Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00951002
Status:
UNKNOWN
Last Update Posted:
2013-11-27
First Post:
2009-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2009-07-31', 'studyFirstSubmitQcDate': '2009-07-31', 'lastUpdatePostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '01/07/2011'}], 'secondaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': '01/07/2011'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anal fistula', 'acellular dermal matrix', 'treatment', 'postoperative complications', 'recurrence'], 'conditions': ['Anal Fistula', 'Treatment', 'Postoperative Complications', 'Acellular Dermal Matrix']}, 'referencesModule': {'references': [{'pmid': '19476898', 'type': 'BACKGROUND', 'citation': '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': '18720541', 'type': 'RESULT', 'citation': 'Song 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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula', 'detailedDescription': '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.\n\nHuman 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.\n\nThe purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized patients with complex anal fistula', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complex anal fistula\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* with operation contraindication\n* allergic constitution to heterogeneous protein\n* complicated with tumor\n* complicated with acute infection'}, 'identificationModule': {'nctId': 'NCT00951002', 'briefTitle': 'The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula', 'orgStudyIdInfo': {'id': 'AF-HADM-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acellualr dermal matrix', 'description': 'patients treated with acellular dermal matrix plug', 'interventionNames': ['Procedure: acellular dermal matrix plug']}], 'interventions': [{'name': 'acellular dermal matrix plug', 'type': 'PROCEDURE', 'otherNames': ['Ruinuo'], 'description': 'anal fistula treated with human acellular dermal matrix plug', 'armGroupLabels': ['acellualr dermal matrix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang Shun Wang, M.D.', 'role': 'CONTACT'}, {'name': 'Chang Shun Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Anorectal Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bao Ming Zhao, M.D.', 'role': 'CONTACT'}, {'name': 'Bao Ming Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Wen Chen, M.D.', 'role': 'CONTACT', 'phone': '86-013901038133'}, {'name': 'Chao Wen Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Yong Wang, M.D.', 'role': 'CONTACT'}, {'name': 'Li Yong Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Central Hospital of China Aerospace Corporation', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Zhao, M.D.', 'role': 'CONTACT', 'phone': '86-013370120126'}, {'name': 'Ke Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Artillery General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhen Jun Wang, M.D.', 'role': 'CONTACT', 'email': 'wang3zj@sohu.com', 'phone': '86-013601393711'}, {'name': 'Jia Gang Han, M.D.', 'role': 'CONTACT', 'email': 'hjg512@yahoo.com.cn', 'phone': '86-013522867841'}, {'name': 'Zhen Jun Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jia Gang Han, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wei Liang Song, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yi Zheng, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hua Chong Ma, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'General Surgery, Beijing Chao Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Dong Yang, M.D.', 'role': 'CONTACT', 'phone': '86-013602643196'}, {'name': 'Xiao Dong Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Ya Wang, M.D.', 'role': 'CONTACT'}, {'name': 'Li Ya Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hebei Children's Hospital", 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang Wei Si Tu, M.D.', 'role': 'CONTACT'}, {'name': 'Guang Wei Si Tu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Staff Hospital of Wuhan Iron and Steel (Group) Corp', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xian Dong Zeng, M.D.', 'role': 'CONTACT', 'phone': '86-013940188858'}, {'name': 'Xian Dong Zeng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shenyang Anorectal Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xue Zhi Xin, M.D.', 'role': 'CONTACT', 'phone': '86-013553173016'}, {'name': 'Xue Zhi Xin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Provincial Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Ding, M.D.', 'role': 'CONTACT'}, {'name': 'Ke Ding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Medical College Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': "Min Kong', M.D.", 'role': 'CONTACT'}, {'name': 'Min Kong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 85th Hosptial of P.L.A', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhen Jun Wang, M.D.', 'role': 'CONTACT', 'email': 'wang3zj@sohu.com', 'phone': '86-013601393711'}, {'name': 'Jia Gang Han, M.D.', 'role': 'CONTACT', 'email': 'wzhj611@163.com', 'phone': '86-013522867841'}], 'overallOfficials': [{'name': 'Zhen Jun Wang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Chao Yang Hospital'}, {'name': 'Ke Ding, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Medical College Shandong University'}, {'name': 'Chang Shun Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Anorectal Hospital'}, {'name': 'Li Yong Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Central Hospital of China Aerospace Corporation'}, {'name': 'Li Ya Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Hebei Province"}, {'name': 'Min Kong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 85th Hosptial of P.L.A'}, {'name': 'Xue Zhi Xin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Provincial Hospital'}, {'name': 'Chao Wen Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Xiao Dong Yang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shenzhen People's Hospital"}, {'name': 'Ke Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Artillery General Hospital'}, {'name': 'Bao Ming Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongzhimen Hospital, Beijing'}, {'name': 'Xian Dong Zeng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Anorectal Hospital'}, {'name': 'Si Tu Guang Wei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Wuhan Iron and Steel Workers' Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhen Jun Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Medical College Shandong University', 'class': 'OTHER'}, {'name': 'Beijing Anorectal Hospital', 'class': 'OTHER'}, {'name': 'The Central Hospital of China Aerospace Corporation', 'class': 'UNKNOWN'}, {'name': "Children's Hospital of Hebei Province", 'class': 'OTHER'}, {'name': 'The 85th Hosptial of P.L.A', 'class': 'UNKNOWN'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': "Shenzhen People's Hospital", 'class': 'OTHER'}, {'name': 'The Second Artillery General Hospital', 'class': 'OTHER'}, {'name': 'Dongzhimen Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Shenyang Anorectal Hospital', 'class': 'OTHER'}, {'name': "Wuhan Iron and Steel Workers' Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief of General Surgery', 'investigatorFullName': 'Zhen Jun Wang', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}