The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula

• Conditions: Treatment; Postoperative Complications; Anal Fistula; Acellular Dermal Matrix
• Interventions: Procedure: acellular dermal matrix plug

• Registration Number: NCT00951002
• Lead Sponsor: Zhen Jun Wang

Brief Summary

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

Detailed Description

Recently, the use of biomaterial for the treatment of anal fistula has drawn great interest. The advantages of this technique include simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and the ability for subsequent surgical options if needed. Champagne et al reported using a biologic absorbable anal fistula plug which is made from lyophilized porcine small intestinal submucosa (Surgisis®). In their series of 46 patients treated with the anal fistula plug, a success rate of 83 percent was achieved at a median follow-up of 12 months. In addition, evaluation of the functional outcome after fistula closure showed no impairment of continence with significant improvement in quality of life showed. However, the long term success rates of Surgisis® are variable according to other studies.

Human acellular dermal matrix (ADM) is a biologic material consists of dermis without its cellular components. Early and rapid revascularization of the implanted ADM, as was shown in our previous experimental study, is thought to enhance resistance to infection and contamination. These properties make ADM an attractive alternative for the treatment of anal fistula. The ability of ADM to become vascularized and remodeled by autologous cells may be advantageous for anal fistulas healing.

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-31
• Study First Submitted QC: 2009-07-31
• Study First Posted: 2009-08-03
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• complex anal fistula

Exclusion Criteria

• pregnancy or lactation
• with operation contraindication
• allergic constitution to heterogeneous protein
• complicated with tumor
• complicated with acute infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
acellualr dermal matrix	acellular dermal matrix plug	patients treated with acellular dermal matrix plug

Primary Outcome Measures

Name	Time	Method
postoperative complications	01/07/2011

Secondary Outcome Measures

Name	Time	Method
recurrence rate	01/07/2011

Trial Locations

Locations (13)

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The Central Hospital of China Aerospace Corporation; 🇨🇳 Beijing, Beijing, China

Beijing Anorectal Hospital; 🇨🇳 Beijing, Beijing, China

Hebei Children's Hospital; 🇨🇳 Shijiazhuang, Hebei, China

General Surgery, Beijing Chao Yang Hospital; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital of Medical College Shandong University; 🇨🇳 Jinan, Shandong, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

The Second Artillery General Hospital; 🇨🇳 Beijing, Beijing, China

General Staff Hospital of Wuhan Iron and Steel (Group) Corp; 🇨🇳 Wuhan, Hubei, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Shenyang Anorectal Hospital; 🇨🇳 Shenyang, Liaoning, China

The 85th Hosptial of P.L.A; 🇨🇳 Shanghai, Shanghai, China