Comparison of moist and dry environment in traumatic tympanic membrane perforation healing: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Traumatic tympanic membrane perforation (TTMP) is common worldwide, with a reported incidence as high as 6.1%. Conventional management advocates keeping the ear canal dry and strictly avoiding topical ear drops. Under this "dry-ear" regimen, however, tympanic membrane (TM) healing is often slow and often ineffective, especially for large perforations. We previously demonstrated that both exogenous growth factors and 0.3% (w/v) ofloxacin eardrops can accelerate closure of TTMP, with no significant difference in efficacy between the two treatments. This raised the question of whether the moist environment itself-rather than the mitogenic effect of the growth factor-might be the principal driver of repair. To test this hypothesis, we sought to evaluate the effect of moisture by creating a purely humid milieu. Normal saline is the standard vehicle used to maintain a moist wound bed in cutaneous healing, yet to date no clinical study has evaluated its efficacy in TTMP repair.

OBJECTIVE: This study intends to verify whether the moist environment alone can result in a better TTMP healing than a dry environment and to confirm the additional effect of ofloxacin and growth factor.

METHODS: The study will compare the TTMP healing across dry versus moist environments created by saline, 0.3% (w/v) ofloxacin, or basic fibroblast growth factor (bFGF). The first phase will enroll 130 patients randomized evenly into the moisture group and the control group, with 65 each. If the moisture group demonstrates significantly shorter healing times and a superior sealing rate, the second phase will be launched as a triple-blind randomized controlled trial (RCT) with 150 patients who will be assigned into one of the three groups ((i) saline, (ii) ofloxacin, and (iii) bFGF). Otoscopy will be performed pre-treatment and weekly post-treatment to assess perforation size and signs of middle-ear infection (e.g., secondary purulent otorrhea) until closure or up to 3 months, whichever comes first. A comprehensive hearing test, including pure-tone audiometry, tympanometry, and distortion product otoacoustic emissions (DPOAE), will be conducted before and after perforation closure.

ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital (approval number 2023-006-(1)). The results from this study will be published in peer-reviewed journals and presented at relevant conferences.

TRIAL REGISTRATION: ChiCTR ChiCTR2400084582, Registered on 21 May 2024. https://www.chictr.org.cn/bin/project/edit?pid=224331 .