Munich, Oberschleissheim, and Bochum, Germany; Linz, Austria; and Southampton, Hampshire, United Kingdom From the Department of Oral and Maxillofacial Surgery, Technische Universität München; Department of Oral and Maxillofacial Surgery, General Hospital of Linz; Clinic for Swine, Faculty of Veterinary Medicine, Ludwig-Maximilians-University of Munich; Department of Oral and Maxillofacial Surgery, Southampton University Hospital NHS Foundation Trust; and Department of Plastic Surgery, Burn Unit, BG University Hospital Bergmannsheil, Ruhr University Bochum.
Plast Reconstr Surg. 2013 Jul;132(1):172-181. doi: 10.1097/PRS.0b013e3182910b50.
Oronasal fistulas are a frequent complication after cleft palate surgery. Numerous repair methods have been described, but wound-healing problems occur often. The authors investigated, for the first time, the suitability of multilayered amniotic membrane allograft for fistula repair in a laboratory experiment (part A), a swine model (part B), and an initial patient series (part C).
In part A, one-, two-, and four-layer porcine and human amniotic membranes (n = 20 each) were fixed in a digital towing device and the force needed for rupture was determined. In part B, iatrogenic oronasal fistulas in 18 piglets were repaired with amniotic membrane allograft, autofetal amniotic membrane, or small intestinal submucosa (n = 6 each). Healing was evaluated by probing and visual inflammation control (no/moderate/strong) on postoperative days 3, 7, 10, and 76. Histological analysis was performed to visualize tissue architecture. In part C, four patients (two women and two men, ages 21 to 51 years) were treated with multilayered amniotic membrane allograft.
In part A, forces needed for amniotic membrane rupture increased with additional layers (p < 0.001). Human amniotic membrane was stronger than porcine membrane (p < 0.001). In part B, fistula closure succeeded in all animals treated with amniotic membrane with less inflammation than in the small intestinal submucosa group. One fistula remained persistent in the small intestinal submucosa group. In part C, all fistulas healed completely without inflammation.
Amniotic membrane is an easily available biomaterial and can be used successfully for oronasal fistula repair. The multilayer technique and protective plates should be utilized to prevent membrane ruptures.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.
腭裂手术后，口鼻瘘是一种常见的并发症。已经描述了许多修复方法，但经常出现伤口愈合问题。作者首次在实验室实验（A 部分）、猪模型（B 部分）和初步患者系列（C 部分）中研究了多层羊膜同种异体移植物修复瘘管的适用性。
在 A 部分，将单层、双层和四层猪和人羊膜（各 20 个）固定在数字牵引装置中，并确定破裂所需的力。在 B 部分，用羊膜同种异体移植物、自体胎儿羊膜或小肠黏膜下层（每组 6 个）修复 18 头小猪的医源性口鼻瘘。通过探查和视觉炎症控制（无/中度/强）在术后第 3、7、10 和 76 天评估愈合情况。进行组织学分析以观察组织结构。在 C 部分，用多层羊膜同种异体移植物治疗 4 名患者（2 名女性和 2 名男性，年龄 21 至 51 岁）。
在 A 部分，羊膜破裂所需的力随层的增加而增加（p < 0.001）。人羊膜比猪羊膜强（p < 0.001）。在 B 部分，所有用羊膜治疗的动物瘘管均闭合，炎症程度低于小肠黏膜下层组。小肠黏膜下层组中有一个瘘管持续存在。在 C 部分，所有瘘管均完全愈合，无炎症。
羊膜是一种容易获得的生物材料，可成功用于口鼻瘘修复。应利用多层技术和保护板防止膜破裂。
临床问题/证据水平：治疗，V。
