Microporous Polysaccharide Hemospheres for Adhesion Prevention: A Randomized Controlled Trial

Abstract

Abstract

Objective: This study was undertaken to determine the efficacy of Arista® (microporous polysaccharide hemospheres [MPH]) to reduce postoperative adhesion formation, compared to lactated Ringer's solution (LRS) and Seprafilm® (chemically modified hyaluronic acid/carboxymethylcellulose membranes [CMHA-CMCM], Genzyme Corp., Cambridge, MA). Design: This was a three-arm, randomized, investigator-blinded, animal-based trial. Materials and Methods: For this study, 300-g female Sprague-Dawley rats were randomized to receive MPH, CMHA-CMCM, or LRS. Barriers were placed following adhesion creation at the cecum and uterus in each animal and graded 30 days later grossly and histologically. Primary outcomes were differences in gross and histologic adhesions between MPH and LRS at the cecum and uterus of each rat. The study was powered at 80%. Results: The final analysis included 94 rats. Rats receiving MPH had no difference in gross adhesion score at either the cecum (odds ratio [OR]: 0.54; 95 confidence interval [CI]: 0.21–1.40; p=0.20) or the uterus (OR: 0.79; 95% CI: 0.32–1.98; p=0.62), compared to LRS. No difference in collagen formation was found at the cecum (OR: 1.22; 95% CI: 0.46–3.23; p=0.680) or uterus (OR: 3.61; 95% CI: 1.17–11.08; p=0.03). Likewise, no difference was found between inflammation at the cecum (OR: 1.69; 95% CI: 0.41–7.04; p=0.47) or uterus (OR: 1.23; 95% CI: 0.36–4.22; p=0.74). No difference in either gross or histologic adhesion scores was found between MPH and CMHA-CMCM. Conclusions: MPH did not reduce postoperative adhesion formation, compared to LRS or CMHA-CMCM at the cecum or uterus when examined grossly and histologically. (J GYNECOL SURG 29:196)