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.


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


METHODS
Gynecologic practices.


METHODS
Thirty-four patients were enrolled; 17 in each group were available for the safety analysis and 16 for the efficacy analysis.


METHODS
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.


METHODS
Safety and postoperative adhesion formation.


RESULTS
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.


CONCLUSIONS
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.
Diamond
Michael P
MP
Wayne State University/Detroit Medical Center, Detroit, Michigan, USA. mdiamond@med.wayne.edu
Luciano
Anthony
A
Johns
D Alan
DA
Dunn
Randall
R
Young
Phillip
P
Bieber
Eric
E
D000328:Adult; D002686:Chitin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D048271:Chitosan; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects*; D010865:Pilot Projects; D012008:Recurrence; D012720:Severity of Illness Index; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control*
C077199:O,N-carboxymethylchitosan; D002686:Chitin; D048271:Chitosan