Skip to main content
OpenTrials
Completed

NCT Number: NCT01268514

ENHANCE: A Prospective EvaluatioN of Permacol™ 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hernia, Abdominal Abdominal Injuries Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ St Lucas, Ghent, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery

    Time frame: 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.

Secondary outcomes

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

    Time frame: 24 months post-surgery

    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.

  2. QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.

    Time frame: 6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.

    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

  3. Patient Satisfaction Questionnaire - Right Choice to Have Surgery

    Time frame: 6, 12, 24 and 36 months post-surgery

    Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.

    Question: Was it the right choice to have the surgery?

  4. Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome

    Time frame: 6, 12, 24 and 36 months post-surgery

    Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.

    Question: How satisfied are you with the outcome of the operation?

  5. Number of Participants With Post-op Complications

    Time frame: 6, 12, 24 and 36 months post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: ENHANCE

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2010
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.