A Meta-analysis Assessing Postsurgical Outcomes between Aseptic and Sterile AlloDerm Regenerative Tissue Matrix

Abstract

Background: AlloDerm, a human acellular dermal matrix, is available in a ready-to-use (RTU) or freeze-dried (FD) form. A limited number of studies have compared complication rates between RTU and FD in implant-based breast reconstruction. The objective of this report was to conduct a meta-analysis of previously reported complication rates between RTU and FD.

Methods: A systematic literature review was conducted from 2010 to 2014 and supplemented by hand searches. Included studies compared both RTU and FD. Odds ratios and relative risks (RRs) with 95% confidence interval (CI), taking into account study heterogeneity, were calculated. Studies reporting patient-level results as opposed to breast-level results were excluded from the primary analysis but included in subsequent sensitivity analyses. Variable follow-up time within and between studies was also considered in a sensitivity analysis.

Results: Of the 275 identified studies, 115 studies were eligible for detailed review. Only 5 studies compared RTU with FD, and of these, 2 studies had breast-level data and 1 study had patient-level data appropriate for meta-analysis. The 2 studies included in the primary meta-analysis had a pooled sample size: n = 116 RTU and n = 109 FD patients, or 205 and 186 breasts, respectively. Age and body mass index were similar between groups. Across all meta-analyses, there were no differences in complication rates between RTU and 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). Results remained nonsignificant even after adjustment for variable follow-up time.

Conclusion: The results suggest that there are no differences in complication rates between RTU and FD forms.

Fig. 1.

Prisma flow diagram. A total of 275 records were identified through literature searches. The majority of articles (n = 160) did not identify the sterile product explicitly. Of the remaining, 103 did not have comparative data or were duplicates, leaving 5 studies for qualitative synthesis and 3 for meta-analysis.

Fig. 2.

OR for baseline analysis and sensitivity analysis. The overall OR for each complication shows no difference between sterile vs aseptic AlloDerm. The inclusion of patient-level data and time adjustment did not alter the conclusion under a variety of assumptions. OR or RR less than 1 favors sterile AlloDerm over aseptic AlloDerm. Buseman et al (a) assumed that all patients had unilateral reconstruction and reported complications are at the breast level. Buseman et al (b) assumed that all patients had bilateral reconstruction and the reported complication occurred in both breasts. Buseman et al (c) assumed that all patients had bilateral reconstruction and the reported complication occurred in only one breast.

Fig. 3.

Relative risk for baseline and sensitivity analyses. The overall RR for each complication shows no difference between sterile vs aseptic AlloDerm. The inclusion of patient-level data and time adjustment did not alter the conclusion under a variety of assumptions. OR or RR less than 1 favors sterile AlloDerm over aseptic AlloDerm. Buseman et al (a) assumed that all patients had unilateral reconstruction and reported complications are at the breast level. Buseman et al (b) assumed that all patients had bilateral reconstruction and the reported complication occurred in both breasts. Buseman et al (c) assumed that all patients had bilateral reconstruction and the reported complication occurred in only one breast.