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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01268514
Recruitment Status : Active, not recruiting
First Posted : December 31, 2010
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
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

Condition or disease
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
Estimated Enrollment : 200 participants
Observational Model: Other
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
Study Start Date : February 2011
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Primary Outcome Measures :
  1. Hernia Recurrence [ Time Frame: 36 months ]
    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 :
  1. Short-term and mid-term outcomes [ Time Frame: 24 months ]
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01268514

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

Responsible Party: Medtronic - MITG Identifier: NCT01268514     History of Changes
Other Study ID Numbers: COVPERH0108
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Medtronic - MITG:
Abdominal Wall Reconstruction

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