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

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

Detailed Description
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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.

Official Title
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A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula

Conditions
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Anal Fistula, Treatment, Postoperative Complications, Acellular Dermal Matrix

Intervention / Treatment
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* Procedure: acellular dermal matrix plug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| acellualr dermal matrix<br>patients treated with acellular dermal matrix plug | Procedure: acellular dermal matrix plug<br>* anal fistula treated with human acellular dermal matrix plug<br>* Other names: Ruinuo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications |  | 01/07/2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | 01/07/2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal fistula, acellular dermal matrix, treatment, postoperative complications, recurrence