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 widespread implementation of acellular dermal matrix (ADM) has broadened the reconstructive repertoire for alloplastic breast reconstruction. ADM’s role in the context of postoperative radiation therapy remains unclear. The present review will evaluate whether ADM reduces complication rates in patients undergoing post-mastectomy radiation therapy (PMRT).
Methods
A healthcare librarian assisted in performing a search strategy of electronic databases MEDLINE (via Ovid), EMBASE, and CENTRAL. A combination of the keywords and Medical Subject Headings (MESH) to describe the various commercially available ADMs and terms for radiation therapy will be used. The search strategy will identify patients undergoing postoperative radiation following implant-based breast reconstruction and compare outcomes between those with and without ADM. Extracted data will include patient demographics, intraoperative data, and postoperative complications. Data on patient satisfaction and resource utilization will also be extracted if available. The references of selected works will be reviewed for additional studies meeting study criteria. Only peer-reviewed papers written in English will be included. The study data will be assessed for risk of bias and heterogeneity. Providing that sufficient studies can be identified, a meta-analysis will be performed. This review has been registered with PROSPERO (CRD42017056495).
Conclusions
To date, the short- and long-term performance of ADM in the context of postoperative radiation remains unclear. The objective of the present review will be to critically evaluate the literature with the intention of improving postoperative outcomes in the context of mastectomy and radiation.
Electronic supplementary material
The online version of this article (10.1186/s13643-019-0958-z) contains supplementary material, which is available to authorized users.
Highlights
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The gram-negative rod is a causal organism of endocarditis and osteomyelitis.
Early identification can inform treatment and prevent severe complications.
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