Betadine Soaking of Silicone Coupons Minimally Impacts Acellular Dermal Matrix Incorporation in a Preclinical Primate Model

BACKGROUND: Microbial pathogens local to prosthetic breast devices may promote infection, inflammation, and capsular contracture. Although antimicrobial solutions have been used, their effects on human acellular dermal matrix (HADM) incorporation when used with prosthetic devices are unknown. The authors’ objective was to histologically assess the effect of 10% povidone iodine (PI)–saturated tissue expander (TE) exposure on HADM biological response in a primate model. They hypothesized that PI exposure would not negatively affect the HADM biological response. METHODS: Samples (1.5 × 1.5 cm) from smooth silicone TEs were saturated in saline or PI for 2 minutes and sutured to HADM to create HADM/TE constructs. Primates implanted subcutaneously with saline (n = 9) and PI-treated HADM/TE (n = 9) construct pairs were evaluated histologically for biological response after 2 or 4 weeks by means of a host response scoring scale (1 to 9), including recellularization, neovascularization, and inflammation. Inflammatory cells (eosinophils, lymphocytes, neutrophils, histiocytes, foreign-body giant cells) and evidence of HADM remodeling (fibroblasts, vessels) were further evaluated by means of a cell-specific scoring scale (0 to 4) and corroborated by immunostaining (CD3, CD20, CD68, FSP-1, collagen type IV). RESULTS: Mean histology scores were similar between saline- and PI-exposed HADM at 2 weeks (5.3 ± 0.9 and 5.6 ± 0.5; P = 0.52) and 4 weeks (4.6 ± 1.0 and 4.2 ± 0.9; P = 0.44). There was no difference in inflammatory cell presence at 2 and 4 weeks between groups. Fibroblast infiltration differences were insignificant between groups but exhibited trends toward an increase between time points for saline (1.6 ± 0.7 to 1.8 ± 0.8) and PI (1.3 ± 0.8 to 1.8 ± 1.0) groups, suggesting HADM incorporation over time. CONCLUSION: Data suggest that HADM exposure to PI-treated TEs does not negatively affect inflammation, vascularization, recellularization, incorporation, or host response to HADM in this model. CLINICAL RELEVANCE STATEMENT: PI is a surgical pocket irrigant used to address bacterial colonization, but its impact on ADM incorporation is unknown. This study demonstrates similar biologic response to ADMs adjacent to PI- or saline-saturated TEs in a primate model.