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Clinical Trials/NL-OMON36351
NL-OMON36351CompletedPhase 4

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

KCI Europe Holding B.V.0 sites30 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)

Investigators

Sponsor
KCI Europe Holding B.V.

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