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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Second Affiliated Hospital of Medical College Shandong University
Beijing Anorectal Hospital
The Central Hospital of China Aerospace Corporation
Children's Hospital of Hebei Province
The 85th Hosptial of P.L.A
Shandong Provincial Hospital
Peking University Third Hospital
Shenzhen People's Hospital
The Second Artillery General Hospital
Dongzhimen Hospital, Beijing
Shenyang Anorectal Hospital
Wuhan Iron and Steel Workers' Hospital
Information provided by (Responsible Party):
Zhen Jun Wang, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT00951002
First received: July 31, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose
The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

Condition Intervention
Anal Fistula
Treatment
Postoperative Complications
Acellular Dermal Matrix
Procedure: acellular dermal matrix plug

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula

Resource links provided by NLM:


Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 01/07/2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • recurrence rate [ Time Frame: 01/07/2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: July 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Ruinuo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
hospitalized patients with complex anal fistula
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951002

Locations
China, Beijing
Beijing Anorectal Hospital
Beijing, Beijing, China, 100000
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing, China, 100000
Peking University Third Hospital
Beijing, Beijing, China, 100000
The Central Hospital of China Aerospace Corporation
Beijing, Beijing, China, 100000
The Second Artillery General Hospital
Beijing, Beijing, China, 100000
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing, China, 100020
China, Guangdong
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518000
China, Hebei
Hebei Children's Hospital
Shijiazhuang, Hebei, China, 050000
China, Hubei
General Staff Hospital of Wuhan Iron and Steel (Group) Corp
Wuhan, Hubei, China, 430000
China, Liaoning
Shenyang Anorectal Hospital
Shenyang, Liaoning, China, 110000
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250000
The Second Affiliated Hospital of Medical College Shandong University
Jinan, Shandong, China
China, Shanghai
The 85th Hosptial of P.L.A
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Zhen Jun Wang
Second Affiliated Hospital of Medical College Shandong University
Beijing Anorectal Hospital
The Central Hospital of China Aerospace Corporation
Children's Hospital of Hebei Province
The 85th Hosptial of P.L.A
Shandong Provincial Hospital
Peking University Third Hospital
Shenzhen People's Hospital
The Second Artillery General Hospital
Dongzhimen Hospital, Beijing
Shenyang Anorectal Hospital
Wuhan Iron and Steel Workers' Hospital
Investigators
Study Chair: Zhen Jun Wang, M.D. Beijing Chao Yang Hospital, Capital Medical University
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
  More Information

Publications:
Responsible Party: Zhen Jun Wang, Professor and Chief of General Surgery, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT00951002     History of Changes
Other Study ID Numbers: AF-HADM-01 
Study First Received: July 31, 2009
Last Updated: November 25, 2013
Health Authority: China: Ministry of Health

Keywords provided by Beijing Chao Yang Hospital:
anal fistula
acellular dermal matrix
treatment
postoperative complications
recurrence

Additional relevant MeSH terms:
Fistula
Postoperative Complications
Rectal Fistula
Pathological Conditions, Anatomical
Pathologic Processes
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on December 09, 2016