Chronic suppurative otitis media.

Chronic suppurative otitis media (CSOM) is a leading global cause of potentially preventable hearing loss in children and adults, associated with socioeconomic deprivation. There is an absence of consensus on the definition of CSOM, which complicates efforts for prevention, treatment, and monitoring. CSOM occurs when perforation of the tympanic membrane is associated with severe or persistent inflammation in the middle ear, leading to hearing loss and recurrent or persistent ear discharge (otorrhoea). Cholesteatoma, caused by the inward growth of the squamous epithelium of the tympanic membrane into the middle ear, can also occur. The optimal treatment of discharge in CSOM is topical antibiotics. In resource-limited settings where topical antibiotics might not be available, topical antiseptics are an alternative. For persistent disease, surgery to repair the tympanic membrane or remove cholesteatoma might offer long-term resolution of otorrhoea and potential improvement to hearing. Recent developments in self-fitted air-conduction and bone-conduction hearing aids offer promise as new options for rehabilitation.

Additional cartilage reinforcement of the annulus in myringoplasty for subtotal perforation.

OBJECTIVE: In this study, graft success, hearing outcome, and complications were compared following the repair of subtotal perforation using a cartilage reinforcement underlay technique (CRUT) versus the traditional cartilage underlay technique (TCUT). STUDY DESIGN: Randomized controlled trial. MATERIALS AND METHODS: Seventy-six patients with subtotal perforations were prospectively randomized to the CRUT (n = 38) or TCUT (n = 38) group. The graft success rate, hearing outcome, and complications were compared at 12 months. RESULTS: The mean operation time was 32.9 ± 4.2 (range: 26-47) min in the CRUT group and 51.8 ± 6.3 (range: 48-73) min in the TCUT group (P < 0.001). At 12 months postoperatively, no residual perforation was seen in either group. The graft success rate was 94.7 % (36/38) in the CRUT group and 92.1 % (35/38) in the TCUT group; the difference was not significant (P = 0.643). The postoperative air bone gap (ABG) was significantly improved compared to the preoperative value in both groups, without significant between-group differences in either the preoperative (P = 0.741) or postoperative (P = 0.865) ABG or the mean ABG gain (P = 0.812). Additionally, there were no significant between-group differences in the preoperative (P = 0.887) or postoperative (P = 0.753) mean bone-conduction pure tone average. In the TCUT group, seven (18.4 %) patients developed temporary hypogeusia and two (5.3 %) had external auditory canal scarring. Graft cholesteatoma was not observed in either group. CONCLUSION: In the treatment of subtotal perforations, lateral reinforcement of the annulus with additional cartilage is simpler than traditional cartilage underlay for achieving graft and hearing success. The technique also does not involve raising the tympanomeatal flap or removing perforation margins.

Outcomes of endoscopic modified cartilage-perichondrium tympanoplasty on different sized perforations.

OBJECTIVES: To evaluate the anatomic and functional outcomes of type1 tympanoplasty with endoscopic modified butterfly cartilage-perichondrium technique. METHODS: In our modification, perichondrium was elevated circumferentially till the attached part of the composite graft was approximately same size and shape of the perforation, cartilage was trimmed based on the perforation but 0.5 mm larger. Cartilage portion of the graft was placed medial to the edge of the perforation, then perichondrium was rolled out and draped on the circumferential raw surface of remaining tympanic membrane around. RESULTS: At 4 months postop, the anatomic integrity rate of the tympanic membrane perforation for small & medium sized perforation and large sized perforation group were 100 % and 94 % (p > 0.05). For the small & medium perforation group, the mean pre and 4 months postop ACs were 30 ± 8 dB and 18 ± 6.4 dB (p < 0.01). The mean pre and 4 months postop ABGs were 19 ± 11 dB and 9 ± 3 dB (p < 0.01). For the large perforation group, the mean pre and 4 months postop ACs were 43 ± 12.5 dB and 21.5 ± 7 dB (p < 0.01). The mean pre and 4 months postop ABGs were 34 ± 8.5 dB and 12.5 ± 6 dB (p < 0.01). The differences of mean 4 months postop ACs and mean 4 months postop ABGs between the two groups were not significant (p > 0.05). CONCLUSIONS: Compared to the conventional inlay butterfly cartilage tympanoplasty technique, large or marginal perforations can be sealed more securely by this modification.

Preliminary investigation of endoscopic surgery for tympanic membrane perforation: Regenerative treatment compared with conventional surgery.

PURPOSE: To compare surgical outcomes of regenerative treatment (RT) including basic fibroblast growth factor (bFGF) (Group-R) with the conventional method (Group-C) for patients with tympanic membrane perforation (TMP), both of whom underwent transcanal endoscopic ear surgery. METHODS: The study population of Group-R included 61 ears of 59 patients treated with RT-TMP in which TMP edges were disrupted mechanically and a gelatin sponge immersed in bFGF was inserted into the TMP. Fibrin glue was then dripped over the sponge. Group-C consisted of 13 patients who underwent conventional surgery before adopting the RT-TMP. Patients' characteristics and outcomes including TMP closure rates, and change in hearing level were evaluated three or more weeks after the surgery. RESULTS: The baseline characteristics including size of TMP were not significantly different between the two groups. Although Group-R had significantly shorter operating time than Group-C, the complete TMP closure rates were 69 % (9/13) and 85 % (52/61), respectively. Air-conduction hearing thresholds showed significant improvements, and analysis of variance showed that Group-R achieved significant interactions other than at 8 kHz, implying better improvement in cases with TMP closure. The air-bone gaps also improved at all frequencies in both groups. Specifically, at 4 kHz, there was a trend showing better improvement in Group-R. CONCLUSION: RT-TMP had a high TMP closure rate and good hearing improvement, with no significant differences compared with those of conventional surgery. This new therapy is simple and safe, and requires less operating time, and it could help improve the quality of life of patients with TMP.

Outcomes of perichondrium graft covering the epithelium of the tympanic membrane for large-sized perforations: A 3-5-year follow-up study.

OBJECTIVE: The objective of this study was to evaluate the graft outcomes and iatrogenic cholesteatomas for 3 years following cartilage-perichondrium over-underlay technique with perichondrial graft covering the epithelium for large-sized tympanic membrane (TM) perforations. MATERIALS AND METHODS: This prospective case series enrolled patients with large-sized perforation who underwent endoscopic cartilage-perichondrium over-underlay technique. The graft success rate, hearing outcomes, and development of iatrogenic middle ear cholesteatomas and graft cholesteatomas were assessed at 3 years postoperatively. RESULTS: This study included 62 ears of 62 patients. The mean follow-up duration was 47.3 ± 10.8 (38-64) months. Neovascularization was observed in the lateral perichondrium graft in 55 (88.7 %) patients, which inosculated into the TM remnant at 4-5 weeks. However, graft neovascularization was not observed in the four patients with excessive perichondrium graft that migrated into the external auditory canal and the three patients with middle ear infections. The graft failure rate was 6.5 % at 6 months, 11.3 % at 12 months, 6.5 % at 24 months, and the overall graft success rate was 91.8 % at the last follow-up. Granular myringitis developed in 11.3 % (7/62) of the patients. High-resolution computed tomography revealed well-pneumatized mastoids and middle ear at the final follow-up. However, graft cholesteatomas were observed in 3 (4.8 %) patients at 7-24 months postoperatively. CONCLUSIONS: The cartilage-perichondrium over-underlay technique with perichondrial graft covering TM epithelium is safe and effective for the repair of large perforations, with good short- and long-term graft outcomes, minimal risk of graft cholesteatoma development, and no risk of iatrogenic middle ear cholesteatomas.

A comparative study of endoscopic myringoplasty versus microscopic myringoplasty at tertiary care center.

BACKGROUND AND OBJECTIVES: Myringoplasty is a surgical procedure performed to repair tympanic membrane perforation which can be performed either using a microscope or an endoscope. The aim of this study is to compare the graft uptake, hearing outcome and operative time of endoscopic myringoplasty (EM) versus microscopic myringoplasty (MM) by underlay cartilage island graft technique. SUBJECTS AND METHODS: In this prospective comparative study of sixty patients divided into two equal groups with small to medium sized tympanic membrane perforation were included. Tragal cartilage was used as graft material. Both the groups underwent myringoplasty by underlay cartilage island graft using endoscope (n = 30) and microscope (n = 30). The study was conducted between February 2022 to May 2023 after taking ethical approval from IRC of Nepalese Army Institute of Health Sciences. All patients were followed up on 7th postoperative day (POD), 1 and 3 months after surgery. RESULTS: Graft uptake in was 90 % (27/30) in MM group and 93.33 % (28/30) in EM group. Mean operating time was more in MM group (66.46 ± 6.78min) than EM group (64.53 ± 6.6 min). The improvement in Air Bone Gap (ABG) was better in EM group (12.46 ± 6.58 dB) compared to MM group (10.9 ± 9.01 dB). The differences in graft uptake, operating time and improvement in ABG were not statistically significant. CONCLUSION: The study concludes that it does not matter which approach is used, good results are predictable and choice of the tool used is up to the individual surgeon.

Comparison of temporalis fascia and cartilage graft over-under myringoplasty for repairing large perforations.

OBJECTIVE: The objective of this study was to compare the operation time, graft success, audiometric outcomes and complications of over-under technique using a temporalis fascia (TMF) and cartilage grafts for the repair of large perforations. STUDY DESIGN: Randomized controlled trial. MATERIALS AND METHODS: 80 large perforations >2 quadrants of eardrum were prospectively randomized to undergo TMF over-under technique group (TFON, n = 40) or cartilage-perichondrium over-under technique group (CPON, n = 40). The graft success rate, audiometric outcomes, and complications were compared among two groups at 12 months. RESULTS: The mean operation time was 56.8 ± 4.2 (range:52-71) min in the TFON group and 37.9 ± 2.8 (range: 31-47) min in the CPON group (P < 0.001). The lost follow-up rate was 3 (7.5 %) patients in the TFON group and 2 (5.0 %) patient in the CPON group (P = 0.644). Finally, 37 patients in the TFON group and 38 patients in the CPON group were included in this study. The graft infection rate was 2 (5.4 %) patients in the TFON group and 2 (5.3 %) patient in the CPON group (P = 0.626), all the graft infection resulted in the residual perforation. The remaining residual perforation was 2 (5.4 %) patients in the TFON group and 1 (2.6 %) patient in the CPON group; the re-perforation was 3 (8.1 %) patients in the TFON group and 0 (0.0 %) patient in the CPON group. The graft success rate was 81.1 % (30/37) patients in the TFON group and 92.1 % (35/38) patient in the CPON group. The mean preoperative and 12-month postoperative ABGs were significantly different in any group (P < 0.01). However, there were no significant difference among two groups regardless of pre-or post-ABGs or ABG closure. No lateralization of the graft or blunting was noted in any group. Four (10.8 %)patients developed atelectasis and one (2.7 %) developed the EAC scarring in the TFON group. Graft cholesteatomas was found in 2 (5.4 %) patients in the TFON group and in 5 (13.2 %) patients in the CPON group (P = 0.449). Three (8.1 %) patients had temporary hypogeusia in the TFON group. CONCLUSION: Although temporalis fascia graft over-under technique obtained similar graft success rates and hearing outcomes for large chronic perforations to the cartilage-perichondrium over-under technique, temporalis fascia graft technique prolonged the operation time and increased the re-perforation and graft atelectasis. Nevertheless, the graft cholesteatomas were comparable among two techniques.

Comparison of two endoscopic perichondrium-cartilage graft underlay myringoplasty for large perforations: a randomized controlled trial.

OBJECTIVE: The objective of this study was to compare the graft outcomes and complications of two endoscopic perichondrium-cartilage graft techniques for repairing large perforations. STUDY DESIGN: Single center blinded randomized controlled trial. MATERIALS AND METHODS: 61 large perforations more than 50% of TM area were prospectively randomized to undergo the free perichondrium and free cartilage graft group (FPFC, n = 31) or perichondrium partial attachment the cartilage graft group (PPAC, n = 30). The primary outcome measures were the operation time; secondary outcome measures were the graft success rate and hearing gain at 12 months postoperatively and postoperative complications. RESULTS: All patients completed follow-up of 12 months. The mean operation time was 38.2 ± 2.3 min in the FPFC group and 37.4 ± 5.6 min in the PPAC group (P = 0.658). At postoperative 3 months, the graft success rates were 96.7% in the FPFC group and 93.3% in the PPAC group (P = 0.976). At postoperative 12 months, the graft success rates were 96.7% in the FPFC group and 83.3% in the PPAC group (P = 0.182). However, the residual and re-perforation rate with no infection was 0.0% (0/31) in the FPFC group and 16.7% (5/30) in the PPAC group (P = 0.056). No significant between-group differences were observed pre- (P = 0.842) or post- (P = 0.759) operative air bone gap (ABG) values or mean ABG gain (P = 0.886). However, granular myringitis has been noted in 6.5% in the FPFC group and in 3.3% in the PPAC group. CONCLUSIONS: This study suggested that 12-month graft success and hearing gain were comparable between the perichondrium free and partial attachment the cartilage graft techniques, nevertheless, partial attachment technique could increase residual and re-perforations.

A systematic review of otologic injuries sustained in civilian terrorist explosions.

PURPOSE: Determine the prevalence of otological symptoms and tympanic membrane perforation, healing rates of tympanic membrane perforation with surgical and conservative management, and hearing function in civilian victims of terrorist explosions. METHODS: A systematic review was conducted with searches on Medline, Embase, EMCare and CINAHL for publications between the 1st January 1945 and 26th May 2023. Studies with quantitative data addressing our aims were included. This review is registered with PROSPERO: CRD42020166768. Among 2611 studies screened, 18 studies comprising prospective and retrospective cohort studies were included. RESULTS: The percentage of eardrums perforated in patients admitted to hospital, under ENT follow up and attending the emergency department is 69.0% (CI 55.5-80.5%), 38.7% (CI 19.0-63.0%, I2 0.715%) and 21.0% (CI 11.9-34.3%, I2 0.718%) respectively. Perforated eardrums heal spontaneously in 62.9% (CI 50.4-73.8%, I2 0.687%) of cases and in 88.8% (CI 75.9-96.3%, I2 0.500%) of cases after surgery. Common symptoms present within one month of bombings are tinnitus 84.7% (CI 70.0-92.9%, I2 0.506%), hearing loss 83.0% (CI 64.5-92.9%, I2 0.505%) and ear fullness 59.7% (CI 13.4-93.4%, I2 0.719). Symptomatic status between one and six months commonly include no symptoms 57.5% (CI 46.0-68.3%), hearing loss 35.4% (CI 21.8-51.8%, I2 0.673%) and tinnitus 15.6% (CI 4.9-40.0%, I2 0.500%). Within one month of bombings, the most common hearing abnormality is sensorineural hearing loss affecting 26.9% (CI 16.9-40.1%, I2 0.689%) of ears 43.5% (CI 33.4-54.2%, I2 0.500) of people. CONCLUSION: Tympanic membrane perforation, subjective hearing loss, tinnitus, ear fullness and sensorineural hearing loss are common sequelae of civilian terrorist explosions.

Comparison of endoscope-assisted and microscope-assisted type I tympanoplasty; a systematic review and meta-analysis.

OBJECTIVES: To analyze and compare the available data about the outcomes of endoscopic and microscopic type I tympanoplasty. DATA SOURCES: PubMed, Cochrane library Ovid, Scopus, Google scholar, and ClinicalTrials. METHODS: We conducted a meta-analysis in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. We included comparative studies describing type I tympanoplasty, and comparing surgical outcomes of the endoscope with the microscope in terms of efficacy and safety. RESULTS: Our systematic search yielded 22 studies meeting the inclusion criteria and eligible for analysis. The pooled graft uptake rates and audiological results of endoscopic and microscopic tympanoplasty demonstrated non-significant differences. In contrast, endoscopic type I tympanoplasty outperforms microscopic tympanoplasty regarding a highly significant decrease not only in pooled mean operative time but also in the pooled complications rate. CONCLUSIONS: Based on our meta-analysis, the surgical outcomes of endoscope-assisted and microscope-assisted type I tympanoplasty in terms of postoperative hearing outcomes and the graft uptake rate were comparable. On the contrary, operative time and complications rate proved to be significantly reduced with endoscopy compared to microscopy. Hence, the endoscope is as efficient as the microscope in type I tympanoplasty but less invasive, fewer in complications and shorter in operative time.

To detach or not to detach the umbo in type I tympanoplasty: functional results.

PURPOSE: To compare the audiological outcomes, tympanic membrane (TM) healing rates and complication rates in patients undergoing endoscopic underlay and over-under tympanoplasty type I (TTI). METHODS: The study includes 95 patients who underwent endoscopic TTI in the period between 2018 and 2023: 56% of the patients had the underlay technique and 41% had the over-under technique. Data regarding pre- and postoperative hearing, perforation characteristics, surgical procedures, graft types and complications were retrospectively analyzed. Audiometrical assessment included air conduction (AC) and bone conduction (BC) pure tone averages (PTA) and air-bone gap (ABG), pre- and postoperatively. RESULTS: Both underlay and over-under techniques significant improved AC PTA, with a mean ABG improvements of 5.9 dB and 7.2 dB, respectively. There was no significant difference in BC PTA between pre- and post-operative, indicating no inner ear damage in both techniques. The over-under technique showed a significantly higher TM closure rate (94.4%) compared to the underlay technique (80.6%). Complications were rare, with only one case of TM lateralization requiring revision surgery. CONCLUSIONS: Endoscopic TTI is an effective treatment in improving auditory function in chronic middle ear diseases. In our cohort, the detachment of the umbo does not negatively influence the postoperative hearing results and does not increase rate of complications. Moreover, the over-under technique demonstrates superior TM closure rates, making it a valuable option for specific cases. However, future prospective studies with larger sample sizes and longer term follow-up are needed to validate these findings and provide more comprehensive insights.

Tympanic membrane perforations cannot be reliably detected using computed tomography based on 15 cadaver dogs.

The integrity of the tympanic membrane is an important factor when deciding treatment and therapeutic recommendations for dogs with ear disease; however, otoscopic examination may be difficult to perform due to features of external ear canal disease or patient compliance. CT is useful for the evaluation of middle ear disease, including cases in which middle ear disease is detected incidentally. The tympanic membrane is detectable using CT, but anecdotally, apparent focal defects or discontinuities of the tympanic membrane are often seen in patients with and without ear disease. The purpose of this prospective, observer agreement study was to determine if perforations of the tympanic membrane are reliably detectable on CT. Fifteen cadaver dogs underwent CT and video otoscopy to verify the integrity of each tympanic membrane. Cadavers were randomly assigned to have the tympanic membranes left intact or to undergo a myringotomy on either the left, the right, or both sides. CT was performed immediately following the myringotomies. Four blinded evaluators evaluated the pre- and post-myringotomy scans for a total of 30 scans (60 tympanic membranes). Average accuracy was low (44%), and interobserver agreement for all four evaluators was fair. Although the tympanic membrane is visible on CT, perforations of the tympanic membrane are unlikely to be accurately detected or excluded. The appearance of an intact tympanic membrane or defect in the membrane on CT should not be used as criteria to guide clinical treatment recommendations based on this cadaver model.

Sometimes less is more: experience with endoscopic myringoplasty.

A retrospective review of the outcomes of patients who underwent endoscopic myringoplasties in our institution was conducted. The aim was to highlight our results with this procedure. The database of patient records was manually checked, and the patients who had undergone Endoscopic Myringoplasties were identified, and their demographics, admitting notes, operating notes, and discharge summaries were reviewed. Graft failure was considered if the patient had a perforation in the graft during the outpatient follow-up. The information was compiled, and basic statistics were derived. A total of 31 patients were identified who had undergone Endoscopic Myringoplasty. Patients' age ranged from 14-52 years. None of the patients developed any immediate postoperative complications. Follow-up otoscopic examination showed 28 patients with an intact graft and only one patient with graft failure. Two patients were lost to follow up. Our success rate with Endoscopic Myringoplasty is 96.6%, which is comparable to the international standard success rate of 80-95%. The results of this study encourage adopting an endoscopic approach where the expertise is available.

Does the Location of a Small Tympanic Membrane Perforation Affect the Degree of Hearing Loss in Adult Patients with Inactive Mucosal Chronic Suppurative Otitis Media?

BACKGROUND: Tympanic membrane perforation due to inactive mucosal chronic suppurative otitis media is a common problem in otolaryngology, with consequent conductive hearing loss. Still, there is controversy about the relationship between the location of the tympanic membrane perforation and the degree of hearing impairment. AIM OF THE STUDY: To assess the correlation between the location of a small tympanic membrane perforation and the degree of conductive hearing loss in adult patients with inactive mucosal chronic suppurative otitis media. PATIENTS AND METHODS: A prospective cross-sectional study enrolled 74 adult patients with small tympanic membrane perforations (perforation involves less than one quadrant of the tympanic membrane) and conductive hearing loss (airbone gap ≥ 20 dB HL) due to inactive mucosal chronic suppurative otitis media for at least 3 months. The locations of the tympanic membrane perforations were classified as anterosuperior, anteroinferior, posterosuperior, and poster inferior perforations. Audiometric analysis and a CT scan of the temporal bone were done for all patients. The means of the air and bone conduction pure tone hearing threshold averages at frequencies 500, 1000, 2000, and 4000 Hz were calculated, and consequently, the air-bone gaps were calculated and presented as means. The ANOVA test was used to compare the means of the air-bone gaps, and the Scheffe test was used to determine if there were statistically significant differences regarding the degree of conductive hearing loss in relation to different locations of the tympanic membrane perforation. RESULTS: The ages of the patients ranged from 20 to 43 years (mean = 31.9 ± 6.5 years), of whom 43 (58%) were females and 31 (42%) were males. The means of the air-bone gaps were 32.29 ± 5.41 dB HL, 31.34 ± 4.12 dB HL, 29.87 ± 3.48 dB HL, and 29.30 ± 4.60 dB HL in the posteroinferior, posterosuperior, anteroinferior, and anterosuperior perforations, respectively. Although the air-bone gap's mean was greater in the posteroinferior perforation, statistical analysis showed that it was insignificant (P-value=0.168). CONCLUSION: In adult patients with inactive chronic suppurative otitis media, the anteroinferior quadrant is the most common location of the tympanic membrane perforation, and there was an insignificant correlation between the location of a small tympanic membrane perforation and the degree of conductive hearing loss.

Antibiotics for acute otitis media in children.

BACKGROUND: Acute otitis media (AOM) is one of the most common diseases in childhood for which antibiotics are commonly prescribed; a systematic review reported a pooled prevalence of 85.6% in high-income countries. This is an update of a Cochrane Review first published in the Cochrane Library in 1997 and updated in 1999, 2005, 2009, 2013 and 2015. OBJECTIVES: To assess the effects of antibiotics for children with AOM. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Current Contents, CINAHL, LILACS and two trial registers. The date of the search was 14 February 2023. SELECTION CRITERIA: We included randomised controlled trials comparing 1) antimicrobial drugs with placebo, and 2) immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with AOM. DATA COLLECTION AND ANALYSIS: Two review authors independently screened trials for inclusion and extracted data using the standard methodological procedures recommended by Cochrane. Our primary outcomes were: 1) pain at various time points (24 hours, two to three days, four to seven days, 10 to 14 days), and 2) adverse effects likely to be related to the use of antibiotics. Secondary outcomes were: 1) abnormal tympanometry findings, 2) tympanic membrane perforation, 3) contralateral otitis (in unilateral cases), 4) AOM recurrences, 5) serious complications related to AOM and 6) long-term effects (including the number of parent-reported AOM symptom episodes, antibiotic prescriptions and health care utilisation as assessed at least one year after randomisation). We used the GRADE approach to rate the overall certainty of evidence for each outcome of interest. MAIN RESULTS: Antibiotics versus placebo We included 13 trials (3401 children and 3938 AOM episodes) from high-income countries, which we assessed at generally low risk of bias. Antibiotics do not reduce pain at 24 hours (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.78 to 1.01; 5 trials, 1394 children; high-certainty evidence), or at four to seven days (RR 0.76, 95% CI 0.50 to 1.14; 7 trials, 1264 children), but result in almost a third fewer children having pain at two to three days (RR 0.71, 95% CI 0.58 to 0.88; number needed to treat for an additional beneficial outcome (NNTB) 20; 7 trials, 2320 children; high-certainty evidence), and likely result in two-thirds fewer having pain at 10 to 12 days (RR 0.33, 95% CI 0.17 to 0.66; NNTB 7; 1 trial, 278 children; moderate-certainty evidence). Antibiotics increase the risk of adverse events such as vomiting, diarrhoea or rash (RR 1.38, 95% CI 1.16 to 1.63; number needed to treat for an additional harmful outcome (NNTH) 14; 8 trials, 2107 children; high-certainty evidence). Antibiotics reduce the risk of children having abnormal tympanometry findings at two to four weeks (RR 0.83, 95% CI 0.72 to 0.96; NNTB 11; 7 trials, 2138 children), slightly reduce the risk of experiencing tympanic membrane perforations (RR 0.43, 95% CI 0.21 to 0.89; NNTB 33; 5 trials, 1075 children) and halve the risk of contralateral otitis episodes (RR 0.49, 95% CI 0.25 to 0.95; NNTB 11; 4 trials, 906 children). However, antibiotics do not reduce the risk of abnormal tympanometry findings at six to eight weeks (RR 0.89, 95% CI 0.70 to 1.13; 3 trials, 953 children) and at three months (RR 0.94, 95% CI 0.66 to 1.34; 3 trials, 809 children) or late AOM recurrences (RR 0.94, 95% CI 0.79 to 1.11; 6 trials, 2200 children). Severe complications were rare, and the evidence suggests that serious complications do not differ between children treated with either antibiotics or placebo. Immediate antibiotics versus expectant observation We included six trials (1556 children) from high-income countries. The evidence suggests that immediate antibiotics may result in a reduction of pain at two to three days (RR 0.53, 95% CI 0.35 to 0.79; NNTB 8; 1 trial, 396 children; low-certainty evidence), but probably do not reduce the risk of pain at three to seven days (RR 0.75, 95% CI 0.50 to 1.12; 4 trials, 959 children; moderate-certainty evidence), and may not reduce the risk of pain at 11 to 14 days (RR 0.91, 95% CI 0.75 to 1.10; 1 trial, 247 children; low-certainty evidence). Immediate antibiotics increase the risk of vomiting, diarrhoea or rash (RR 1.87, 95% CI 1.39 to 2.51; NNTH 10; 3 trials, 946 children; high-certainty evidence). Immediate antibiotics probably do not reduce the proportion of children with abnormal tympanometry findings at four weeks and evidence suggests that immediate antibiotics may not reduce the risk of tympanic membrane perforation and AOM recurrences. No serious complications occurred in either group. AUTHORS' CONCLUSIONS: This review reveals that antibiotics probably have no effect on pain at 24 hours, a slight effect on pain in the days following and only a modest effect on the number of children with tympanic perforations, contralateral otitis episodes and abnormal tympanometry findings at two to four weeks compared with placebo in children with AOM. In high-income countries, most cases of AOM spontaneously remit without complications. The benefits of antibiotics must be weighed against the possible harms: for every 14 children treated with antibiotics, one child experienced an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics were withheld. For most children with mild disease in high-income countries, an expectant observational approach seems justified. Therefore, clinical management should emphasise advice about adequate analgesia and the limited role for antibiotics.

Ventilation tubes (grommets) for otitis media with effusion (OME) in children.

BACKGROUND: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. It may cause hearing loss which, when persistent, may lead to developmental delay, social difficulty and poor quality of life. Management includes watchful waiting, autoinflation, medical and surgical treatment. Insertion of ventilation tubes has often been used as the preferred treatment. OBJECTIVES: To evaluate the effects (benefits and harms) of ventilation tubes (grommets) for OME in children. SEARCH METHODS: We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished trials on 20 January 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs in children (6 months to 12 years) with OME for ≥ 3 months. We included studies that compared ventilation tube (VT) insertion with five comparators: no treatment, watchful waiting (ventilation tubes inserted later, if required), myringotomy, hearing aids and other non-surgical treatments. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing; 2) OME-specific quality of life; 3) persistent tympanic membrane perforation (as a severe adverse effect of the surgery). Secondary outcomes were: 1) persistence of OME; 2) other adverse effects (including tympanosclerosis, VT blockage and pain); 3) receptive language skills; 4) speech development; 5) cognitive development; 6) psychosocial skills; 7) listening skills; 8) generic health-related quality of life; 9) parental stress; 10) vestibular function; 11) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for key outcomes. Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method, due to challenges in interpreting the results of mean hearing thresholds. MAIN RESULTS: We included 19 RCTs (2888 children). We considered most of the evidence to be very uncertain, due to wide confidence intervals for the effect estimates, few participants, and a risk of performance and detection bias. Here we report our key outcomes at the longest reported follow-up. There were some limitations to the evidence. No studies investigated the comparison of ventilation tubes versus hearing aids. We did not identify any data on disease-specific quality of life; however, many studies were conducted before the development of specific tools to assess this in otitis media. Short-acting ventilation tubes were used in most studies and thus specific data on the use of long-acting VTs is limited. Finally, we did not identify specific data on the effects of VTs in children at increased risk of OME (e.g. with craniofacial syndromes). Ventilation tubes versus no treatment (four studies) The odds ratio (OR) for a return to normal hearing after 12 months was 1.13 with VTs (95% confidence interval (CI) 0.46 to 2.74; 54% versus 51%; 1 study, 72 participants; very low-certainty evidence). At six months, VTs may lead to a large reduction in persistent OME (risk ratio (RR) 0.30, 95% CI 0.14 to 0.65; 20.4% versus 68.0%; 1 study, 54 participants; low-certainty evidence). The evidence is very uncertain about the chance of persistent tympanic membrane perforation with VTs at 12 months (OR 0.85, 95% CI 0.38 to 1.91; 8.3% versus 9.7%; 1 RCT, 144 participants). Early ventilation tubes versus watchful waiting (six studies) There was little to no difference in the proportion of children whose hearing returned to normal after 8 to 10 years (i.e. by the age of 9 to 13 years) (RR for VTs 0.98, 95% CI 0.94 to 1.03; 93% versus 95%; 1 study, 391 participants; very low-certainty evidence). VTs may also result in little to no difference in the risk of persistent OME after 18 months to 6 years (RR 1.21, 95% CI 0.84 to 1.74; 15% versus 12%; 3 studies, 584 participants; very low-certainty evidence). We were unable to pool data on persistent perforation. One study showed that VTs may increase the risk of perforation after a follow-up duration of 3.75 years (RR 3.65, 95% CI 0.41 to 32.38; 1 study, 391 participants; very low-certainty evidence) but the actual number of children who develop persistent perforation may be low, as demonstrated by another study (1.26%; 1 study, 635 ears; very low-certainty evidence). Ventilation tubes versus non-surgical treatment (one study) One study compared VTs to six months of antibiotics (sulphisoxazole). No data were available on return to normal hearing, but final hearing thresholds were reported. At four months, the mean difference was -5.98 dB HL lower (better) for those receiving VTs, but the evidence is very uncertain (95% CI -9.21 to -2.75; 1 study, 125 participants; very low-certainty evidence). No evidence was identified regarding persistent OME. VTs may result in a low risk of persistent perforation at 18 months of follow-up (no events reported; narrative synthesis of 1 study, 60 participants; low-certainty evidence). Ventilation tubes versus myringotomy (nine studies) We are uncertain whether VTs may slightly increase the likelihood of returning to normal hearing at 6 to 12 months, since the confidence intervals were wide and included the possibility of no effect (RR 1.22, 95% CI 0.59 to 2.53; 74% versus 64%; 2 studies, 132 participants; very low-certainty evidence). After six months, persistent OME may be reduced for those who receive VTs compared to laser myringotomy, but the evidence is very uncertain (OR 0.27, 95% CI 0.19 to 0.38; 1 study, 272 participants; very low-certainty evidence). At six months, the risk of persistent perforation is probably similar with the use of VTs or laser myringotomy (narrative synthesis of 6 studies, 581 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: There may be small short- and medium-term improvements in hearing and persistence of OME with VTs, but it is unclear whether these persist after longer follow-up. The RCTs included do not allow us to say when (or how much) VTs improve hearing in any specific child. However, interpretation of the evidence is difficult: many children in the control groups recover spontaneously or receive VTs during follow-up, VTs may block or extrude, and OME may recur. The limited evidence in this review also affects the generalisability/applicability of our findings to situations involving children with underlying conditions (e.g. craniofacial syndromes) or the use of long-acting tubes. Consequently, RCTs may not be the best way to determine whether an intervention is likely to be effective in any individual child. Instead, we must better understand the different OME phenotypes to target interventions to children who will benefit most, and avoid over-treating when spontaneous resolution is likely.

Decellularized tympanic membrane scaffold with bone marrow mesenchymal stem cells for repairing tympanic membrane perforation.

BACKGROUND: Tympanic membrane perforation (TMP) is a common disease in otology, and few acellular techniques have been reported for repairing this condition. Decellularized extracellular matrix (ECM) scaffolds have been used in organ reconstruction. OBJECTIVE: This study on tissue engineering aimed to develop a tympanic membrane (TM) scaffold prepared using detergent immersion and bone marrow mesenchymal stem cells (BMSCs) as repair materials to reconstruct the TM. RESULTS: General structure was observed that the decellularized TM scaffold with BMSCs retained the original intact anatomical ECM structure, with no cell residue, as observed using scanning electron microscopy (SEM), and exhibited low immunogenicity. Therefore, we seeded the decellularized TM scaffold with BMSCs for recellularization. Histology and eosin staining, SEM and immunofluorescence in vivo showed that the recellularized TM patch had a natural ultrastructure and was suitable for the migration and proliferation of BMSCs. The auditory brainstem response (ABR) evaluated after recellularized TM patch repair was slightly higher than that of the normal TM, but the difference was not significant. CONCLUSION: The synthetic ECM scaffold provides temporary physical support for the three-dimensional growth of cells during the tissue developmental stage. The scaffold stimulates cells to secrete their own ECM required for tissue regeneration. The recellularized TM patch shows potential as a natural, ultrastructure biological material for TM reconstruction.

The Dorsal Skinfold Chamber as a New Tympanic Membrane Wound Healing Model: Intravital Insights into the Pathophysiology of Epithelialized Wounds.

BACKGROUND: Tympanic membrane perforations (TMPs) are a common complication of trauma and infection. Persisting perforations result from the unique location of the tympanic membrane. The wound is surrounded by air of the middle ear and the external auditory canal. The inadequate wound bed, growth factor, and blood supply lead to circular epithelialization of the perforation's edge and premature interruption of defect closure. Orthotopic animal models use mechanical or chemical tympanic membrane laceration to identify bioactive wound dressings and overcome premature epithelialization. However, all orthotopic models essentially lack repetitive visualization of the biomaterial-wound interface. Therefore, recent progress in 3D printing of customized wound dressings has not yet been transferred to the unique wound setup of the TMP. Here, we present a novel application for the mice dorsal skinfold chamber (DSC) with an epithelialized full-thickness defect as TMP model. METHODS: A circular 2-mm defect was cut into the extended dorsal skinfold using a biopsy punch. The skinfold was either perforated through both skin layers without prior preparation or perforated on 1 side, following resection of the opposing skin layer. In both groups, the wound was sealed with a coverslip or left unclosed (n = 4). All animals were examined for epithelialization of the edge (histology), size of the perforation (planimetry), neovascularization (repetitive intravital fluorescence microscopy), and inflammation (immunohistology). RESULTS: The edge of the perforation was overgrown by the cornified squamous epithelium in all pre-parations. Reduction in the perforation's size was enhanced by application of a coverslip. Microsurgical preparation before biopsy punch perforation and sealing with a coverslip enabled repetitive high-quality intravital fluorescence microscopy. However, spontaneous reduction of the perforation occurred frequently. Therefore, the direct biopsy punch perforation without microsurgical preparation was favorable: spontaneous reduction did not occur throughout 21 days. Moreover, the visualization of the neovascularization was sufficient in intravital microscopy. CONCLUSIONS: The DSC full-thickness defect is a valuable supplement to orthotopic TMP models. Repetitive intravital microscopy of the epithelialized edge enables investigation of the underlying pathophysiology during the transition from the inflammation to the proliferation phase of wound healing. Using established analysis procedures, the present model provides an effective platform for the screening of bioactive materials and transferring progress in tissue engineering to the special conditions of tympanic membrane wound healing.

Otoendoscopic Tympanic Repair of Tympanic Perforations Secondary to Chronic Otitis Media Using Porcine Small-intestine Membrane.

Context: The most common cause of hearing loss is chronic otitis media. Patients often exhibit ear tightness, ear plugging, conductive hearing loss, and even secondary perforation of the tympanic membrane. Patients require antibiotics to improve symptoms, and some patients need surgical repair of the membrane. Objective: The study intended to examine the effects of two methods of surgical transplantation using porcine mesentery under an otoscope on the surgical outcomes of patients with tympanic-membrane perforation secondary to chronic otitis media, with the intent to provide a basis for clinical practice. Design: The research team conducted a retrospective case-controlled study. Setting: The study took place at the Sir Run Run Shaw Hospital of the College of Medicine at Zhejiang University in Hangzhou, Zhejiang, China. Participants: Participants were 120 patients with tympanic membrane perforations that were secondary to chronic otitis media who had been admitted to the hospital between December 2017 and July 2019. Intervention: The research team divided the participants into two groups according to the surgical indications for repair of their perforations: (1) for patients with the central type of perforations with a rich residual tympanic membrane, the surgeon used the internal implantation method, and (2) for patients with a marginal or central perforation with a low residual tympanic membrane, the surgeon used the interlayer implantation method. Both groups received the implantations under conventional microscopic tympanoplasty, and the Department of Otolaryngology Head & Neck Surgery at the hospital provided the porcine mesenteric material. Outcome Measures: The research team compared the differences between the groups in operation time, blood loss, changes in the level of hearing loss between baseline and postintervention, air-bone conductivity, treatment effects, and surgical complications. Results: The operation time and blood loss of the internal implantation group were significantly greater than those of interlayer implantation group (P < .05). At 12 months postintervention, one participant in the internal implantation group had perforation recurrence, and two participants in the interlayer implantation group had infections and two had perforation recurrence. No significant difference existed between the groups in the complication rate (P > .05). Conclusions: Endoscopic repair of tympanic membrane perforations that were secondary to chronic otitis media, using porcine mesentery as the material for implantation, is a reliable treatment with few complications and good postoperative hearing recovery.

The impact of adding platelet-rich plasma during fat graft myringoplasty for managing medium-sized tympanic membrane perforations: A prospective randomized case-control study.

PURPOSE: This study aimed to evaluate the effect of adding platelet-rich plasma (PRP) during FGM to close medium-sized TM perforations. METHODS: This prospective randomized case-control study was conducted from February 2017 to March 2022. We included 320 patients with a medium-sized TM perforation with inactive mucosal otitis media. Transcanal FGM managed all patients under general or local anesthesia according to the patient preference. According to PRP, patients were divided into two groups: the first with PRP (170 patients) and the other without PRP (150 patients). We evaluated the closure rate of both groups one month, six months, and one year after the surgery. Also, we assessed the audiological performance before and one year after the operation for the patients with a successful closure. RESULTS: The closure rate was 87.6 % in the first group and 72.7 % in the second group, with a statistically significant difference between both groups as the P-value, was 0.001. Successful closure of the ABG to <10 dB occurred in 95.3 % of group A and 90.8 % of group B without a statistically significant difference between both groups (P-value = 0.163). CONCLUSIONS: This prospective comparative study on a relatively large number of patients revealed that FGM effectively closed medium-sized TM perforations. It also significantly improved postoperative audiological performance in both groups. Adding PRP during the FGM enhanced the closure success and the healing process without recorded complications. We recommend using the PRP in the routine FGM for closing medium-sized TM perforations.