A Microbiological and Ultrastructural Comparison of Aseptic versus Sterile Acellular Dermal Matrix as a Reconstructive Material and a Scaffold for Stem Cell Ingrowth

Background: Recent data suggest an increased risk for infection when acellular dermal matrix is used in breast reconstruction. This may be because some acellular dermal matrices are actually not terminally sterilized but are instead “aseptically processed.” This study evaluates aseptic and sterile matrices for evidence of bacterial contamination and whether or not terminal sterilization affects matrix collagen architecture and stem cell ingrowth. Methods: Five separate samples of 14 different matrices were analyzed by fluorescent in situ hybridization using a bacterial DNA probe to detect bacterial DNA on the matrices. Separate samples were incubated for bacteria, acid-fast bacilli, and fungi for 2 to 6 weeks to detect living organisms. The impact of terminal sterilization on the collagen network and stem cell ingrowth on the matrices was then assessed. Results: Traces of bacterial DNA were encountered on all matrices, with more bacteria in the aseptic group compared with the sterile group (3.4 versus 1.6; p = 0.003). The number of positive cultures was the same between groups (3.8 percent). Electron microscopy demonstrated decreased collagen organization in the sterile group. Stem cell seeding on the matrices displayed a wide variation of cellular ingrowth between matrices, with no difference between aseptic and sterile groups (p = 0.2). Conclusions: Although there was more evidence of prior bacterial contamination on aseptically processed matrices compared with sterile matrices; clinical cultures did not differ between groups. Terminal sterilization does not appear to affect stem cell ingrowth but may come at the cost of damaging the collagen network. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, V.