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.
Background: The objective of this study was to compare the economic impact of complete decongestive therapy and lymphovenous bypass in the management of upper extremity lymphedema. Methods: Economics were modeled for a patient with breast cancer–related lymphedema undergoing three different clinical pathways: (1) complete decongestive therapy alone; (2) lymphovenous bypass no longer requiring ongoing complete decongestive therapy; or (3) lymphovenous bypass requiring ongoing complete decongestive therapy. Activity-based cost analysis identified costs incurred with complete decongestive therapy and lymphovenous bypass. Costs were retrieved from supplier price lists, physician fee schedules, lymphedema therapists, and literature reviews. The net present value of all costs incurred for each clinical pathway were calculated. Results: The estimated net present value of all costs for a patient with breast cancer–related lymphedema undergoing treatment were as follows: (1) complete decongestive therapy alone ($30,400); (2) lymphovenous bypass no longer requiring ongoing complete decongestive therapy ($15,000); or (3) lymphovenous bypass requiring ongoing complete decongestive therapy ($42,100). The expected net present value of all costs for lymphovenous bypass was $26,800, which was comparable to that of complete decongestive therapy alone. Sensitivity analysis demonstrated that the expected net present value of lymphovenous bypass was dependent on the patient’s life expectancy, number of bypass anastomoses, and likelihood of discontinuing complete decongestive therapy. Conclusions: Lymphedema has substantial ongoing costs irrespective of the treatment modality. The cost of lymphovenous bypass appears comparable to that of complete decongestive therapy alone—the surgical costs of lymphovenous bypass are offset by the savings from discontinued ongoing therapy. Despite its limitations as a theoretical economic model, this study provides insight into the potential economic impact of lymphovenous bypass.
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