A Multicenter, Prospective, Single-Blind, Randomized, Controlled, Study of the Repair of Challenging Abdominal Wall Defects: Strattice TM in abdominal Wall Repair (StaR)
- Conditions
- abdominal wall defectshernia1000007310040795
- Registration Number
- NL-OMON36351
- Lead Sponsor
- KCI Europe Holding B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1) Adult (= > 18 years old)
2) Wirtten informed consent
3)Has need a surgical intervention of abdominal wall where:
a) The abdominal wall defect is considered to be (potentially) contaminated, but there is no manifest infection
b) Abdominal wall defect of a midline, transverse of Pfannenstiel incision
c) A significant abdominal wall defect of >= 3cm and < 22 cm in length (along axis of incision), and
d) In case of open abdomen (skin and fascia open), the viscera have been exposed no longer than 15 days
e) Is willing and able to return for all schedulded and required study visits
1) Has, at the time of Randomization (patient readay for abdominal wall closure)
a) severe systemic sepsis (demonstrable bacteremia and/or endotoxemia with hypo/hyperpyrexia, leukopenia/cytosis, tachypnea or hypocarbia, and/or tachycardia)
b) frank pus in the wound, a fistula that will not be closed at time of surgery or an intra-abdominal abscess in surgical area,
c) ongoing necrotizing pancreatitis, or
2) is on chronic immunosuppresive therapy, or other medication that influences wound healing
3) Requires only short-term closure (i.e. reentry is anticipated within the next week),
4) Requires a synthetic, non-absorbable mesh to close the abdominal wall defect
5) Is unable to undergo general anesthesia
6) Has serious medical risk factors involving any of the major organ systems such that the Investigator considers there to be serious risk of the subject not completing the study (e.g. AIDS or advanced cancer)
7) Is participating in another clinical study which may alter the postoperative healing response.
8) is unable to undergo on MRI scan (due to claustrophobia or other reasons)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint: Hernia occurance at Month 12</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br>- Re-operation for abdominal wall repair within 12 months of repair<br /><br>- Incidence of complications requiring intervention (medical or surgical),<br /><br>including occurrence of fascial dehiscence, wound infection and seroma, within<br /><br>the first 30 days after fascial repair,<br /><br>- Length of hospital stay and resource utilization (eg OR time, days in<br /><br>speciality care)<br /><br>- Mortality (all cause) at Day 30, Months 3, 6 and 12<br /><br>- Resumption of Activities of Daily Living (ADL) as measured by the Activities<br /><br>Assessment Scale, including return to work</p><br>