Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required.

METHODS/DESIGN:

The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period.

DISCUSSION:

To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas.

TRIAL REGISTRATION:

NCT01828892 . Registration date: April 2013.

• Authors: Xiuwen Wu, Jianan Ren, Gefei Wang, Jianzhong Wang, Feng Wang, Yueping Fan, Yuanxin Li, Gang Han, Yanbing Zhou, Xiaofei Song, Bin Quan, Min Yao, Jieshou Li
• Journal: Trials (Trials) Vol. 16 Pg. 445 (Oct 07 2015) ISSN: 1745-6215 [Electronic] England
• PMID: 26445823 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrin Tissue Adhesive
• Tissue Adhesives

Topics

• China
• Clinical Protocols
• Cutaneous Fistula (diagnosis, therapy)
• Fibrin Tissue Adhesive (adverse effects, therapeutic use)
• Humans
• Intestinal Fistula (diagnosis, therapy)
• Prospective Studies
• Research Design
• Time Factors
• Tissue Adhesives (adverse effects, therapeutic use)
• Treatment Outcome