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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00617357
Other study ID # LFC2007.02.01
Secondary ID
Status Completed
Phase N/A
First received January 14, 2008
Last updated October 29, 2015
Start date September 2007
Est. completion date December 2010

Study information

Verified date October 2015
Source LifeCell
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
LTM (Strattice Reconstructive Tissue Matrix)
Surgical mesh

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
LifeCell

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Activities Assessment Scale (AAS) 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 No
Secondary Activities Assessment Scale (AAS) 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 No
Secondary Activities Assessment Scale (AAS) 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 No
Secondary Activities Assessment Scale (AAS) 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 No
Secondary Activities Assessment Scale (AAS) 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 No
Secondary Activities Assessment Scale (AAS) 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 No
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