Clinical trial NCT01268514: ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
Official title: ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Abdominal
Abdominal Injuries
Keywords: Complex
Abdominal Wall Reconstruction
AWR
Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-12-31
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who will undergo planned surgical treatment for complex abdominal wall repair with Permacol™ implantation and agree to 36 months of follow-up.

Brief 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

Detailed description: This will be a prospective, multi-centre, non-randomized study to collect post-market clinical data on Permacol™ Biological Implant following complex abdominal wall repair (including abdominal wall defects and fascial dehiscence). The subjects will have baseline and day of surgery visits performed, and then subjects will return to the investigator for evaluation of defect and safety related morbidities at follow up visits scheduled at 1 month, 6 months, 12 months, 24 months, and 36 months post-surgery.

The study will enroll up to 200 subjects at up to 20 sites. Enrollment is anticipated to take between 18 and 24 months.

Eligibility criteria: Inclusion Criteria:

Subjects who meet all of the following criteria will be eligible for study enrollment:

1. Subjects who are 18 years of age and older
2. Subjects of either sex
3. Subjects who require complex abdominal repair using Permacol™ Biological Implant.
4. 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:

1. Subjects who are pregnant
2. 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
3. Subjects may not participate in any other clinical study that clinically interferes with this study while enrolled
4. Concomitant use of a synthetic or another biologic mesh
5. Subjects who require use of Permacol™ as only temporary closure with planned reoperation, or Permacol™ used as a temporary dressing in an open abdomen
6. Subject who has systemic sepsis at the time of Permacol™ implantation
7. Subject with ongoing necrotizing pancreatitis
8. Subject who requires use of Permacol™ in parastomal hernia repair alone, where there is no other anterior wall repair
9. Subject who requires prophylactic use of Permacol™ in the formation of stoma with anterior wall repair
10. Permacol™ used in pelvic floor reconstruction

Primary outcomes:
measure: Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
timeFrame: 36 months post-surgery
Secondary outcomes:
measure: Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence
timeFrame: 24 months post-surgery
measure: QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.
timeFrame: 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.
measure: Patient Satisfaction Questionnaire - Right Choice to Have Surgery
timeFrame: 6, 12, 24 and 36 months post-surgery
measure: Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
timeFrame: 6, 12, 24 and 36 months post-surgery
measure: Number of Participants With Post-op Complications
timeFrame: 6, 12, 24 and 36 months post-surgery
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ St Lucas
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Milan
country: Italy
facility: RCCS Istituto Clinico Humanitas di Milano
city: Naples
country: Italy
facility: Istituto Nazionale Tumori
city: Rome
country: Italy
facility: University Hospital (C/O Istituto Clinica Chirugica II)
city: Esch Sur Alzette
country: Luxembourg
facility: Centre Hospitalier Emile Mayrisch
city: Leytonstone
country: United Kingdom
facility: Whipps Cross University Hospital
state: London
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: Wonford
city: Newcastle Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: Whipps Cross University Hospital
name: Pasquale Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References: