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

July 5, 2017 updated by: Massarat Zutshi
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodesign Tissue Repair Graft
Device: Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft reinforcement
Other: Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone
Active Comparator: Overlapping Sphincter Repair
Control
Other: Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massarat Zutshi

Collaborators

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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