Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) (StAR)
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|ClinicalTrials.gov Identifier: NCT01083472|
Recruitment Status : Terminated (Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.)
First Posted : March 9, 2010
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hernia Surgical Wound Dehiscence||Device: Strattice(TM) Reconstructive Tissue Matrix Procedure: Suture/suture with absorbable mesh||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
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
Device: Strattice(TM) Reconstructive Tissue Matrix
Strattice(TM) TM will be used to support the repair of abdominal wall defect
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
Procedure: Suture/suture with absorbable mesh
Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
- Hernia Occurrence [ Time Frame: Month 12 after repair ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083472
|Principal Investigator:||Angus JM Watson||Raigmore Hospital, Inverness Scotland, National Health Service, UK|
|Principal Investigator:||Berndt Reith||Klinikum Konstanz, Konstanz Germany|
|Study Chair:||Johannes Jeekel|