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Repair of Infected or Contaminated Hernias (RICH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00617357
First received: January 14, 2008
Last updated: November 14, 2011
Last verified: November 2011
History of Changes

January 14, 2008
November 14, 2011
September 2007
December 2010   (final data collection date for primary outcome measure)
Incidence of surgical site events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00617357 on ClinicalTrials.gov Archive Site
Resumption of activities of daily living [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Repair of Infected or Contaminated Hernias
A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hernia
Device: LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh
Experimental: 1
Strattice Reconstructive Tissue Matrix
Intervention: Device: LTM (Strattice Reconstructive Tissue Matrix)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00617357
LFC2007.02.01
No
LifeCell
LifeCell
Not Provided
Principal Investigator: Kamal Itani, MD Boston VA Healthcare System
LifeCell
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP