Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

NCT ID: NCT01044589

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-12-31

Brief Summary

The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.

Conditions

Fecal Incontinence; Anal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biodesign Tissue Repair Graft

Biodesign Tissue Repair Graft

Group Type: EXPERIMENTAL

Biodesign Tissue Repair Graft

Intervention Type: DEVICE

Biodesign Tissue Repair Graft reinforcement

Overlapping Sphincter Repair

Intervention Type: OTHER

Overlapping Sphincter Repair Alone

Overlapping Sphincter Repair

Control

Group Type: ACTIVE_COMPARATOR

Overlapping Sphincter Repair

Intervention Type: OTHER

Overlapping Sphincter Repair Alone

Interventions

Biodesign Tissue Repair Graft

Biodesign Tissue Repair Graft reinforcement

Intervention Type: DEVICE

Overlapping Sphincter Repair

Overlapping Sphincter Repair Alone

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female
• Age 18 years or older
• fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
• Fecal incontinence severity score of 10 or more
• Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria

• History of diabetes
• History of allergy to porcine derivatives
• History of infection in the anal area (abscess, fistula)
• History of inflammatory bowel disease
• History of hidradenitis suppurativa
• History of immunosuppression
• History of HIV positivity
• History of radiation to the study site within the last 12 months
• Patients who cannot travel to keep follow up appointments
• Patients who are prisoners
• Patients who are mentally handicapped
• Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
• Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
• Patients with a FIQL baseline score of ≤ 4
• Patients participating in another clinical trial for the same indication
• Patients unwilling to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

Massarat Zutshi

OTHER

Sponsor Role: lead

Responsible Party

Massarat Zutshi

Staff

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Massarat Zutshi, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-008

Identifier Type: -

Identifier Source: org_study_id