Clinical trial NCT00771407: Parastomal Reinforcement With Strattice
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parastomal Hernia
Keywords: Ostomy creation
Parastomal hernia
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
timeFrame: 24 months
Secondary outcomes:
measure: Stoma Complications
timeFrame: 30 days
measure: Stoma Complications
timeFrame: more than 1 month postoperatively
measure: Stoma Quality of Life
timeFrame: Serially over 24 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Los Angeles
country: United States
facility: Office of Dr Phillip Fleshner
state: California
city: Orange
country: United States
facility: University of California at Irvine
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland/Baltimore VA
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health - Butterworth Hospital
state: Michigan
city: St Paul
country: United States
facility: Colon and Rectal Surgery Associates Ltd
state: Minnesota
city: St Louis
country: United States
facility: Washington University School of Medicine - Barnes Jewish West
state: Missouri
city: Omaha
country: United States
facility: Colon & Rectal Surgery Inc
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York City
country: United States
facility: Mt Sinai Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Washington University, St Louis MO
name: James Fleshman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
citation: Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.