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

M

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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