Recombinant human lubricin for prevention of postoperative intra-abdominal adhesions in a rat model.

Background: Postoperative intra-abdominal adhesions are a major cause of morbidity and mortality and contribute to a heavy burden on health care resources. At present, numerous introduced adhesion prevention products have demonstrated some benefit but none are consistently effective. The aim of this study was to examine the effectiveness of recombinant human lubricin in preventing intra-abdominal adhesion formation.

Materials And Methods: A total of 62 male Wistar Albino rats were randomly assigned to the study. Six rats were used to the initial pilot study and 56 rats were randomized into four groups: (1) control cecal abrasion; (2) treatment cecal abrasion with 0.5 mg/mL lubricin solution; (3) control cecal enterotomy and primary closure; and (4) treatment cecal enterotomy and primary closure with 0.5 mg/mL lubricin solution. Rats were sacrificed at 3 d and 21 d postoperatively for the pilot and main studies, respectively. Macroscopic and microscopic adhesion severity was graded by blinded investigators.

Results: For the pilot study, all six rats successfully reached the end point indicating safety of the lubricin gel. In the main randomized study, adhesions in the treated cecal abrasion group were significantly reduced both macroscopically (P = 0.001) and microscopically (fibrosis P = 0.009, inflammation P < 0.0001), when compared with the control group. In the cecal enterotomy group, adhesions were reduced for the treatment group in macroscopic (P = 0.011) and microscopic grading (fibrosis P = 0.500, inflammation P = 0.206) compared with the control group.

Conclusions: Recombinant human lubricin significantly reduced both macroscopic and microscopic intra-abdominal adhesions in the cecal abrasion group. The cecal enterotomy group showed modest macroscopic adhesion reduction. Future study using higher concentration of lubricin solution are needed to investigate its toxicity and more profound antiadhesion properties in significant operations.