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

November 25, 2013 updated by: Zhen Jun Wang

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhen Jun Wang, M.D.
  • Phone Number: 86-013601393711
  • Email: wang3zj@sohu.com

Study Contact Backup

  • Name: Jia Gang Han, M.D.
  • Phone Number: 86-013522867841
  • Email: wzhj611@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Chao Wen Chen, M.D.
          • Phone Number: 86-013901038133
        • Principal Investigator:
          • Chao Wen Chen, M.D.
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Anorectal Hospital
        • Contact:
          • Chang Shun Wang, M.D.
        • Principal Investigator:
          • Chang Shun Wang, M.D.
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
        • Contact:
          • Bao Ming Zhao, M.D.
        • Principal Investigator:
          • Bao Ming Zhao, M.D.
      • Beijing, Beijing, China, 100000
        • Recruiting
        • The Central Hospital of China Aerospace Corporation
        • Contact:
          • Li Yong Wang, M.D.
        • Principal Investigator:
          • Li Yong Wang, M.D.
      • Beijing, Beijing, China, 100000
        • Recruiting
        • The Second Artillery General Hospital
        • Contact:
          • Ke Zhao, M.D.
          • Phone Number: 86-013370120126
        • Principal Investigator:
          • Ke Zhao, M.D.
      • Beijing, Beijing, China, 100020
        • Recruiting
        • General Surgery, Beijing Chao Yang Hospital
        • Contact:
        • Sub-Investigator:
          • Wei Liang Song, M.D.
        • Contact:
        • Principal Investigator:
          • Zhen Jun Wang, M.D.
        • Sub-Investigator:
          • Jia Gang Han, M.D.
        • Sub-Investigator:
          • Yi Zheng, M.D.
        • Sub-Investigator:
          • Hua Chong Ma, M.D.
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
          • Xiao Dong Yang, M.D.
          • Phone Number: 86-013602643196
        • Principal Investigator:
          • Xiao Dong Yang, M.D.
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • Hebei Children's Hospital
        • Contact:
          • Li Ya Wang, M.D.
        • Principal Investigator:
          • Li Ya Wang, M.D.
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • General Staff Hospital of Wuhan Iron and Steel (Group) Corp
        • Contact:
          • Guang Wei Si Tu, M.D.
        • Principal Investigator:
          • Guang Wei Si Tu, M.D.
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Shenyang Anorectal Hospital
        • Contact:
          • Xian Dong Zeng, M.D.
          • Phone Number: 86-013940188858
        • Principal Investigator:
          • Xian Dong Zeng, M.D.
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Xue Zhi Xin, M.D.
          • Phone Number: 86-013553173016
        • Principal Investigator:
          • Xue Zhi Xin, M.D.
      • Jinan, Shandong, China
        • Recruiting
        • The Second Affiliated Hospital of Medical College Shandong University
        • Contact:
          • Ke Ding, M.D.
        • Principal Investigator:
          • Ke Ding, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • The 85th Hosptial of P.L.A
        • Contact:
          • Min Kong', M.D.
        • Principal Investigator:
          • Min Kong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

hospitalized patients with complex anal fistula

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
acellualr dermal matrix
patients treated with acellular dermal matrix plug
Procedure: acellular dermal matrix plug
anal fistula treated with human acellular dermal matrix plug
Other Names:
  • Ruinuo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative complications
Time Frame: 01/07/2011
01/07/2011

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence rate
Time Frame: 01/07/2011
01/07/2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhen Jun Wang

Collaborators

Peking University Third Hospital
Shandong Provincial Hospital
Shenzhen People's Hospital
Dongzhimen Hospital, Beijing
Children's Hospital of Hebei Province
The Second Artillery General Hospital
Beijing Anorectal Hospital
Second Affiliated Hospital of Medical College Shandong University
The Central Hospital of China Aerospace Corporation
The 85th Hosptial of P.L.A
Shenyang Anorectal Hospital
Wuhan Iron and Steel Workers' Hospital

Investigators

  • Study Chair: Zhen Jun Wang, M.D., Beijing Chao Yang Hospital
  • Principal Investigator: Ke Ding, M.D., Second Affiliated Hospital of Medical College Shandong University
  • Principal Investigator: Chang Shun Wang, M.D., Beijing Anorectal Hospital
  • Principal Investigator: Li Yong Wang, M.D., The Central Hospital of China Aerospace Corporation
  • Principal Investigator: Li Ya Wang, M.D., Children's Hospital of Hebei Province
  • Principal Investigator: Min Kong, M.D., The 85th Hosptial of P.L.A
  • Principal Investigator: Xue Zhi Xin, M.D., Shandong Provincial Hospital
  • Principal Investigator: Chao Wen Chen, M.D., Peking University Third Hospital
  • Principal Investigator: Xiao Dong Yang, M.D., ShenZhen People's Hospital
  • Principal Investigator: Ke Zhao, M.D., The Second Artillery General Hospital
  • Principal Investigator: Bao Ming Zhao, M.D., Dongzhimen Hospital, Beijing
  • Principal Investigator: Xian Dong Zeng, M.D., Shenyang Anorectal Hospital
  • Principal Investigator: Si Tu Guang Wei, M.D., Wuhan Iron and Steel Workers' Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

July 31, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF-HADM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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