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Study Summary
No. 2007-0537:.......Gastrointestinal; Infection; Peritoneum; Surgical Procedure......Donald P. Baumann......Plastic Surgery
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Study Summary Title
Study Summary
Number:		2007-0537
Study Title:A Multicenter, Prospective, Observational Evaluation of Repair of Infected or Contaminated Hernias (RICH) using LTM (STRATTICE)
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Physician New Patient Referral
Name:Donald P. BaumannPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Plastic SurgeryReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-1247
Contact us about clinical trials
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General Information
Disease Group:Gastrointestinal
Infection
Peritoneum
Surgical Procedure		Supported By:LifeCELL, Corp.
Phase of Study:Phase IVReturn
Visit:		A total of nine (9) visits are required by the study. These are Baseline, Day
of Definitive Closure, Post-operative days 7, 14, 30, Months 3, 12 and 24.
Treatment
Agents:		Surgical DeviceHome Care:Subjects will be instructed by hospital personnel and/or research staff
regarding post-operative wound care, diet, and activities of daily living.
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		Average LOS is 5-7 days post-operatively. Subjects would only need to be
rehospitalized in the event of an adverse surgical outcome (i.e. infection
requiring removal of the LTM (STRATTICE™)) or other untoward medical event
requiring hospitalization.
Description/
Intervention:		The goal of this clinical research study is to look at how well a type of
surgical mesh called LTM (STRATTICE™) works in the hernia repair of patients
who already have a bacterial contamination or infection.
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Study Objectives / Outcomes
The purpose of this study is designed to provide the initial information regarding the clinical outcomes associated with LTM (STRATTICE™) use in repair of infected or contaminated abdominal incisional hernias. The use of LTM (STRATTICE™), a surgical mesh derived from porcine dermis, processed to remove hair, cells and cell components as well as other antigens, used to support native tissue or bridge absent tissue for the repair of contaminated or infected incisional hernias will be evaluated.

The primary objective of this study is to describe the clinical outcomes of abdominal incisional hernia repair with LTM (STRATTICE™) in contaminated or infected sites as measured by perioperative wound events, including the incidence of postoperative infection.

Secondary objectives include postoperative resumption of activities of daily living (ADL), ability to manage infection in situ, pain assessment, resource utilization and incidence of re-herniation at 24 months.
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Study Status Information
Study Activation / Registration Date:01/08/2008
IRB Review and Approval Date:09/27/2007
Study Type:Observational
Recruitment Status:Terminated
Projected Accrual:75
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Adult greater than or equal to 18 years of age.

2) Has need for open abdominal incisional hernia repair where: a) contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction witha bowel resection, or such contamination occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus or, b) infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh.

3) Has an estimated hernia size of greater than or equal to 9 cm squared by physical exam and repair performed using a single sheet of LTM (STRATTICE™) (20 cm x 20 cm).

4) SSI Classification of "Clean-Contaminated", "Contaminated", or "Dirty".

5) Able to return for all scheduled and required study visits.

6) Able to provide written informed consent for study participation.
Exclusion Criteria:1) Has an estimated area of defect less than 9 cm squared by physical exam or will need more than a single sheet of LTM (STRATTICE™) to obtain closure.

2) Will undergo laparoscopic hernia repair.

3) Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh.

4) Has a systemic infection at the time of repair.

5) Has chronic conditions: hepatic cirrhosis (with or without ascites), renal failure requiring hemo- or peritoneal dialysis, incomplete malignancy resection, or defined collagen disorder.

6) Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.

7) Bedridden or otherwise non-ambulatory.

8) ASA Class 4 or 5.

9) BMI greater than or equal to 40.

10) Has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.

11) Has condition(s) which preclude abdominal imaging at standard imaging facility.

12) Requires only temporary closure.

13) Will undergo staged repair in more than or equal to 45 days.

14) Has a life expectancy of less than 24 months.
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Links
Registration Number: NCT00617357
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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