We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01268514
First Posted: December 31, 2010
Last Update Posted: November 16, 2017
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.
Information provided by (Responsible Party):
Medtronic - MITG
December 29, 2010
December 31, 2010
November 16, 2017
February 2011
March 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01268514 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
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

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.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
All subjects who will undergo planned surgical treatment for complex abdominal wall repair with Permacol™ implantation and agree to 36 months of follow-up.
  • Hernia, Abdominal
  • Abdominal Injuries
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 2017
March 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy,   Luxembourg,   United Kingdom
 
 
NCT01268514
COVPERH0108
No
Not Provided
Not Provided
Medtronic - MITG
Medtronic - MITG
Not Provided
Principal Investigator: Pasquale Giordano, MD Whipps Cross University Hospital
Medtronic - MITG
February 2017