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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-11-30

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.

Conditions

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Anal Fistula Treatment Postoperative Complications Acellular Dermal Matrix

Keywords

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anal fistula acellular dermal matrix treatment postoperative complications recurrence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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acellualr dermal matrix

patients treated with acellular dermal matrix plug

acellular dermal matrix plug

Intervention Type PROCEDURE

anal fistula treated with human acellular dermal matrix plug

Interventions

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acellular dermal matrix plug

anal fistula treated with human acellular dermal matrix plug

Intervention Type PROCEDURE

Other Intervention Names

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Ruinuo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhen Jun Wang

Professor and Chief of General Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhen Jun Wang, M.D.

Role: STUDY_CHAIR

Beijing Chao Yang Hospital

Ke Ding, M.D.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Medical College Shandong University

Chang Shun Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Anorectal Hospital

Li Yong Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of China Aerospace Corporation

Li Ya Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Hebei Province

Min Kong, M.D.

Role: PRINCIPAL_INVESTIGATOR

The 85th Hosptial of P.L.A

Xue Zhi Xin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Chao Wen Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Xiao Dong Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shenzhen People's Hospital

Ke Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Second Artillery General Hospital

Bao Ming Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital, Beijing

Xian Dong Zeng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shenyang Anorectal Hospital

Si Tu Guang Wei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wuhan Iron and Steel Workers' Hospital

Locations

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