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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01268514
Other study ID # COVPERH0108
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2011
Est. completion date November 2016

Study information

Verified date May 2024
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Belgium AZ St Lucas Gent
Belgium CHU Ambroise Pare Mons
Belgium CHU Ambroise Paré Mons
Germany Universitätsklinikum des Saarlandes Homburg
Italy RCCS Istituto Clinico Humanitas di Milano Milan
Italy Istituto Nazionale Tumori Naples
Italy University Hospital (C/O Istituto Clinica Chirugica II) Rome
Luxembourg Centre Hospitalier Emile Mayrisch Esch Sur Alzette
United Kingdom Royal Devon and Exeter Hospital Exeter Wonford
United Kingdom Whipps Cross University Hospital Leytonstone London
United Kingdom Royal Victoria Infirmary Newcastle Upon Tyne
United Kingdom Torbay Hospital Torquay

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Luxembourg,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence 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. 24 months post-surgery
Secondary QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. 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
6, 12, 24 and 36 months post-surgery. We excluded patients who were not included in this assessment at the various time-points.
Secondary Patient Satisfaction Questionnaire - Right Choice to Have Surgery Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.
Question: Was it the right choice to have the surgery?
6, 12, 24 and 36 months post-surgery
Secondary Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months.
Question: How satisfied are you with the outcome of the operation?
6, 12, 24 and 36 months post-surgery
Secondary Number of Participants With Post-op Complications 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. 6, 12, 24 and 36 months post-surgery
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