Acellular Dermal Matrix-Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues.

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.

Factors affecting composite graft survival in digital tip amputations.

Distal fingertip amputations present the hand surgeon with a myriad of treatment options. Composite tissue replantation offers the patient the possibility of maintaining digital length and function. The purpose of this study was to determine the efficacy of this treatment modality and to support its use. During a 2.5-year period, 53 patients with 57 digital tip amputations distal to the distal interphalangeal (DIP) joint underwent composite tissue grafting of the tip with minimal defatting. All patients were evaluated in a prospective manner. Specific information regarding the patient and the injury were recorded. The survival rates for amputations distal to the eponychium and between the DIP joint and eponychium were 58% and 43%, respectively. Smoking was the only significant factor that had a strong, independent association with graft loss. Age older than 18 years and alcohol use appeared only initially to have an effect on graft survival because they were so closely linked with smoking. Diabetes mellitus and crush-type injuries may potentially predispose a graft to fail, but a larger sample size is needed to prove this with significance. There were no infections or serious complications, even in those grafts that failed. After reviewing the data, the authors recommend using composite tissue replantation for fingertip amputations distal to the DIP joint in nonsmokers.