Parastomal Hernia Prevention With Strattice - Full Text View

Sponsor:	LifeCell
Information provided by:	LifeCell
ClinicalTrials.gov Identifier:	NCT00771407

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.

Condition	Intervention	Phase
Parastomal Hernia	Device: Strattice Reconstructive Matrix Other: Standard ostomy creation	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay to Prevent Parastomal Hernia Formation in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

Resource links provided by NLM:

MedlinePlus related topics: Hernia Ostomy Surgery

U.S. FDA Resources

Further study details as provided by LifeCell:

Primary Outcome Measures:

Occurrence of parastomal hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Stoma complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Stoma complications [ Time Frame: more than 1 month postoperatively ] [ Designated as safety issue: Yes ]
Stoma Quality of Life [ Time Frame: Serially over 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Strattice fascial inlay: Experimental Strattice will be placed as a fascial inlay to support the ostomy site	Device: Strattice Reconstructive Matrix Strattice will be placed as a fascial inlay to support ostomy sites
Standard ostomy construction: Active Comparator Ostomy will be created in the standard fashion	Other: Standard ostomy creation Ostomy will be created as routinely performed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771407

Show 21 Study Locations

Sponsors and Collaborators

LifeCell

Investigators

Principal Investigator:

James Fleshman, MD

Washington University, St Louis MO

More Information

No publications provided

Responsible Party:	LifeCell Corporation ( Randi Rutan, Director of Clinical Operations )
Study ID Numbers:	LFC2008.01.01
Study First Received:	October 10, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00771407 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by LifeCell:

Ostomy creation
Parastomal hernia

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hernia

ClinicalTrials.gov processed this record on February 04, 2010