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

NCT01268514 | Completed Results

• 1 other identifier: COVPERH0108
• Study Type: observational
• Target: 115
• Locations: 5 countries
• Sites: 12

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

Conditions

Hernia, Abdominal; Abdominal Injuries

Keywords

Complex; Abdominal Wall Reconstruction; AWR; Hernia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence

  24 months post-surgery

• 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.

• Patient Satisfaction Questionnaire - Right Choice to Have Surgery

  6, 12, 24 and 36 months post-surgery

• Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome

  6, 12, 24 and 36 months post-surgery

• Number of Participants With Post-op Complications

  6, 12, 24 and 36 months post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (12)

AZ St Lucas

Ghent, Belgium

Location

CHU Ambroise Pare

Mons, 7000, Belgium

Location

CHU Ambroise Paré

Mons, Belgium

Location

Universitätsklinikum des Saarlandes

Homburg, 66424, Germany

Location

RCCS Istituto Clinico Humanitas di Milano

Milan, Italy

Location

Istituto Nazionale Tumori

Naples, Italy

Location

University Hospital (C/O Istituto Clinica Chirugica II)

Rome, Italy

Location

Centre Hospitalier Emile Mayrisch

Esch-sur-Alzette, 4005, Luxembourg

Location

Whipps Cross University Hospital

Leytonstone, London, E11 1NR, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, Wonford, EX2 5DW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Torbay Hospital

Torquay, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Hernia, Abdominal; Abdominal Injuries; Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Andrea DiScipio, Clinical Research Associate
• Organization: Medtronic

andrea.l.discipio@medtronic.com

781-491-5350

Study Officials

• Pasquale Giordano, MD

  Whipps Cross University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 10, 2024
• Results First Posted: February 8, 2019

Record last verified: 2024-05

Locations

BE (3); LU (1); IT (3); GB (4); DE (1)