Prevention of Postoperative Abdominal Adhesions by a Novel, Glycerol/Sodium Hyaluronate/Carboxymethylcellulose-Based Bioresorbable Membrane: A Prospective, Randomized, Evaluator-Blinded Multicenter Study

• Published in: Diseases of the colon & rectum Vol. 48; no. 6; pp. 1130 - 1139
• Main Authors: Cohen, Zane, Senagore, Anthony J, Dayton, Merril T, Koruda, Mark J, Beck, David E, Wolff, Bruce G, Fleshner, Phillip R, Thirlby, Richard C, Ludwig, Kirk A, Larach, Sergio W, Weiss, Eric G, Bauer, Joel J, Holmdahl, Lena
• Format: Journal Article
• Language: English
• Published: Secaucus, NJ The ASCRS 01-06-2005; Springer; Lippincott Williams & Wilkins Ovid Technologies
• Subjects: Adjuvants, Immunologic - administration & dosage; Adolescent; Adult; Aged; Aged, 80 and over; Biocompatible Materials; Biological and medical sciences; Carboxymethylcellulose Sodium; Colonic Pouches; Female; Glycerol - administration & dosage; Humans; Hyaluronic Acid - administration & dosage; Ileostomy - adverse effects; Male; Medical sciences; Membranes, Artificial; Middle Aged; Peritoneal Diseases - etiology; Peritoneal Diseases - prevention & control; Proctocolectomy, Restorative - adverse effects; Prospective Studies; Severity of Illness Index; Single-Blind Method; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Tissue Adhesions - etiology; Tissue Adhesions - prevention & control; Treatment Outcome; Postoperative; Cellulose(carboxymethyl); Adhesions; Complications; Multicenter study; Glycerol; Omentum; Artificial membrane; Adhesion; Small intestine; Abdomen; Prevention; Sodium; Sodium hyaluronate; Complication; Membrane; Biomaterial; Randomized trial
• ISSN: 0012-3706; 1530-0358
• DOI: 10.1007/s10350-004-0954-8

INTRODUCTION:
METHODS:
RESULTS:Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose.
CONCLUSIONS: