Parastomal Reinforcement With Strattice

Trial ID or NCT#

NCT00771407

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Official Title

A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - adults - need for permanent ileostomy or colostomy
Exclusion Criteria:
  1. - history of hernia at new ostomy site - has previously implanted surgical mesh at site of planned ostomy - requires a temporary ostomy - has need for multiple ostomies - is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder - is bedridden or otherwise non-ambulatory
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Investigator(s)

Andrew A. Shelton, MD, FACS, FACRS
Andrew A. Shelton, MD, FACS, FACRS
Colorectal surgeon
Clinical Professor, Surgery - General Surgery

Contact us to find out if this trial is right for you.

Contact

Moe Jalali
6507244023

View on ClinicalTrials.gov