Angel Arnaout1, Jing Zhang1, Simon Frank1, Moein Momtazi1, Erin Cordeiro1,2, Amanda Roberts1, Ammara Ghumman1, Dean Fergusson2,3, Carol Stober2, Gregory Pond4, Ahwon Jeong2, Lisa Vandermeer2, Brian Hutton2,3, Mark Clemons2,3,5. 1. Department of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada. 2. Ottawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada. 3. Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, ON K1H 8L6, Canada. 4. Juravinski Cancer Center, McMaster University, Hamilton, ON L8S 4L8, Canada. 5. Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
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.
RCT Entities:
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.
Entities:
Keywords:
acellular dermal matrix; immediate breast reconstruction; mastectomy
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