Plastic Surgery Research Council
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PSRC 60th Annual Meeting
Program and Abstracts

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A Meta-Analysis Assessing Post-Surgical Outcomes between Aseptic and Sterile AlloDerm Regenerative Tissue Matrix
David Macarios, MBA1, Leah Griffin, MS2, Abhishek Chatterjee, MD, MBA3, Lauren J. Lee, PharmD, MS1, Cheryl Milburn, MS, MLIS1, Maurice Y. Nahabedian, MD4.
1LifeCell an Acelity company, Bridgewater, NJ, USA, 2Acelity, San Antonio, TX, USA, 3University of Pennsylvania Hospital, Philadelphia, PA, USA, 4Georgetown University Department of Plastic Surgery, Washington, DC, USA.

PURPOSE: AlloDerm, a human acellular dermal matrix is available in a Ready-to-Use (RTU) or Freeze-dried (FD) form. The RTU and FD are identical in their preparation except in the final steps, which result in the RTU provided in a terminally sterilized and hydrated form, while the FD is provided in a cryo-preserved dry form. To date, a limited number of studies have compared complication rates between RTU versus FD in women undergoing implant-based breast reconstruction (BR) with mixed results. The objective of this report was to conduct a meta-analysis of complication rates in previously reported studies that compared RTU and FD.
METHODS: A systematic review of the published literature was conducted using PubMed, limited to English, from 2010 to 2014, and supplemented by hand searches of journal reference lists. It was required that studies compared both RTU and FD. Data was abstracted by a single individual and then all abstracted data was cross checked by two independent reviewers. Odds ratios (OR) and relative risks (RR) including 95% confidence intervals (CI), taking into account study heterogeneity using Cochran’s Q-statistic, were calculated for each complication. Studies reporting patient-level results as opposed to breast-level results were excluded from the primary analysis, but included in subsequent sensitivity analysis. Variable follow-up time within and between studies was also considered in a sensitivity analysis.
RESULTS: PubMed and hand searches identified 275 eligible studies. Of these, 115 were eligible for detailed review. Only 5 studies compared outcomes of RTU to FD and of these 2 (Weichman et al. 2013 and Yuen et al. 2014) had breast-level data and one study (Buseman et al. 2013) had patient-level data appropriate for meta-analysis. The two studies included in the primary meta-analysis were conducted in the US (pooled sample size: N=116 RTU and N=109 FD or 205 and 186 breasts, respectively). Age and body mass index (BMI) were similar between the RTU and FD patients. Mean age for the RTU patients was 50.5±10.4 years compared to 49.8 ±11.2 years in the FD patients. BMI for the RTU patients was 27.3±7.6kg/m2 and 28.3±5.9 kg/m2 for the FD patients. Across all meta-analyses, there were no difference in complication rates between RTU versus FD : Cellulitis (RR=0.863 [95% CI=0.272-2.740]), seroma (RR=0.553 [95% CI=0.026-11.830]) and explantation (RR=0.593 [95% CI=0.247-1.425]). The seroma results were similar after including the Buseman et al. 2013 study: RR=1.578 (95% CI=0.302-8.255). Results remained non-significant even after adjustment for variable follow-up time.
CONCLUSIONS: The results from this meta-analysis suggest that there are no differences in complication rates between AlloDerm RTU or FD forms.


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