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

January 14, 2008
October 29, 2015
September 2007
December 2010   (final data collection date for primary outcome measure)
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.
Incidence of surgical site events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00617357 on ClinicalTrials.gov Archive Site
  • 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.
Resumption of activities of daily living [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
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)

*   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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00617357
LFC2007.02.01
No
Not Provided
Not Provided
LifeCell
LifeCell
Not Provided
Principal Investigator: Kamal Itani, MD Boston VA Healthcare System
LifeCell
October 2015

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