Reduction of postoperative adhesions by N,O-carboxymethylchitosan: a pilot study.

OBJECTIVE

To examine the logistics, safety, and efficacy of N,O-carboxymethylchitosan (NOCC) in reducing adhesions in women.

DESIGN

Multicenter, prospective, randomized, reviewer-blinded clinical trial.

SETTING

Gynecologic practices.

PATIENT(S): Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis.

INTERVENTION(S): Adhesion reduction by administration of NOCC vs. Ringer's lactate at the conclusion of the initial surgical procedure, as assessed at second-look laparoscopy. The NOCC was applied as 200 mL of a 1% NOCC gel that was tamped in place, followed by 100 mL of 2% NOCC solution. Efficacy was assessed by covariate analysis.

MAIN OUTCOME MEASURE(S): Safety and postoperative adhesion formation.

RESULT(S): Groups did not differ in age, ethnicity distribution, height, weight, or body mass index. No deaths or serious adverse events were attributable to NOCC, and no adverse events were definitively or probably related to NOCC administration. Adhesions recurred at 61% of sites in controls and 38% of sites in NOCC recipients. De novo grade 1a and 1b adhesions tended to occur more commonly in controls than NOCC recipients. Adhesion extent and severity at second look were also less in NOCC recipients.

CONCLUSION(S): Intraperitoneal use of NOCC gel and solution appears to be safe. Despite the small sample, strong trends were identified for reduction of occurrence, extent, and severity of adhesion recurrence and de novo adhesion formation.