Skip to content

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00951002
Enrollment
1000
Registered
2009-08-03
Start date
2009-07-31
Completion date
2013-11-30
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acellular Dermal Matrix, Anal Fistula, Postoperative Complications, Treatment

Keywords

anal fistula, acellular dermal matrix, treatment, postoperative complications, recurrence

Brief summary

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

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.

Interventions

PROCEDUREacellular dermal matrix plug

anal fistula treated with human acellular dermal matrix plug

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
postoperative complications01/07/2011

Secondary

MeasureTime frame
recurrence rate01/07/2011

Countries

China

Contacts

Primary ContactZhen Jun Wang, M.D.
wang3zj@sohu.com86-013601393711
Backup ContactJia Gang Han, M.D.
wzhj611@163.com86-013522867841

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026