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OpenTrials
Completed

NCT Number: NCT00771407

Parastomal Reinforcement With Strattice

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.

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Key information

Conditions

Parastomal Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of South Alabama, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults
  • need for permanent ileostomy or colostomy

Exclusion criteria

  • 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

Treatment and study plan

Strattice Reconstructive Matrix

Device

Strattice will be placed as a fascial inlay to support stoma sites

Standard ostomy creation

Other

Ostomy will be created as routinely performed

Primary outcomes

  1. Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.

    Time frame: 24 months

Secondary outcomes

  1. Stoma Complications

    Time frame: 30 days

  2. Stoma Complications

    Time frame: more than 1 month postoperatively

  3. Stoma Quality of Life

    Time frame: Serially over 24 months

Sponsors and collaborators

Lead sponsor

LifeCell

Industry

Registry information

Official study 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

Acronym: PriSm

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2008
Registry last updated
Sep 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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