Repair of Infected or Contaminated Hernias
RICH
A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM
1 other identifier
interventional
83
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
December 1, 2015
CompletedDecember 1, 2015
October 1, 2015
3.3 years
January 14, 2008
August 16, 2012
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Wound Events
Wound Events are defined as those events which occurred in the area of the hernia repair and the repair site, including seroma, hematoma, dehiscence, infection, abscess, fistula, and re-herniation.
Postoperatively up to 24 months
Secondary Outcomes (6)
Activities Assessment Scale (AAS)
Baseline
Activities Assessment Scale (AAS)
30 Days
Activities Assessment Scale (AAS)
3 Months
Activities Assessment Scale (AAS)
6 Months
Activities Assessment Scale (AAS)
12 Months
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALStrattice Reconstructive Tissue Matrix
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeCelllead
Study Sites (15)
University of California-San Diego Medical Center
La Jolla, California, United States
Hospital of St Rafael
New Haven, Connecticut, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70121, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
University of Missouri-Columbia Medical Center
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
North Shore University Hospital-Long Island Jewish Health System
Manhasset, New York, 11030, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Related Publications (2)
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.
PMID: 22763262RESULTRosen 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.
PMID: 22415440DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Michael Franz
- Organization
- LifeCell
Study Officials
- PRINCIPAL INVESTIGATOR
Kamal Itani, MD
Boston VA Healthcare System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2008
First Posted
February 18, 2008
Study Start
September 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
December 1, 2015
Results First Posted
December 1, 2015
Record last verified: 2015-10