Clinical trial NCT00617357: Repair of Infected or Contaminated Hernias
Official title: A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: incisional hernia
abdominal hernia repair
Ventral incisional hernia repair
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.


Eligibility criteria: Inclusion Criteria:

* is an adult ≥18 years old.
* has need of open abdominal incisional repair of a contaminated or infected site
* has an estimated hernia size of \>9cm2 by physical exam

Exclusion Criteria:

* has a nidus of chronic colonization
* has a systemic infection at the time of repair.
* has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
* requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
* is bedridden or otherwise non-ambulatory.
* is ASA Class 4 or 5.
* has a BMI \>40.
* has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.

Primary outcomes:
measure: Incidence of Wound Events
timeFrame: Postoperatively up to 24 months
Secondary outcomes:
measure: Activities Assessment Scale (AAS)
timeFrame: Baseline
measure: Activities Assessment Scale (AAS)
timeFrame: 30 Days
measure: Activities Assessment Scale (AAS)
timeFrame: 3 Months
measure: Activities Assessment Scale (AAS)
timeFrame: 6 Months
measure: Activities Assessment Scale (AAS)
timeFrame: 12 Months
measure: Activities Assessment Scale (AAS)
timeFrame: 24 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California-San Diego Medical Center
state: California
city: New Haven
country: United States
facility: Hospital of St Rafael
state: Connecticut
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Columbia
country: United States
facility: University of Missouri-Columbia Medical Center
state: Missouri
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Manhasset
country: United States
facility: North Shore University Hospital-Long Island Jewish Health System
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
affiliation: Boston VA Healthcare System
name: Kamal Itani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14.