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

Massarat Zutshi

Status: Terminated

Conditions: Anal Incontinence; Fecal Incontinence

Treatments: Device: Biodesign Tissue Repair Graft; Other: Overlapping Sphincter Repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01044589

09-008

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

Biodesign Tissue Repair Graft

Experimental group

Description:

Biodesign Tissue Repair Graft

Treatment:

Device: Biodesign Tissue Repair Graft

Other: Overlapping Sphincter Repair

Overlapping Sphincter Repair

Active Comparator group

Description:

Control

Treatment:

Other: Overlapping Sphincter Repair