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CompletedNCT01268514ENHANCEUpdated May 10, 2024Results posted

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

An observational study in Hernia, Abdominal and Abdominal Injuries, sponsored by Medtronic - MITG. Completed at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Medtronic - MITG (part of Medtronic) · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
115
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hernia, Abdominal
  • Abdominal Injuries

Keywords

  • Complex
  • Abdominal Wall Reconstruction
  • AWR
  • Hernia
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's enrollment of 115 is close to the median of 115 across 29 observational studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 179 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Browse Medtronic - MITG studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
115 participants (actual)
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 months post-surgery

Secondary outcomes

  1. 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.

    Time frame: 24 months post-surgery

  2. 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

    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.

  3. 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?

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

  4. 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?

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

  5. 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.

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

07

Results

Posted Feb 8, 2019

Participant flow

115 patients were enrolled at 12 sites in 5 European countries.

Participant flow — Overall Study
MilestonePermacol Biological Implant Single Arm
Started115
Participants who received the device114
Completed74
Not completed41
Withdrew: Adverse event20
Withdrew: Death8
Withdrew: Lost to follow-up5
Withdrew: Withdrawal by subject3
Withdrew: Withdrawal by surgeon5

Outcome measures

PrimaryNumber 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.

Time frame:
36 months post-surgery
Reported as:
Count of participants · Participants
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
ParticipantsPermacol Implant
Hernia Recurrence — Yes19
Hernia Recurrence — No66
Reoperation for Hernia — Yes12
Reoperation for Hernia — No73
SecondaryNumber 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.

Time frame:
24 months post-surgery
Reported as:
Count of participants · Participants
Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence
ParticipantsPermacol Biological Implant Single Arm
Patients with primary hernia requiring reoperation — Yes10
Patients with primary hernia requiring reoperation — No61
Patients with primary hernia requiring reoperation — Missing20
Patients with hernia recurrence requiring surgery — Yes10
Patients with hernia recurrence requiring surgery — No61
Patients with hernia recurrence requiring surgery — Missing20
SecondaryQOL 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

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.
Reported as:
Mean · Scores on a scale
QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months.
Scores on a scalePermacol Implant
6-month post surgery: Sensation of Mesh3.6 ± 6.0
6-month post surgery: Pain4.2 ± 6.9
6-month post surgery: Movement Limitations3.7 ± 6.3
12-month post surgery: Sensation of Mesh3.11 ± 5.1
12-month post surgery: Pain2.6 ± 4.9
12-month post surgery: Movement Limitations1.9 ± 4.2
24-month post surgery: Sensation of Mesh2.5 ± 5.5
24-month post surgery: Pain2.5 ± 7.0
24-month post surgery: Movement Limitations2.6 ± 6.2
36-month post surgery: Sensation of Mesh2.6 ± 6.0
36-month post surgery: Pain2.0 ± 5.6
36-month post surgery: Movement Limitations2.4 ± 6.0
Unscheduled Surgery: Sensation of Mesh1.0 ± 1.7
Unscheduled Surgery: Pain3.0 ± 5.2
Unscheduled Surgery: Movement Limitations3.0 ± 5.2
SecondaryPatient 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?

Time frame:
6, 12, 24 and 36 months post-surgery
Reported as:
Count of participants · Participants
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
ParticipantsPermacol Biological Implant Single Arm
6-month Visit — Yes58
6-month Visit — No3
6-month Visit — N/A5
12-month Visit — Yes58
12-month Visit — No1
12-month Visit — N/A6
24-month Visit — Yes46
24-month Visit — No3
24-month Visit — N/A6
36-month Visit — Yes48
36-month Visit — No1
36-month Visit — N/A3
SecondaryPatient 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?

Time frame:
6, 12, 24 and 36 months post-surgery
Reported as:
Count of participants · Participants
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
ParticipantsPermacol Biological Implant Single Arm
6-month — Very Satisfied46
6-month — Satisfied16
6-month — Somewhat Satisfied4
6-month — Not Satisfied0
12-month Visit — Very Satisfied45
12-month Visit — Satisfied16
12-month Visit — Somewhat Satisfied3
12-month Visit — Not Satisfied1
24-month Visit — Very Satisfied37
24-month Visit — Satisfied13
24-month Visit — Somewhat Satisfied3
24-month Visit — Not Satisfied2
36-month Visit — Very Satisfied38
36-month Visit — Satisfied8
36-month Visit — Somewhat Satisfied5
36-month Visit — Not Satisfied1
SecondaryNumber 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.

Time frame:
6, 12, 24 and 36 months post-surgery
Reported as:
Count of participants · Participants
Number of Participants With Post-op Complications
ParticipantsPermacol Implant
All post-surgery visits — Wound infection16
All post-surgery visits — Seroma18
All post-surgery visits — Hematoma5
All post-surgery visits — Wound dehiscence15
All post-surgery visits — Fistula4
At surgery — Wound infection8
At surgery — Seroma3
At surgery — Hematoma2
At surgery — Wound dehiscence9
At surgery — Fistula1
1-month post surgery — Wound infection7
1-month post surgery — Seroma10
1-month post surgery — Hematoma2
1-month post surgery — Wound dehiscence12
1-month post surgery — Fistula1
6-months post surgery — Wound infection5
6-months post surgery — Seroma6
6-months post surgery — Hematoma1
6-months post surgery — Wound dehiscence3
6-months post surgery — Fistula1
12-months post surgery — Wound infection1
12-months post surgery — Seroma1
12-months post surgery — Hematoma0
12-months post surgery — Wound dehiscence1
12-months post surgery — Fistula3
24-months post surgery — Wound infection0
24-months post surgery — Seroma0
24-months post surgery — Hematoma0
24-months post surgery — Wound dehiscence0
24-months post surgery — Fistula0
36-months post surgery — Wound infection0
36-months post surgery — Seroma0
36-months post surgery — Hematoma0
36-months post surgery — Wound dehiscence0
36-months post surgery — Fistula0
Unscheduled surgeries — Wound infection2
Unscheduled surgeries — Seroma2
Unscheduled surgeries — Hematoma1
Unscheduled surgeries — Wound dehiscence1
Unscheduled surgeries — Fistula1

Adverse events

Collected over Day of surgery, and 6, 12, 24 and 36 months post-surgery.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Permacol Biological Implant Single Arm8/115 (7%)93/115 (80.9%)41/115 (35.7%)
Most frequent serious events
Showing 10 of 60
Most frequent serious events
EventPermacol Biological Implant Single Arm
Wound DehiscenceInjury, poisoning and procedural complications8/115
Abdominal PainGastrointestinal disorders7/115
Wound InfectionInfections and infestations7/115
Intestinal ObstructionGastrointestinal disorders5/115
Incisional HerniaInjury, poisoning and procedural complications5/115
Abdominal HerniaGastrointestinal disorders4/115
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders4/115
ArthralgiaMusculoskeletal and connective tissue disorders3/115
Enterocutaneous FistulaGastrointestinal disorders2/115
IleusGastrointestinal disorders2/115
Most frequent other events
Most frequent other events
EventPermacol Biological Implant Single Arm
SeromaGeneral disorders17/115
Recurrence of HerniaInjury, poisoning and procedural complications6/115
Wound InfectionInfections and infestations6/115
Wound DehiscenceInjury, poisoning and procedural complications6/115
Abdominal PainGastrointestinal disorders6/115

Baseline characteristics

Age, Continuous
Age, Continuous(years)Permacol Biological Implant Single Arm
Mean60.8 ± 12.2
Sex: Female, Male
Sex: Female, Male(Participants)Permacol Biological Implant Single Arm
Female47
Male67
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Permacol Biological Implant Single Arm
Hispanic or Latino11
Not Hispanic or Latino103
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Permacol Biological Implant Single Arm
Belgium6
Luxembourg22
United Kingdom35
Italy24
Germany27
Subjects who require complex abdominal repair.
Subjects who require complex abdominal repair.(Participants)Permacol Biological Implant Single Arm
Abdominal Wall Reconstruction6
Hernia108
Height
Height(Centimeters)Permacol Biological Implant Single Arm
Mean169.0 ± 10.3
Weight
Weight(Kilograms)Permacol Biological Implant Single Arm
Mean88.8 ± 16.6
08

Study locations

12 sites
  • AZ St Lucas
    Gent, Belgium
  • CHU Ambroise Pare
    Mons, 7000, Belgium
  • CHU Ambroise Paré
    Mons, Belgium
  • Universitätsklinikum des Saarlandes
    Homburg, 66424, Germany
  • 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, 4005, Luxembourg
  • Whipps Cross University Hospital
    Leytonstone, London E11 1NR, United Kingdom
  • Royal Devon and Exeter Hospital
    Exeter, Wonford EX2 5DW, United Kingdom
  • Royal Victoria Infirmary
    Newcastle Upon Tyne, NE1 4LP, United Kingdom
  • Torbay Hospital
    Torquay, TQ2 7AA, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01268514
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Dec 31, 2010
Start date
Feb 2011
Primary completion
Nov 2016
Completion
Nov 2016
Results posted
Feb 8, 2019
Last update
May 10, 2024

Study contacts

Pasquale Giordano, MD
principal investigator · Whipps Cross University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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