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

Postoperative Complications Clinical Trial

Official title:

A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00951002
• Other study ID #: AF-HADM-01
• Status: Recruiting
• Phase: N/A
• First received: July 31, 2009
• Last updated: November 25, 2013
• Start date: July 2009
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Beijing Chao Yang Hospital
• Contact: Zhen Jun Wang, M.D.
• Phone: 86-013601393711
• Email: wang3zj[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acellular Dermal Matrix
• Anal Fistula
• Fistula
• Postoperative Complications
• Rectal Fistula
• Treatment

Intervention

Procedure:
• acellular dermal matrix plug
anal fistula treated with human acellular dermal matrix plug

Locations

Country	Name	City	State
China	Beijing Anorectal Hospital	Beijing	Beijing
China	Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	General Surgery, Beijing Chao Yang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The Central Hospital of China Aerospace Corporation	Beijing	Beijing
China	The Second Artillery General Hospital	Beijing	Beijing
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Second Affiliated Hospital of Medical College Shandong University	Jinan	Shandong
China	The 85th Hosptial of P.L.A	Shanghai	Shanghai
China	Shenyang Anorectal Hospital	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Hebei Children's Hospital	Shijiazhuang	Hebei
China	General Staff Hospital of Wuhan Iron and Steel (Group) Corp	Wuhan	Hubei

Sponsors (13)

Lead Sponsor

Collaborator

Zhen Jun Wang

Beijing Anorectal Hospital, Dongzhimen Hospital, Beijing, Hebei Children's Hospital, Peking University Third Hospital, Second Affiliated Hospital of Medical College Shandong University, Shandong Provincial Hospital, Shenyang Anorectal Hospital, Shenzhen People's Hospital, The 85th Hosptial of P.L.A, The Central Hospital of China Aerospace Corporation, The Second Artillery General Hospital, Wuhan Iron and Steel Workers' Hospital

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications		01/07/2011	Yes
Secondary	recurrence rate		01/07/2011	Yes