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

Hernia, Abdominal Clinical Trial

— ENHANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268514
• Other study ID #: COVPERH0108
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Injuries
• Hernia
• Hernia, Abdominal
• Internal Hernia

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