The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
This study is currently recruiting participants.
Verified February 2012 by Beijing Chao Yang Hospital
Sponsor:
Zhen Jun Wang
Collaborators:
Second Affiliated Hospital of Medical College Shandong University
Beijing Anorectal Hospital
The Central Hospital of China Aerospace Corporation
Hebei Children's Hospital
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 Affiliated to Beijing University of Chinese Medicine
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: February 1, 2012
Last verified: February 2012
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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: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951002
Contacts
| Contact: Zhen Jun Wang, M.D. | 86-013601393711 | wang3zj@sohu.com |
| Contact: Jia Gang Han, M.D. | 86-013522867841 | wzhj611@163.com |
Locations
| China, Beijing | |
| General Surgery, Beijing Chao Yang Hospital | Recruiting |
| Beijing, Beijing, China, 100020 | |
| Contact: Zhen Jun Wang, M.D. 86-013601393711 wang3zj@sohu.com | |
| Contact: Jia Gang Han, M.D. 86-013522867841 hjg512@yahoo.com.cn | |
| Principal Investigator: Zhen Jun Wang, M.D. | |
| Sub-Investigator: Jia Gang Han, M.D. | |
| Sub-Investigator: Wei Liang Song, M.D. | |
| Sub-Investigator: Yi Zheng, M.D. | |
| Sub-Investigator: Hua Chong Ma, M.D. | |
| Peking University Third Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Chao Wen Chen, M.D. 86-013901038133 | |
| Principal Investigator: Chao Wen Chen, M.D. | |
| The Second Artillery General Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Ke Zhao, M.D. 86-013370120126 | |
| Principal Investigator: Ke Zhao, M.D. | |
| Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Bao Ming Zhao, M.D. | |
| Principal Investigator: Bao Ming Zhao, M.D. | |
| The Central Hospital of China Aerospace Corporation | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Li Yong Wang, M.D. | |
| Principal Investigator: Li Yong Wang, M.D. | |
| Beijing Anorectal Hospital | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Contact: Chang Shun Wang, M.D. | |
| Principal Investigator: Chang Shun Wang, M.D. | |
| China, Guangdong | |
| Shenzhen People's Hospital | Recruiting |
| Shenzhen, Guangdong, China, 518000 | |
| Contact: Xiao Dong Yang, M.D. 86-013602643196 | |
| Principal Investigator: Xiao Dong Yang, M.D. | |
| China, Hebei | |
| Hebei Children's Hospital | Recruiting |
| Shijiazhuang, Hebei, China, 050000 | |
| Contact: Li Ya Wang, M.D. | |
| Principal Investigator: Li Ya Wang, M.D. | |
| China, Hubei | |
| General Staff Hospital of Wuhan Iron and Steel (Group) Corp | Recruiting |
| Wuhan, Hubei, China, 430000 | |
| Contact: Guang Wei Si Tu, M.D. | |
| Principal Investigator: Guang Wei Si Tu, M.D. | |
| China, Liaoning | |
| Shenyang Anorectal Hospital | Recruiting |
| Shenyang, Liaoning, China, 110000 | |
| Contact: Xian Dong Zeng, M.D. 86-013940188858 | |
| Principal Investigator: Xian Dong Zeng, M.D. | |
| China, Shandong | |
| The Second Affiliated Hospital of Medical College Shandong University | Recruiting |
| Jinan, Shandong, China | |
| Contact: Ke Ding, M.D. | |
| Principal Investigator: Ke Ding, M.D. | |
| Shandong Provincial Hospital | Recruiting |
| Jinan, Shandong, China, 250000 | |
| Contact: Xue Zhi Xin, M.D. 86-013553173016 | |
| Principal Investigator: Xue Zhi Xin, M.D. | |
| China, Shanghai | |
| The 85th Hosptial of P.L.A | Recruiting |
| Shanghai, Shanghai, China, 200000 | |
| Contact: Min Kong`, M.D. | |
| Principal Investigator: Min Kong, M.D. | |
Sponsors and Collaborators
Zhen Jun Wang
Second Affiliated Hospital of Medical College Shandong University
Beijing Anorectal Hospital
The Central Hospital of China Aerospace Corporation
Hebei Children's Hospital
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 Affiliated to Beijing University of Chinese Medicine
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. | Hebei Children's Hospital |
| 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 Affiliated to Beijing University of Chinese Medicine |
| 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: | February 1, 2012 |
| 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 June 13, 2013