Abdominal Injuries, Hernia, Abdominal
Conditions
Keywords
Complex, Abdominal Wall Reconstruction, AWR, Hernia
Brief 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
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.
Interventions
None listed
Sponsors
Medtronic - MITG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | 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. |
| QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 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 |
| Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 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? |
| Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 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? |
| Number of Participants With Post-op Complications | 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. |
Countries
Belgium, Germany, Italy, Luxembourg, United Kingdom
Participant flow
Recruitment details
115 patients were enrolled at 12 sites in 5 European countries.
Pre-assignment details
All subjects undergoing planned surgical treatment for complex abdominal wall repair with Permacol implantation and who agree to 36 months of follow-up. The study allowed inclusion of up to 200 subjects at up to 20 sites.
Participants by arm
| Arm | Count |
|---|---|
| Permacol Biological Implant Single Arm Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
At the Screening/Baseline (-60 days) the following patient elements are collected:
* Informed Consent
* Demographic Information
* Medical History
* Surgical History
* Concomitant Medications
* Physical Exam
* Radiographic Exam | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Death | 8 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 3 |
| Overall Study | Withdrawal by Surgeon | 5 |
Baseline characteristics
| Characteristic | Permacol Biological Implant Single Arm |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 169.0 Centimeters STANDARD_DEVIATION 10.3 |
| Region of Enrollment Belgium | 6 Participants |
| Region of Enrollment Germany | 27 Participants |
| Region of Enrollment Italy | 24 Participants |
| Region of Enrollment Luxembourg | 22 Participants |
| Region of Enrollment United Kingdom | 35 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 67 Participants |
| Subjects who require complex abdominal repair. Abdominal Wall Reconstruction | 6 Participants |
| Subjects who require complex abdominal repair. Hernia | 108 Participants |
| Weight | 88.8 Kilograms STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 115 |
| other Total, other adverse events | 41 / 115 |
| serious Total, serious adverse events | 93 / 115 |
Outcome results
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.
Time frame: 36 months post-surgery
Population: This was the number of respondents at the 36-month follow up visit for this assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Permacol Implant | Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Hernia Recurrence | Yes | 19 Participants |
| Permacol Implant | Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Hernia Recurrence | No | 66 Participants |
| Permacol Implant | Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Reoperation for Hernia | Yes | 12 Participants |
| Permacol Implant | Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery | Reoperation for Hernia | No | 73 Participants |
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.
Time frame: 6, 12, 24 and 36 months post-surgery
Population: The overall number analyzed is the total number of patients for the study. The number analyzed in each row relates to the number of patients at each visit who had one of these adverse events.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Permacol Implant | Number of Participants With Post-op Complications | All post-surgery visits | Wound infection | 16 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | All post-surgery visits | Seroma | 18 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | All post-surgery visits | Hematoma | 5 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | All post-surgery visits | Wound dehiscence | 15 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | All post-surgery visits | Fistula | 4 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | At surgery | Wound infection | 8 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | At surgery | Seroma | 3 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | At surgery | Hematoma | 2 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | At surgery | Wound dehiscence | 9 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | At surgery | Fistula | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 1-month post surgery | Wound infection | 7 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 1-month post surgery | Seroma | 10 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 1-month post surgery | Hematoma | 2 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 1-month post surgery | Wound dehiscence | 12 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 1-month post surgery | Fistula | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 6-months post surgery | Wound infection | 5 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 6-months post surgery | Seroma | 6 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 6-months post surgery | Hematoma | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 6-months post surgery | Wound dehiscence | 3 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 6-months post surgery | Fistula | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 12-months post surgery | Wound infection | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 12-months post surgery | Seroma | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 12-months post surgery | Hematoma | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 12-months post surgery | Wound dehiscence | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 12-months post surgery | Fistula | 3 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 24-months post surgery | Wound infection | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 24-months post surgery | Seroma | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 24-months post surgery | Hematoma | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 24-months post surgery | Wound dehiscence | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 24-months post surgery | Fistula | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 36-months post surgery | Wound infection | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 36-months post surgery | Seroma | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 36-months post surgery | Hematoma | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 36-months post surgery | Wound dehiscence | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | 36-months post surgery | Fistula | 0 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | Unscheduled surgeries | Wound infection | 2 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | Unscheduled surgeries | Seroma | 2 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | Unscheduled surgeries | Hematoma | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | Unscheduled surgeries | Wound dehiscence | 1 Participants |
| Permacol Implant | Number of Participants With Post-op Complications | Unscheduled surgeries | Fistula | 1 Participants |
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.
Time frame: 24 months post-surgery
Population: Proportion of subjects who underwent reoperation for hernia or hernia recurrence at 24 month post-surgery follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with primary hernia requiring reoperation | Yes | 10 Participants |
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with primary hernia requiring reoperation | No | 61 Participants |
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with primary hernia requiring reoperation | Missing | 20 Participants |
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with hernia recurrence requiring surgery | Yes | 10 Participants |
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with hernia recurrence requiring surgery | No | 61 Participants |
| Permacol Implant | Number of Participants With Short-term and Mid-term Outcomes Who Underwent Hernia Reoperation or Hernia Recurrence | Patients with hernia recurrence requiring surgery | Missing | 20 Participants |
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?
Time frame: 6, 12, 24 and 36 months post-surgery
Population: This was the number of patients included in this study assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 6-month | Very Satisfied | 46 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 6-month | Satisfied | 16 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 6-month | Somewhat Satisfied | 4 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 6-month | Not Satisfied | 0 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 12-month Visit | Very Satisfied | 45 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 12-month Visit | Satisfied | 16 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 12-month Visit | Somewhat Satisfied | 3 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 12-month Visit | Not Satisfied | 1 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 24-month Visit | Very Satisfied | 37 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 24-month Visit | Satisfied | 13 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 24-month Visit | Somewhat Satisfied | 3 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 24-month Visit | Not Satisfied | 2 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 36-month Visit | Very Satisfied | 38 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 36-month Visit | Satisfied | 8 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 36-month Visit | Somewhat Satisfied | 5 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome | 36-month Visit | Not Satisfied | 1 Participants |
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?
Time frame: 6, 12, 24 and 36 months post-surgery
Population: This is the number of patients whom were included in this study assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 6-month Visit | Yes | 58 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 6-month Visit | No | 3 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 6-month Visit | N/A | 5 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 12-month Visit | Yes | 58 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 12-month Visit | No | 1 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 12-month Visit | N/A | 6 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 24-month Visit | Yes | 46 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 24-month Visit | No | 3 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 24-month Visit | N/A | 6 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 36-month Visit | Yes | 48 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 36-month Visit | No | 1 Participants |
| Permacol Implant | Patient Satisfaction Questionnaire - Right Choice to Have Surgery | 36-month Visit | N/A | 3 Participants |
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
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.
Population: We excluded patients who were not included in this assessment at the 6 - 36 month post-surgery follow-up time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 6-month post surgery: Sensation of Mesh | 3.6 Scores on a scale | Standard Deviation 6 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 6-month post surgery: Pain | 4.2 Scores on a scale | Standard Deviation 6.9 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 6-month post surgery: Movement Limitations | 3.7 Scores on a scale | Standard Deviation 6.3 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 12-month post surgery: Sensation of Mesh | 3.11 Scores on a scale | Standard Deviation 5.1 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 12-month post surgery: Pain | 2.6 Scores on a scale | Standard Deviation 4.9 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 12-month post surgery: Movement Limitations | 1.9 Scores on a scale | Standard Deviation 4.2 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 24-month post surgery: Sensation of Mesh | 2.5 Scores on a scale | Standard Deviation 5.5 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 24-month post surgery: Pain | 2.5 Scores on a scale | Standard Deviation 7 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 24-month post surgery: Movement Limitations | 2.6 Scores on a scale | Standard Deviation 6.2 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 36-month post surgery: Sensation of Mesh | 2.6 Scores on a scale | Standard Deviation 6 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 36-month post surgery: Pain | 2.0 Scores on a scale | Standard Deviation 5.6 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | 36-month post surgery: Movement Limitations | 2.4 Scores on a scale | Standard Deviation 6 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | Unscheduled Surgery: Sensation of Mesh | 1.0 Scores on a scale | Standard Deviation 1.7 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | Unscheduled Surgery: Pain | 3.0 Scores on a scale | Standard Deviation 5.2 |
| Permacol Implant | QOL by Carolina's Comfort Scale at 6, 12, 24 and 36 Months. | Unscheduled Surgery: Movement Limitations | 3.0 Scores on a scale | Standard Deviation 5.2 |