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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: October 29, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Hernia
Device: LTM (Strattice Reconstructive Tissue Matrix)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

Resource links provided by NLM:


Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Incidence of Wound Events [ Time Frame: Postoperatively up to 24 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Activities Assessment Scale (AAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are numerically transformed to produce a range of 0-100, with higher values indicating greater functional activity.

  • Activities Assessment Scale (AAS) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

  • Activities Assessment Scale (AAS) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

  • Activities Assessment Scale (AAS) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

  • Activities Assessment Scale (AAS) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.

  • Activities Assessment Scale (AAS) [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    The AAS includes 13 items covering a broad sample of sedentary, movement-related and graded-intensity physical activities. Respondents are asked to rate the degree of difficulty performing each of these activities in the previous 24 hours on a 5-point scale from "No difficulty" to "Not able to do it." The AAS has three subscales: sedentary activities (items 1-4); ambulatory activities (items 6-8); work/exercise activities (items 11-13). The AAS total and subscale scores are transformed to produce a range of 0-100, with higher values indicating greater functional activity.


Enrollment: 83
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Strattice Reconstructive Tissue Matrix
Device: LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617357

Locations
United States, California
University of California-San Diego Medical Center
La Jolla, California, United States
United States, Connecticut
Hospital of St Rafael
New Haven, Connecticut, United States
United States, Louisiana
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70121
Tulane University Medical Center
New Orleans, Louisiana, United States
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States
United States, Missouri
University of Missouri-Columbia Medical Center
Columbia, Missouri, United States
Washington University
St Louis, Missouri, United States
United States, New York
North Shore University Hospital-Long Island Jewish Health System
Manhasset, New York, United States, 11030
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: Kamal Itani, MD Boston VA Healthcare System
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00617357     History of Changes
Other Study ID Numbers: LFC2007.02.01 
Study First Received: January 14, 2008
Results First Received: August 16, 2012
Last Updated: October 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by LifeCell:
incisional hernia
abdominal hernia repair
Ventral incisional hernia repair

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 30, 2016