The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
1 other identifier
observational
1,000
1 country
13
Brief Summary
The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 31, 2009
CompletedFirst Posted
Study publicly available on registry
August 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 27, 2013
November 1, 2013
4.3 years
July 31, 2009
November 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative complications
01/07/2011
Secondary Outcomes (1)
recurrence rate
01/07/2011
Study Arms (1)
acellualr dermal matrix
patients treated with acellular dermal matrix plug
Interventions
anal fistula treated with human acellular dermal matrix plug
Eligibility Criteria
hospitalized patients with complex anal fistula
You may qualify if:
- complex anal fistula
You may not qualify if:
- pregnancy or lactation
- with operation contraindication
- allergic constitution to heterogeneous protein
- complicated with tumor
- complicated with acute infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhen Jun Wanglead
- Second Affiliated Hospital of Medical College Shandong Universitycollaborator
- Beijing Anorectal Hospitalcollaborator
- The Central Hospital of China Aerospace Corporationcollaborator
- Children's Hospital of Hebei Provincecollaborator
- The 85th Hosptial of P.L.Acollaborator
- Shandong Provincial Hospitalcollaborator
- Peking University Third Hospitalcollaborator
- Shenzhen People's Hospitalcollaborator
- The Second Artillery General Hospitalcollaborator
- Dongzhimen Hospital, Beijingcollaborator
- Shenyang Anorectal Hospitalcollaborator
- Wuhan Iron and Steel Workers' Hospitalcollaborator
Study Sites (13)
Beijing Anorectal Hospital
Beijing, Beijing Municipality, 100000, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, 100000, China
The Second Artillery General Hospital
Beijing, Beijing Municipality, 100000, China
General Surgery, Beijing Chao Yang Hospital
Beijing, Beijing Municipality, 100020, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000, China
Hebei Children's Hospital
Shijiazhuang, Hebei, 050000, China
General Staff Hospital of Wuhan Iron and Steel (Group) Corp
Wuhan, Hubei, 430000, China
Shenyang Anorectal Hospital
Shenyang, Liaoning, 110000, China
Shandong Provincial Hospital
Jinan, Shandong, 250000, China
The Second Affiliated Hospital of Medical College Shandong University
Jinan, Shandong, China
The 85th Hosptial of P.L.A
Shanghai, Shanghai Municipality, 200000, China
Related Publications (2)
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.
PMID: 19476898BACKGROUNDSong 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.
PMID: 18720541RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor and Chief of General Surgery
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 3, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 27, 2013
Record last verified: 2013-11