N/A
N=115
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
Hernia, Abdominal · Abdominal Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01268514 ↗Enrolled (actual)
115
Serious AEs
80.9%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery — 19; 66; 12; 73 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery |
19; 66; 12; 73 | — |
| SECONDARY Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence |
10; 61; 20; 10; 61; 20 | — |
| SECONDARY QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. |
3.6; 4.2; 3.7; 3.11; 2.6; 1.9 | — |
| SECONDARY Patient Satisfaction Questionnaire - Right Choice to Have Surgery |
58; 3; 5; 58; 1; 6 | — |
| SECONDARY Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome |
46; 16; 4; 0; 45; 16 | — |
| SECONDARY Number of Participants With Post-op Complications |
16; 18; 5; 15; 4; 8 | — |
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
Eligibility Criteria
Inclusion Criteria
Subjects who meet all of the following criteria will be eligible for study enrollment:
- 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
All subjects who meet any of the following criteria should not be enrolled into the study:
- 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
- Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
- Permacol™ used in pelvic floor reconstruction
Data sourced from ClinicalTrials.gov (NCT01268514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.