Seprafilm® adhesion barrier: (2) a review of the clinical literature on intraabdominal use

Author:

Diamond Michael P.,Burns Ellen L.,Accomando Beverly,Mian Sadiqa,Holmdahl Lena

Abstract

AbstractThis study seeks to provide a review of the clinical data published as of July 2011 concerning the postsurgical adhesion barrier, Seprafilm (chemically modified hyaluronic acid and carboxymethylcelulose; Genzyme Corporation, Cambridge, MA). Included articles detail the application of Seprafilm for intraabdominal uses that have been approved (on-label) and those considered investigational (off-label) by the FDA. Medline and EMBASE Drugs and Pharmaceuticals databases were searched for all original clinical Seprafilm research published as of July 2011. All human Seprafilm intraabdominal clinical reports and studies, excluding those related to prosthetic mesh were included. Data extraction involved the systematic review of each article. The data synthesis is the summary of Seprafilm human intraabdominal clinical reports and studies describing safety and/or efficacy. The safety and efficacy of Seprafilm in reducing postoperative adhesions has been clearly demonstrated in abdominal and pelvic laparotomy. While reports have described the safe and successful use of Seprafilm following laparoscopy, pediatric laparotomy, and in patients with malignancy and/or infection, the safety and efficacy of Seprafilm use in these procedures has not been definitively established in randomized controlled trials.

Publisher

Springer Science and Business Media LLC

Subject

Obstetrics and Gynaecology,Surgery

Reference50 articles.

1. Genzyme Corporation C, MA. Seprafilm Adhesion Barrier package insert (U.S.)

2. Trew G, Pistofidis G, Pados G, Lower A et al (2011) Gynaecological endoscopic evaluation of 4% icodextrin solution: a European, multicenter, double-blind, randomized study of the efficacy and safety in the reduction of de novo adhesions after laparoscopic gynaecological surgery. Hum Reprod 26(8):2015–2027

3. Becker JM, Dayton MT, Fazio VW et al (1996) Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective, randomized, double-blind multicenter study. J Am Coll Surg 183(4):297–306

4. Diamond MP (1996) Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group. Fertil Steril 66(6):904–910

5. Fukushima T, Matsuo K, Kusunoki M et al (1999) Clinical Study of a sodium hyaluronate/carboxymethylcellulose anti-adhesion membrane in abdominal surgery. Surg Treatment 81:227–233

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