From Brigham and Women's Hospital; Massachusetts General Hospital; Northwestern University Feinberg School of Medicine; Texas Health Harris Methodist Hospital Southlake; Texas Health Harris Methodist Hospital Fort Worth; Baylor Scott & White All Saints Medical Center; NorthShore University Health System; New York University School of Medicine; and Louisiana State University Health Science Center-New Orleans.
Plast Reconstr Surg. 2021 Sep 1;148(3):493-500. doi: 10.1097/PRS.0000000000008194.
Implant-based breast reconstruction accounts for the vast majority of breast reconstruction procedures and is commonly performed with human acellular dermal matrix. There is no consensus as to the optimal human acellular dermal matrix preparation, and high-quality evidence concerning comparative effectiveness is lacking. This study is the first prospective, multicenter, randomized controlled clinical trial to compare human acellular dermal matrix-related complications of the two most commonly used human acellular dermal matrices in implant-based breast reconstruction. The authors hypothesize that there will be no difference in infection, seroma, and reconstructive failure between FlexHD Pliable and AlloDerm RTU.
The authors conducted a Level 1 prospective, randomized, controlled, multicenter clinical trial to assess complications associated with the use of two human acellular dermal matrices in immediate postmastectomy implant-based breast reconstruction across seven clinical sites. Group A patients received FlexHD Pliable (113 patients with 187 breast reconstructions), and group B patients received AlloDerm RTU (117 patients with 197 breast reconstructions).
There was no significant difference with respect to patient demographics, indications, comorbidities, and reconstruction approach between groups. Mean follow-up time was 10.7 ± 3.2 months. There was no statistical difference in the overall matrix-related complications between groups A and B (4.3 percent versus 7.1 percent, p = 0.233). Obesity (OR, 1.14; 95 percent CI, 1.05 to 1.24; p = 0.001) and prepectoral placement of matrix (OR, 4.53; 95 percent CI, 1.82 to 11.3; p = 0.001) were independently associated with greater risks of overall matrix-related complications.
This work supports the use of human acellular dermal matrices in implant-based breast reconstruction and demonstrates no significant difference in matrix-related complication rates between FlexHD Pliable and AlloDerm RTU.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
基于植入物的乳房重建术占乳房重建手术的绝大多数，通常使用人去细胞真皮基质进行。目前尚无关于最佳人去细胞真皮基质准备的共识，也缺乏关于比较有效性的高质量证据。这项研究是第一项前瞻性、多中心、随机对照临床试验，旨在比较两种最常用于基于植入物的乳房重建的人去细胞真皮基质的相关并发症。作者假设，在 FlexHD Pliable 和 AlloDerm RTU 之间，植入物相关的感染、血清肿和重建失败的发生率没有差异。
作者进行了一项 1 级前瞻性、随机、对照、多中心临床试验，以评估两种人去细胞真皮基质在 7 个临床中心的即刻乳房切除术后基于植入物的乳房重建中使用的相关并发症。A 组患者接受 FlexHD Pliable（113 例患者 187 次乳房重建），B 组患者接受 AlloDerm RTU（117 例患者 197 次乳房重建）。
两组患者的人口统计学、适应证、合并症和重建方法均无显著差异。平均随访时间为 10.7±3.2 个月。A 组和 B 组之间的总体基质相关并发症无统计学差异（4.3%比 7.1%，p=0.233）。肥胖（OR，1.14；95%CI，1.05 至 1.24；p=0.001）和基质的胸肌前置（OR，4.53；95%CI，1.82 至 11.3；p=0.001）与总体基质相关并发症的风险增加独立相关。
本研究支持在基于植入物的乳房重建中使用人去细胞真皮基质，并表明 FlexHD Pliable 和 AlloDerm RTU 之间在基质相关并发症发生率方面无显著差异。
临床问题/证据水平：治疗性，I 级。
