Wang Nigel, Isaacson Glenn
From the Departments of Otolaryngology, Head & Neck Surgery and Pediatrics, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
From the Departments of Otolaryngology, Head & Neck Surgery and Pediatrics, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Int J Pediatr Otorhinolaryngol. 2020 Aug;135:110136. doi: 10.1016/j.ijporl.2020.110136. Epub 2020 May 26.
Gelfilm® is no longer available for use in myringoplasty. We have substituted a commercially available collagen matrix (Biodesign® Otologic Repair Graft) for Gelfilm® as on onlay patch after removal of retained tympanostomy tubes. We compare the effectiveness of these two materials for post-tympanostomy tube myringoplasty.
Surgeries were performed in the same manner by residents supervised by the same surgeon during consecutive time periods. Tympanostomy tubes were removed under general anesthesia using a pick and cup forceps. Margins of the resultant perforation were rimmed and a patch placed on the lateral surface of the drum to cover the perforation. Children were seen at 4 weeks after surgery. Tympanic membrane closure was assessed by otoscopy and tympanometry. Patient age at time of myringoplasty, laterality (right/left/bilateral), and presence or absence of a persistent perforation at one month follow-up were tabulated. Total duration of tympanic intubation, tube design and material, reason for tube removal, and additional risk factors (trisomy 21, cleft palate, midfacial anomalies) were analyzed.
55 children met inclusion criteria. 28 children (36 ears) were patched with Gelfilm®. 27 children (35 ears) were patched with collagen matrix. Median ages at surgery and duration of intubation were similar in the two groups. There were persistent perforations at 4 weeks in 5/28 children (5/36 ears, 14%) with Gelfilm®, and 3/27 children (3/35 ears, 9%) with collagen matrix. There was no significant difference in the rate of persistent perforation between the two materials by Fisher's exact test by patients (p = 0.7049) or by ears (p = 0.7101; OR: 1.72; 95% CI 0.38-7.82).
Gelfilm® and collagen matrix patches performed similarly in the operating room. Rates of tympanic membrane closure were comparable in this pilot study. Larger patient numbers will be needed to prove equivalence or superiority of collagen matrix for this application.
明胶海绵（Gelfilm®）不再用于鼓膜成形术。在取出保留的鼓膜造口管后，我们用一种市售的胶原基质（生物设计®耳科修复移植物）替代明胶海绵作为覆盖贴片。我们比较这两种材料用于鼓膜造口管取出术后鼓膜成形术的有效性。
在连续时间段内，由同一位外科医生监督住院医师以相同方式进行手术。在全身麻醉下使用耳科剥离钳和杯状钳取出鼓膜造口管。对 resulting 穿孔的边缘进行修整，并在鼓膜外表面放置一块贴片以覆盖穿孔。术后4周对患儿进行检查。通过耳镜检查和鼓室导抗图评估鼓膜闭合情况。将鼓膜成形术时的患者年龄、患侧（右/左/双侧）以及术后1个月时是否存在持续性穿孔进行列表。分析鼓膜置管的总时长、导管设计和材料、拔管原因以及其他风险因素（21三体综合征、腭裂、面中部畸形）。
55名儿童符合纳入标准。28名儿童（36耳）用明胶海绵进行贴片。27名儿童（35耳）用胶原基质进行贴片。两组手术时的中位年龄和置管时长相似。使用明胶海绵的28名儿童中有5名（36耳中的5耳，14%）在4周时存在持续性穿孔，使用胶原基质的27名儿童中有3名（35耳中的3耳，9%）存在持续性穿孔。通过Fisher精确检验，两种材料之间患者的持续性穿孔率无显著差异（p = 0.7049），耳的持续性穿孔率也无显著差异（p = 0.7101；OR：1.72；95% CI 0.38 - 7.82）。
明胶海绵和胶原基质贴片在手术室中的表现相似。在这项初步研究中，鼓膜闭合率相当。需要更多患者数量来证明胶原基质在此应用中的等效性或优越性。
