Surgical outcomes of tympanoplasty using a sterile acellular dermal allograft: a prospective randomised controlled study

Lee, J. M.; Seo, Young‐Joon; Shim, Dae Bo; Lee, H. J.; Kim, Sung Huhn

doi:10.14639/0392-100x-1839

Cited by 17 publications

(29 citation statements)

References 21 publications

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“…Two studies did not use autologous grafts as a control group [ 19 , 21 ], and one study did not focus on TM perforation [ 20 ]. Five retrospective cohort studies and four randomized controlled studies with a total of 610 participants were included in the present meta-analysis [ 8 , 22 – 29 ]. For further details, see Fig.…”

Section: Resultsmentioning

confidence: 99%

“…All of the included studies used human-derived ADM for TM grafting. Four studies used the temporalis fascia as the control group [ 8 , 23 , 24 , 29 ], three used the tragal perichondrium [ 22 , 26 , 28 ], and two combined multiple autologous grafts as the control group [ 25 , 27 ]. Three studies only included patients with suppurative otitis media [ 24 , 25 , 29 ], and one study included patients with middle ear cholesteatoma [ 23 ].…”

Section: Resultsmentioning

confidence: 99%

“… Vos 2005 [ 27 ] Retrospective cohort study Patients underwent type I tympanoplasty without mastoidectomy or ossicular chain reconstruction ADM (human-derived), n = 25 Autologous temporalis fascia, n = 56; Autologous fascia plus cartilage reconstruction, n = 33 Not report Graft success rate; Audiometric tests(ABG); Complications ADM is an effective TM graft when used in type I tympanoplasty Yang 2019 [ 28 ] Retrospective cohort study Patients of tympanic membrane perforations who underwent tympanoplasty ADM (human-derived), n = 27 Autologous tragal perichondrium, n = 34 6 months Graft success rate; Operation time; Audiometric tests(ABG) ADM can be recommended as an attractive alternative to cartilage grafts Fu 2017 [ 29 ] Retrospective cohort study Chronic suppurative otitis media patients underwent type I tympanoplasty ADM (human-derived), n = 32 Autologous temporalis fascia, n = 28 3 months Graft success rate; Operation time; Postoperative pain Audiometric tests(ABG) The effect of ADM for repairing tympanic membrane is similar to the temporalis fascia. Lee 2018 [ 22 ] Prospective randomised controlled study Patients who underwent type I tympanoplasty for tympanic membrane perforation ADM (human-derived), n = 27 Autologous tragal perichondrium, n = 33 6 months Graft success rate; Operation time; Postoperative pain; Audiometric tests(ABG,AC,BC); Complications ADM was shown to be an effective alternative to tragal perichondrium. Li 2014 [ 23 ] Randomised controlled study Middle ear cholesteatoma patients underwent tympanoplasty for tympanic membrane perforation ADM (human-derived), n = 30 Autologous temporalis fascia, n = 22 12 months Graft success rate; Audiometric tests(ABG) ADM was shown to be an effective alternative to the temporalis fascia Raj 2011 [ 24 ] Prospective ra...…”

Section: Resultsmentioning

confidence: 99%

“…None of the included randomized controlled studies adequately provided methodological information. Only one study reported the method that was used to generate the random sequence [ 22 ]. One study was assessed as having a high risk of performance bias because it was an unblinded controlled trial [ 24 ].…”

Section: Resultsmentioning

confidence: 99%

“…The use of ADM to repair TM perforations is promising because it is readily available and relatively easy to apply [ 19 – 21 ]. Acellular dermal matrix was shown to be an effective alternative to autologous grafts in some randomized controlled trials [ 22 – 25 ]. Retrospective studies also confirmed these success rates, and hearing improvements were similar for ADM and autologous grafts for tympanoplasty [ 8 , 26 – 29 ].…”

Section: Introductionmentioning

confidence: 99%

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Human-derived acellular dermal matrix may be an alternative to autologous grafts in tympanic membrane reconstruction: Systematic review and meta-analysis

Sun

Yang

et al. 2021

Journal of Otolaryngology - Head & Neck Surgery

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Background Human-derived acellular dermal matrix (ADM) has been widely used as an effective alternative to autologous grafts in tympanoplasty. However, evidence of ADM as an alternative to autologous grafts in the repair of tympanic membrane (TM) perforation still lacks adequate empirical evidence. Objectives To determine the clinical safety and efficacy of human-derived ADM as TM graft material for tympanoplasty. Data sources The PubMed, EMBASE, Cochrane Library, EBSCO, Ovid, Scopus, and Web of Science databases and reference lists of the retrieved articles were searched, with no language restriction. Selection criteria All randomized controlled trials and retrospective cohort studies that compared the use of human-derived ADM and autologous grafts in tympanoplasty for TM perforation were included. Data collection and analysis Two review authors independently assessed risk of bias in the included studies and extracted data. The pooled results for continuous data were reported as a mean difference (MD) and 95% confidence intervals (CI). For dichotomous data, odds risk (OR) with 95% CI was used. ChI2 statistic and Galbraith plots were used to assess the heterogeneity. Publication bias was assessed with a funnel plot and Egger’s test. Main results Five retrospective cohort studies and four randomized controlled studies with a total of 610 participants were included in the meta-analysis. No significant differences in graft success (OR: 0.71 [0.39, 1.29], p = 0.26), air-bone gap (ABG) reduction (MD: − 0.59 [− 3.81, 1.19], p = 0.51), or complications (OR: 1.23 [0.07, 20.64], p = 0.89) were found between the ADM group and autologous graft group. The use of ADM significantly shortened tympanoplasty surgery time (MD: − 16.14 [− 21.22, − 11.07], p < 0.00001) and reduced postoperative pain (MD: − 2.57 [− 3.57, − 1.58], p < 0.00001) compared with the autologous graft group. Conclusion Human-derived ADM might be an effective alternative to autologous grafts for tympanoplasty. However, some of the studies that were included in the present meta-analysis had rather low methodological quality, and more adequately designed clinical trials should be performed in the future. Graphical abstract

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