CompletedNot Applicable

ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs

Belgium, Germany, Italy115 participantsStarted 2011-02

Plain-language summary

The objective of this prospective study is to evaluate short-term, mid-term, and long-term clinical outcomes associated with the use of Permacol™ Biological Implant in the treatment of complex abdominal wall defects

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subjects who are 18 years of age and older
✓. Subjects of either sex
✓. Subjects who require complex abdominal repair using Permacol™ Biological Implant.
✓. Subjects who are willing and able to adhere to protocol requirements and provide written informed consent

Exclusion criteria

✕. Subjects who are pregnant
✕. Subjects with a medical condition that in the opinion of the investigator may preclude participation (e.g. Ehlers Danlos Syndrome) or interfere with completion of study follow-up
✕. Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
✕. Concomitant use of a synthetic or another biologic mesh
✕. Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
✕. Subject who has systemic sepsis at the time of Permacol™ implantation
✕. Subject with ongoing necrotizing pancreatitis
✕. Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair

What they're measuring

Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery

Timeframe: 36 months post-surgery

Trial details

NCT IDNCT01268514

SponsorMedtronic - MITG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-11

Results submitted2017-11-15

View on ClinicalTrials.gov More Hernia, Abdominal trials