Completed PHASE4 INTERVENTIONAL 2-arm NCT00771407

Parastomal Reinforcement With Strattice (PriSm)

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

Sponsor: LifeCell

Conditions Parastomal Hernia

Interventions Standard ostomy creation Strattice Reconstructive Matrix

Updated 9 times since 2017 Last updated: Aug 25, 2015 Started: Dec 31, 2008 Primary completion: Feb 29, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00771407, this PHASE4 trial focuses on Parastomal Hernia and remains completed. Sponsored by LifeCell, it has been updated 9 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2023 — Jul 2024 [monthly]

Completed PHASE4
Dec 2022 — Jan 2023 [monthly]

Completed PHASE4

▶ Show 4 earlier versions

Jan 2021 — Dec 2022 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Dec 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

LifeCell

Data source: LifeCell

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albany, United States , Baltimore, United States , Burlington, United States , Chicago, United States , Cincinnati, United States , Cleveland, United States , Durham, United States , Grand Rapids, United States , Houston, United States , Indianapolis, United States and 12 more locations