• Re-operation for abdominal wall repair [ Time Frame: within 12 months of repair ] [ Designated as safety issue: Yes ]
  need for reoperation to re-repair the original defect
• Incidence of acute complications requiring intervention (medical or surgical) [ Time Frame: First 30 days post-repair ] [ Designated as safety issue: Yes ]
  Incidence of complications requiring intervention (medical or surgical), including occurrence of fascial dehiscence, wound infection and seroma

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.

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.

• Hernia
• Surgical Wound Dehiscence

• Device: Strattice(TM) Reconstructive Tissue Matrix
  Strattice(TM) TM will be used to support the repair of abdominal wall defect
• Procedure: Suture/suture with absorbable mesh
  Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

• Active Comparator: Strattice(TM) TM repair
  Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
  Intervention: Device: Strattice(TM) Reconstructive Tissue Matrix
• Active Comparator: Standard of Care repair
  Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
  Intervention: Procedure: Suture/suture with absorbable mesh

• Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
• van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
• Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
• Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61.
• Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7.

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