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

ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs

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

Study Overview

• Status: Completed
• Conditions: Hernia, Abdominal; Abdominal Injuries

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.

• Study Type: Observational
• Enrollment (Actual): 115

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium
    • AZ St Lucas
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
  • Mons, Belgium
    • CHU Ambroise Pare
• Germany
  • Homburg, Germany, 66424
    • Universitätsklinikum des Saarlandes
• Italy
  • Milan, Italy
    • RCCS Istituto Clinico Humanitas di Milano
  • Naples, Italy
    • Istituto Nazionale Tumori
  • Rome, Italy
    • University Hospital (C/O Istituto Clinica Chirugica II)
• Luxembourg
  • Esch Sur Alzette, Luxembourg, 4005
    • Centre Hospitalier Emile Mayrisch
• United Kingdom
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay Hospital
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Whipps Cross University Hospital
  • Wonford
    • Exeter, Wonford, United Kingdom, EX2 5DW
      • Royal Devon and Exeter Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 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.	36 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence	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.	24 months post-surgery
QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.	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	6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.
Patient Satisfaction Questionnaire - Right Choice to Have Surgery	Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery?	6, 12, 24 and 36 months post-surgery
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome	Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation?	6, 12, 24 and 36 months post-surgery
Number of Participants With Post-op Complications	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.	6, 12, 24 and 36 months post-surgery

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Pasquale Giordano, MD, Whipps Cross University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimated): December 31, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Complex; Hernia; Abdominal Wall Reconstruction; AWR
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathological Conditions, Anatomical; Hernia; Hernia, Abdominal; Internal Hernia; Abdominal Injuries
• Other Study ID Numbers: COVPERH0108