Repair of Infected or Contaminated Hernias

Hernia Clinical Trial

— RICH  

Official title:

A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) Using LTM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617357
• Other study ID #: LFC2007.02.01
• 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

• Hernia

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