Hernia Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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