Objective: To investigate whether the contralateral normal external auditory canal (EAC) skin graft can maintain the ear canal health after EAC reconstruction in unilateral congenital aural atresia (CAA) cases. Methods: A Zelen design randomized controlled study was used to collect unilateral CAA patients for EAC reconstruction prospectively (clinical trial registration number: ChiCTR2000032103). The patients were randomly divided into the control group and the trial group. The trial group used the contralateral normal EAC skin graft group (transplant part of the contralateral normal EAC skin to repair the atresia side for unilateral CAA patients), the control group all used scalp blade thick skin. We observed the EAC health and hearing results of the two groups after EAC reconstruction. Results: A total of 13 cases were enrolled from July 2020 to August 2021. There were eight patients in the trial group, including six males and two females, with an average age of 22.3 years (14-36 years). There were two patients with CAA on the left and six patients on the right. The average follow-up time was 8.8 months (4-14 months). There were five patients in the control group, all cases were male with an average age of 16.2 years (12-20 years). There were four patients with CAA on the left and one patient on the right. The average follow-up time was 7.0 months (2-14 months). In the trial group, eight cases of reconstructed EAC epithelium were healthy, one patient had cicatricial stenosis of EAC opening and lateralization of the tympanic membrane. The other patient had cicatricial stenosis of reconstructed EAC, this case also had scar hyperplasia of the contralateral EAC opening but recovered after soft packing and triamcinolone acetonide injection treatment. The healthy side EAC of the rest trial group had no scarring stenosis or local bone hyperplasia during long-term follow-up. In the control group, one patient was lost to follow-up and the other four patients had dry ears of reconstructed EAC, but easily to form crusts and needed to be cleaned repeatedly, one patient had lateralization of the tympanic membrane, the EAC epithelium was not healthy for long-term follow-up. The incidence of complications related to EAC reconstruction was lower than previous studies (χ²=5.55, P=0.018), and the average postoperative Air-Bone Gap increased (18.8±10.0)dB. Conclusion: By optimizing the EAC reconstruction technology, the health of the reconstructed EAC is improved compared with the previous study. After active intervention and treatment, there should be no scarring stenosis or local bone hyperplasia on the contralateral side EAC.
目的： 探讨健侧外耳道皮片移植在先天性外耳道闭锁患者耳道再造术后外耳道健康维持中的作用。 方法： 收集年龄≥12岁、Jahrsdoerfer评分≥8分的单侧先天性外耳道闭锁患者，开展外耳道再造术（临床试验注册号ChiCTR2000032103）。采用双组同意Zelen设计，按照入选的先后顺序，根据计算机预先生成的随机对照表将患者分为试验组和对照组。对照组外耳道植皮全部采用头皮刃厚皮片；试验组患侧外耳道植皮软骨段区域增加一条取自健侧外耳道软骨段后壁5 mm宽的全厚条形皮片，再造外耳道余下区域及健侧外耳道皮肤缺损部分均采用头皮刃厚皮片植皮。观察两组患者术后再造外耳道的健康维持状况及听力改善情况。 结果： 2020年7月至2021年8月共入组13例单侧先天性外耳道闭锁患者。试验组8例，其中男性6例、女性2例，平均年龄22.3岁（14~36岁），左侧外耳道闭锁2例、右侧6例，平均随访时间8.8个月（4~14个月）；对照组5例，均为男性，平均年龄16.2岁（12~20岁），左侧外耳道闭锁4例，右侧1例，平均随访时间7.0个月（2~14个月）。试验组中8例再造外耳道上皮健康，1例出现再造外耳道口瘢痕性狭窄及鼓膜外侧移位，另1例出现再造外耳道口瘢痕性狭窄伴健侧外耳道口瘢痕增生，予以软性填塞及曲安奈德注射治疗后恢复，其余患者健侧外耳道取皮处随访无瘢痕性狭窄或局部骨质增生等情况。对照组中1例患者未按时随访导致失访，余下4例再造外耳道干耳，但易形成痂皮，需反复清理，1例出现鼓膜外侧移位，长期随访外耳道上皮欠健康，其外耳道后壁上皮菲薄，清理时易出血。随访的12例患者再造外耳道相关并发症发生率较前期研究降低（χ²=5.55，P=0.018），术后平均气骨导差缩小（18.8±10.0）dB。 结论： 通过健侧外耳道皮片移植及术后积极干预处理，先天性外耳道闭锁再造耳道的健康情况较前期改善，健侧外耳道取皮处无瘢痕性狭窄或局部骨质增生等情况。.