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

Completed

Conditions: Hernia, Abdominal
Abdominal Injuries

Registration Number: NCT01268514

Lead Sponsor: Medtronic - MITG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery	36 months post-surgery	Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome	6, 12, 24 and 36 months post-surgery	Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation?
QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.	6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.	Quality of Life by Carolina's Comfort Scale at 6 months, 12 months, 24 months, and 36 months. The areas of assessment were: Sensation of Mesh, Pain, and Movement Limitations at each of the follow-up time points. Unscheduled surgery is any surgery that is performed outside of the primary study procedure. The scale measurements: 0 = no symptoms; 1 = mild but not bothersome symptoms; 2 = mild and bothersome symptoms; 3 = moderate and/or daily symptoms,;4 = severe symptoms; 5 = disabling symptoms
Patient Satisfaction Questionnaire - Right Choice to Have Surgery	6, 12, 24 and 36 months post-surgery	Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery?
Number of Participants With Post-op Complications	6, 12, 24 and 36 months post-surgery	Subject incidence of post-operative complications, specifically: wound infection, seroma, hematoma, wound dehiscence, and fistula. Unscheduled surgery is any surgery that is performed outside of the primary study procedure.
Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence	24 months post-surgery	Characterize short-term and mid-term outcomes within 24 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.

Trial Locations

Locations (12): Whipps Cross University Hospital
🇬🇧
Leytonstone, London, United Kingdom
Royal Victoria Infirmary
🇬🇧
Newcastle Upon Tyne, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧
Exeter, Wonford, United Kingdom
AZ St Lucas
🇧🇪
Gent, Belgium
CHU Ambroise Paré
🇧🇪
Mons, Belgium
Istituto Nazionale Tumori
🇮🇹
Naples, Italy
University Hospital (C/O Istituto Clinica Chirugica II)
🇮🇹
Rome, Italy
CHU Ambroise Pare
🇧🇪
Mons, Belgium
Universitätsklinikum des Saarlandes
🇩🇪
Homburg, Germany
RCCS Istituto Clinico Humanitas di Milano
🇮🇹
Milan, Italy
Centre Hospitalier Emile Mayrisch
🇱🇺
Esch Sur Alzette, Luxembourg
Torbay Hospital
🇬🇧
Torquay, United Kingdom