Repair of Infected or Contaminated Hernias (RICH)

October 29, 2015 updated by: LifeCell

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States
        • University of California-San Diego Medical Center
    • Connecticut
      • New Haven, Connecticut, United States
        • Hospital of St Rafael
    • Louisiana
      • New Orleans, Louisiana, United States
        • Tulane University Medical Center
      • New Orleans, Louisiana, United States, 70121
        • Louisiana State University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Medical Center
    • Missouri
      • Columbia, Missouri, United States
        • University of Missouri-Columbia Medical Center
      • St Louis, Missouri, United States
        • Washington University
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital-Long Island Jewish Health System
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina Hospitals
    • Ohio
      • Cleveland, Ohio, United States
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine
      • Houston, Texas, United States
        • University of Texas - MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States
        • University of Utah Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Strattice Reconstructive Tissue Matrix
Device: LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Wound Events
Time Frame: Postoperatively up to 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities Assessment Scale (AAS)
Time Frame: Baseline
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.
Baseline
Activities Assessment Scale (AAS)
Time Frame: 30 Days
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.
30 Days
Activities Assessment Scale (AAS)
Time Frame: 3 Months
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.
3 Months
Activities Assessment Scale (AAS)
Time Frame: 6 Months
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.
6 Months
Activities Assessment Scale (AAS)
Time Frame: 12 Months
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.
12 Months
Activities Assessment Scale (AAS)
Time Frame: 24 Months
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.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeCell

Investigators

  • Principal Investigator: Kamal Itani, MD, Boston VA Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (ESTIMATE)

February 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFC2007.02.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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