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

This study is currently recruiting participants.
Verified October 2013 by Covidien
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01268514
First received: December 29, 2010
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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


Condition
Hernia, Abdominal
Abdominal Injuries

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: ENHANCE: A Prospective Long-term EvaluatioN of the Use of Permacol™ Biological Implant in tHe Repair of Complex AbdomiNal Wall CasEs

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Hernia Recurrence [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    o Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.


Secondary Outcome Measures:
  • Short-term and mid-term outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    • 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.
    • QOL by Carolinas Comfort Scale
    • Patient Satisfaction Questionnaire
    • Subjects incidence of post-operative complications


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268514

Contacts
Contact: Jessica Carlson 203 821 4734 jessica.carlson@covidien.com
Contact: Megan Soares megan.soares@covidien.com

Locations
Belgium
AZ St.-Jan AV Recruiting
Brugge, Belgium
Contact: Tom Feryn, MD    +32 50452560      
Principal Investigator: Feryn, MD         
AZ St Lucas Recruiting
Gent, Belgium
Contact: Oliver Van Kerschaver, MD    +003292246224      
Principal Investigator: Dr. Van Kerschaver, MD         
CHU Ambroise Paré Recruiting
Mons, Belgium
Contact: Jean Lemaitre, MD    +32 65 392514      
Principal Investigator: Dr. Lemaitre, MD         
Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66424
Contact: Jochen Schuld, MD    +49 6841 163 1009      
Principal Investigator: Jochen Schuld, MD         
Italy
RCCS Istituto Clinico Humanitas di Milano Recruiting
Milan, Italy
Contact: Montorsi Montorsi, MD    +39 282244071      
Principal Investigator: Marco Montorsi, MD         
Istituto Nazionale Tumori Recruiting
Naples, Italy
Contact: Paolo Delrio, MD    +39 0815903310      
Principal Investigator: Paolo Delrio, MD         
University Hospital (C/O Istituto Clinica Chirugica II) Recruiting
Rome, Italy
Contact: Francesco Gossetti, MD    +0039 3388311941      
Principal Investigator: Francesco Gossetti, MD         
Luxembourg
Centre Hospitalier Emile Mayrisch Recruiting
Esch Sur Alzette, Luxembourg, 4005
Contact: Nikolaus Zuegel, Prof    +352541053      
Principal Investigator: Nikolaus Zuegel, MD         
United Kingdom
Whipps Cross University Hospital Recruiting
Leytonstone, London, United Kingdom, E11 1NR
Contact: Pasquale Giordano    +0044(0)20 8535 6656      
Principal Investigator: Pasquale Giordano, MD         
Royal Devon and Exeter Hospital Recruiting
Exeter, Wonford, United Kingdom, EX2 5DW
Contact: Ian Daniels    +01392 402 703      
Principal Investigator: Ian Daniels, MD         
Royal Victoria Infirmary Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Contact: Ben Griffiths    +44 7725478511      
Principal Investigator: Ben Griffiths, MD         
Torbay Hospital Recruiting
Torquay, United Kingdom, TQ2 7AA
Contact: Rupert Pullan    +01 803 654982      
Principal Investigator: Rupert Pullan, MD         
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Pasquale Giordano, MD Whipps Cross University Hospital
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01268514     History of Changes
Other Study ID Numbers: COVPERH0108
Study First Received: December 29, 2010
Last Updated: October 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Ethics Committee
Germany: Ethics Commission
Luxembourg: Comite National d'Ethique de Recherche
Italy: Ethics Committee

Keywords provided by Covidien:
Complex
Abdominal Wall Reconstruction
AWR
Hernia

Additional relevant MeSH terms:
Hernia
Hernia, Abdominal
Abdominal Injuries
Wounds and Injuries
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014