanoplasty in the treatment of sequelae of blast injuries of the ear. Ann Otolaryngol Chir Cervicofac 1990; 107( 6): 366– 70. Google Scholar PubMed 11 Cudennec YF, Lory D, Poncet JL, et al. : Blast injuries of the ear. Current status and study of 200 cases. Ann Otolaryngol Chir Cervicofac 1986; 103( 5): 335– 41. Google Scholar PubMed 12 Buffe P, Cudennec Y, Poncet JL: The effects of blast on the ear. Evolution of lesions and sequelae. Rev Med Aeronaut 2010; 31( 121): 38– 41. 13 Mérens A, Rapp C, Delaune D, Danis J, Berger F, Michel R: Prevention of combat-related infections: antimicrobial therapy in battlefield and barrier measures in French military medical treatment facilities. Travel Med Infect Dis 2014; 12( 4): 318– 29. Google Scholar CrossRef Search ADS PubMed 14 Buyten J, Kaufman G, Ryan M: Effects of ciprofloxacin/dexamethasone and ofloxacin on tympanic membrane perforation healing. Otol Neurotol 2007; 28( 7): 887– 90. Google Scholar CrossRef Search ADS 15 Sayin I, Kaya KH, Ekizoglu O, Erdim I, Kayhan FT: A prospective controlled trial comparing spontaneous closure and Epifilm patching in traumatic tympanic membrane perforations. Eur Arch Otorhinolaryngol 2013; 270( 11): 2857– 63. Google Scholar CrossRef Search ADS PubMed 16 Lou ZC, He JG: 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; 36( 3): 221– 6. Google Scholar CrossRef Search ADS PubMed 17 Kim J, Kim CH, Park CH, et al. : Comparison of methods for the repair of acute tympanic membrane perforations: Silk patch vs. paper patch. Wound Repair Regen 2010; 18( 1): 132– 8. Google Scholar CrossRef Search ADS PubMed 18 Park MK, Kim KH, Lee JD, Lee BD: Repair of large traumatic tympanic membrane perforation with a Steri-Strips patch. Otolaryngol Head Neck Surg 2011; 145( 4): 581– 5. Google Scholar CrossRef Search ADS PubMed 19 Laurent C, Hellstrom S, Stenfors L: Hyaluronic acid reduces connective tissue formation in middle ears filled with absorbable gelatin sponge: an experimental study. Am J Otolaryngol 1986; 7: 181– 86. Google Scholar CrossRef Search ADS PubMed 20 Park AH, Hughes CW, Jackson A, et al. : Crosslinked hydrogels for tympanic membrane repair. Otolaryngol Head Neck Surg 2006; 135( 6): 877– 83. Google Scholar CrossRef Search ADS PubMed 21 Conoyer JM, Kaylie DM, Jackson CG: Otologic surgery following ear trauma. Otolaryngol Head Neck Surg 2007; 137( 5): 757– 61. Google Scholar CrossRef Search ADS PubMed 22 Güneri EA, Tekin S, Yilmaz O, et al. : The effects of hyaluronic acid, epidermal growth factor, and mitomycin in an experimental model of acute traumatic tympanic membrane perforation. Otol Neurotol 2003; 24( 3): 371– 6. Google Scholar CrossRef Search ADS PubMed 23 Direction Centrale du Service de Santé des Armées: bureau aptitude médicale et expertise. Instruction n°2100/DEF/DCSSA/AST/AME relative à la détermination de l'aptitude médicale à servir. 2003. Paris: Direction Centrale du Service de Santé des Armées; 2003. 125p: 49– 52. Author notes The views expressed are solely those of the authors and do not reflect the official policy or position of the French Army, the Department of Defense, or the French Government. © Association of Military Surgeons of the United States 2018. All rights reserved. For permissions, please e-mail: email@example.com. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/about_us/legal/notices)
Military Medicine – Oxford University Press
Published: Apr 4, 2018
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