A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction

Abstract

Background: The effectiveness of different acellular dermal matrices (ADM) used for implant-based reconstruction immediately following mastectomy is an important clinical question. A prospective randomized clinical trial was performed to evaluate the superiority of DermACELL over Alloderm-RTU in reducing drain duration. Methods: Patients undergoing mastectomy with subpectoral immediate and permanent implant-based breast reconstruction were randomized to Alloderm-RTU or DermACELL. The primary outcome was seroma formation, measured by the duration of postoperative drain placement. Secondary outcomes included: post drain removal seroma aspiration, infection, redbreast syndrome, wound dehiscence, loss of the implant, and unplanned return to the operating room. Results: 62 patients were randomized for 81 mastectomies (41 Alloderm-RTU, 40 DermACELL). Baseline characteristics were similar. There was no statistically significant difference in mean drain duration (p = 0.16), with a trend towards longer duration in the Alloderm-RTU group (1.6 days; 95%CI, 0.7 to 3.9). The overall rate of minor and major complications were statistically similar between the two groups; although patients with Alloderm-RTU had 3 times as many infections requiring antibiotics (7.9% vs. 2.5%) with a risk difference of 5.4 (95%CI −4.5 to 15.2), and twice as many unplanned returns to the operating room (15.8% vs. 7.5%) with a risk difference of 8.3 (95% CI −5.9 to 22.5) as DermACELL. Conclusion: This is the first prospective randomized clinical trial comparing the two most commonly used human-derived ADMs. There was no statistically significant difference in drain duration, minor, or major complications between DermACELL over Alloderm-RTU in immediate subpectoral permanent implant-based breast reconstruction post-mastectomy.

Direct comparison of CGCRYODERM and DermACELL in the same patient for outcomes in bilateral implant-based breast reconstruction: a retrospective case series

“…Previous studies have shown relatively lower complication rates of sterile pre-hydrated ADMs compared with other aseptic or/and freeze-dried ones (17,23,24). Conversely, there is increasing evidence that no statistically significant differences were observed between sterile versus aseptic ADMs in drain duration and complications after IBR (16,18,25,26). In this study, the results indicate that CGCRYODERM has a safety profile comparable with that of DermACELL.…”

Comparison of Skin Substitutes for Acute and Chronic Wound Management

“…13 AlloDerm (Allergan Inc., Madison, NJ), DermACELL (LifeNet Health, Virginia Beach, VA), and Graftjacket (Wright Medical Group N.V., Memphis, TN) are three popular human-derived ADMs that provide nonliving dermal scaffolding of collagen, elastin, and glycosaminoglycans to open wound beds to promote healing. 14 The long shelf lives and increased supply compared with skin grafting have made these acellular dermal allografts a popular choice for wound coverage. Further, they provide a barrier against infection, help decrease fluid losses, and provide a more favorable wound bed for future skin grafting.…”

“…17 AlloDerm requires 10 to 14 minutes of rehydration prior to application; however, the Ready-To-Use product only requires 2 minutes of rehydration. 14 AlloDerm grafts have been shown to be tolerant to infection and revascularize quickly. 14 DermACELL, in comparison, can also be stored at room temperature, but it is ready to use directly out of the package.…”

“…14 AlloDerm grafts have been shown to be tolerant to infection and revascularize quickly. 14 DermACELL, in comparison, can also be stored at room temperature, but it is ready to use directly out of the package. 13 A randomized controlled trial comparing DermACELL use for venous leg ulcers (VLU) with conventional wound care management demonstrated significant reduction in wound size (59.6 vs. 8.1%) at 24 weeks from one application of DermACELL (p < 0.01).…”

“…22 These same human-derived ADMs have gained considerable use in expander-based breast reconstruction and abdominal wall reconstruction. 13,14,23,24 They are indicated for reinforcing soft-tissue repairs and facilitating wound healing, especially in hostile environments such as irradiated or infected tissue. 25 A recent randomized controlled trial comparing AlloDerm Ready-To-Use with DermACELL in immediate subpectoral implant-based breast reconstruction demonstrated no statistically significant differences in complication incidences, although AlloDerm Ready-To-Use was 35% more expensive at the research site.…”