Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)

Study Overview
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Brief Summary
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The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

Detailed Description
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This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. crossed over) or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect [dehiscence, hernia repair or open abdomen], morbidity [POSSUM score] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups. The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality. Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.

Official Title
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A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

Conditions
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Hernia, Surgical Wound Dehiscence

Intervention / Treatment
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* Device: Strattice(TM) Reconstructive Tissue Matrix
* Procedure: Suture/suture with absorbable mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults (18years of age or older) who is able to provide written informed consent for study participation has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of >3cm and <22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open). Is willing and able to return for all scheduled & required study visit. Exclusion Criteria: at the time of randomization severe systemic sepsis frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area, ongoing necrotizing pancreatitis, Is on chronic immunosuppressive therapy, or other medication that influences wound healing requires only short-term temporary closure, requires a synthetic, non-absorbable mesh to close the abdominal wall defect is unable to undergo general anesthesia, has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study. Is unable to undergo an MRI scan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Strattice(TM) TM repair<br>Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect | Device: Strattice(TM) Reconstructive Tissue Matrix<br>* Strattice(TM) TM will be used to support the repair of abdominal wall defect<br>|
| Active Comparator: Standard of Care repair<br>Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh | Procedure: Suture/suture with absorbable mesh<br>* Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Occurrence | Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained. | Month 12 after repair | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh