Anal FistulaNCT00951002
The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
An observational study of Anal Fistula and Treatment, run by Zhen Jun Wang at 13 sites in China.
Trial summary
The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anal Fistula, Treatment, Postoperative Complications
- What is being tested?
- acellular dermal matrix plug
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 13 sitesChina
- Study dates
- Jul 2009to Nov 2013
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized patients with complex anal fistula
Who may be able to join
- complex anal fistula
Who cannot join
- pregnancy or lactation
- with operation contraindication
- allergic constitution to heterogeneous protein
- complicated with tumor
- complicated with acute infection
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Beijing Anorectal Hospital
Beijing, Beijing Municipality, 100000
Chang Shun Wang, M.D.
Chang Shun Wang, M.D.
- Recruiting
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100000
Bao Ming Zhao, M.D.
Bao Ming Zhao, M.D.
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Chao Wen Chen, M.D., 86-013901038133
Chao Wen Chen, M.D.
- Recruiting
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, 100000
Li Yong Wang, M.D.
Li Yong Wang, M.D.
- Recruiting
The Second Artillery General Hospital
Beijing, Beijing Municipality, 100000
Ke Zhao, M.D., 86-013370120126
Ke Zhao, M.D.
- Recruiting
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020
Zhen Jun Wang, M.D., 86-013601393711, wang3zj@sohu.com
Jia Gang Han, M.D., 86-013522867841, hjg512@yahoo.com.cn
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250000
Xue Zhi Xin, M.D., 86-013553173016
Xue Zhi Xin, M.D.
- Recruiting
The Second Affiliated Hospital of Medical College Shandong University
Jinan, Shandong
Ke Ding, M.D.
Ke Ding, M.D.
- Recruiting
The 85th Hosptial of P.L.A
Shanghai, Shanghai Municipality, 200000
Min Kong', M.D.
Min Kong, M.D.
- Recruiting
Shenyang Anorectal Hospital
Shenyang, Liaoning, 110000
Xian Dong Zeng, M.D., 86-013940188858
Xian Dong Zeng, M.D.
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000
Xiao Dong Yang, M.D., 86-013602643196
Xiao Dong Yang, M.D.
- Recruiting
Hebei Children's Hospital
Shijiazhuang, Hebei, 050000
Li Ya Wang, M.D.
Li Ya Wang, M.D.
- Recruiting
General Staff Hospital of Wuhan Iron and Steel (Group) Corp
Wuhan, Hubei, 430000
Guang Wei Si Tu, M.D.
Guang Wei Si Tu, M.D.
About this study
Official title: 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
Read the 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.
- Being tested
- acellular dermal matrix plug
- Keywords
- anal fistula, acellular dermal matrix, treatment, postoperative complications, recurrence
- Medical subject headings
- Rectal Fistula, Postoperative Complications, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acellular dermal matrix plugProcedure or surgery
Also called Ruinuo
anal fistula treated with human acellular dermal matrix plug
| Study group | Role | What they receive |
|---|---|---|
| acellualr dermal matrix | patients treated with acellular dermal matrix plug Receives: Procedure: acellular dermal matrix plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications
Measured: 01/07/2011
Secondary outcomes (1)
recurrence rate
Measured: 01/07/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhen Jun Wang
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
- Investigators
- Zhen Jun Wang, M.D., Study chair, Beijing Chao Yang HospitalKe Ding, M.D., Principal investigator, Second Affiliated Hospital of Medical College Shandong UniversityChang Shun Wang, M.D., Principal investigator, Beijing Anorectal HospitalLi Yong Wang, M.D., Principal investigator, The Central Hospital of China Aerospace CorporationLi Ya Wang, M.D., Principal investigator, Children's Hospital of Hebei ProvinceMin Kong, M.D., Principal investigator, The 85th Hosptial of P.L.AXue Zhi Xin, M.D., Principal investigator, Shandong Provincial HospitalChao Wen Chen, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951002
- Sponsor's protocol ID
- AF-HADM-01
- Status last verified
- Nov 2013
- First submitted
- 31 Jul 2009
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han JG, Xu HM, Song WL, Jin ML, Gao JS, Wang ZJ, Yang XQ. Histologic analysis of acellular dermal matrix in the treatment of anal fistula in an animal model. J Am Coll Surg. 2009 Jun;208(6):1099-106. doi: 10.1016/j.jamcollsurg.2009.02.052. Epub 2009 Apr 24.
PubMed 19476898Song WL, Wang ZJ, Zheng Y, Yang XQ, Peng YP. An anorectal fistula treatment with acellular extracellular matrix: a new technique. World J Gastroenterol. 2008 Aug 14;14(30):4791-4. doi: 10.3748/wjg.14.4791.
PubMed 18720541