Trial Outcomes & Findings for ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs (NCT NCT01268514)
NCT ID: NCT01268514
Last Updated: 2024-05-10
Results Overview
Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
Recruitment status
COMPLETED
Target enrollment
115 participants
Primary outcome timeframe
36 months post-surgery
Results posted on
2024-05-10
Participant Flow
115 patients were enrolled at 12 sites in 5 European countries.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
Participants Who Received the Device
|
114
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
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
ENHANCE: A Prospective EvaluatioN of Permacol™ in tHe Repair of Complex AbdomiNal Wall CasEs
Baseline characteristics by cohort
| Measure |
Permacol Biological Implant Single Arm
n=114 Participants
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
|
|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
Luxembourg
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
35 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
27 Participants
n=5 Participants
|
|
Subjects who require complex abdominal repair.
Abdominal Wall Reconstruction
|
6 Participants
n=5 Participants
|
|
Subjects who require complex abdominal repair.
Hernia
|
108 Participants
n=5 Participants
|
|
Height
|
169.0 Centimeters
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Weight
|
88.8 Kilograms
STANDARD_DEVIATION 16.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 36 months post-surgeryPopulation: This was the number of respondents at the 36-month follow up visit for this assessment.
Characterize longitudinal outcomes at 36 months post-surgery of the proportion of subjects who undergo reoperation for hernia or hernia recurrence.
Outcome measures
| Measure |
Permacol Implant
n=114 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Hernia Recurrence · Yes
|
19 Participants
|
|
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Hernia Recurrence · No
|
66 Participants
|
|
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Reoperation for Hernia · Yes
|
12 Participants
|
|
Number of Participants With Hernia Recurrence or Undergo Reoperation for Hernia at 36 Months Post-surgery
Reoperation for Hernia · No
|
73 Participants
|
SECONDARY outcome
Timeframe: 24 months post-surgeryPopulation: Proportion of subjects who underwent reoperation for hernia or hernia recurrence at 24 month post-surgery follow-up.
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.
Outcome measures
| Measure |
Permacol Implant
n=91 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Permacol Implant
n=84 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
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 6.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 7.0
|
|
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
|
|
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 6.0
|
|
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
|
|
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 6.0
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 6, 12, 24 and 36 months post-surgeryPopulation: This is the number of patients whom were included in this study assessment.
Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: Was it the right choice to have the surgery?
Outcome measures
| Measure |
Permacol Implant
n=66 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
6-month Visit · Yes
|
58 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
6-month Visit · No
|
3 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
6-month Visit · N/A
|
5 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
12-month Visit · Yes
|
58 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
12-month Visit · No
|
1 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
12-month Visit · N/A
|
6 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
24-month Visit · Yes
|
46 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
24-month Visit · No
|
3 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
24-month Visit · N/A
|
6 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
36-month Visit · Yes
|
48 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
36-month Visit · No
|
1 Participants
|
|
Patient Satisfaction Questionnaire - Right Choice to Have Surgery
36-month Visit · N/A
|
3 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 24 and 36 months post-surgeryPopulation: This was the number of patients included in this study assessment.
Patient Satisfaction Questionnaire at 6 months, 12 months, 24 months, and 36 months. Question: How satisfied are you with the outcome of the operation?
Outcome measures
| Measure |
Permacol Implant
n=66 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
6-month · Very Satisfied
|
46 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
6-month · Satisfied
|
16 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
6-month · Somewhat Satisfied
|
4 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
6-month · Not Satisfied
|
0 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
12-month Visit · Very Satisfied
|
45 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
12-month Visit · Satisfied
|
16 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
12-month Visit · Somewhat Satisfied
|
3 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
12-month Visit · Not Satisfied
|
1 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
24-month Visit · Very Satisfied
|
37 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
24-month Visit · Satisfied
|
13 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
24-month Visit · Somewhat Satisfied
|
3 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
24-month Visit · Not Satisfied
|
2 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
36-month Visit · Very Satisfied
|
38 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
36-month Visit · Satisfied
|
8 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
36-month Visit · Somewhat Satisfied
|
5 Participants
|
|
Patient Satisfaction Questionnaire - Patient Satisfaction With Operation Outcome
36-month Visit · Not Satisfied
|
1 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 24 and 36 months post-surgeryPopulation: 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.
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.
Outcome measures
| Measure |
Permacol Implant
n=115 Participants
This is the number of patients who returned for their 36 month follow-up and who were assessed for hernia recurrence.
|
|---|---|
|
Number of Participants With Post-op Complications
All post-surgery visits · Wound infection
|
16 Participants
|
|
Number of Participants With Post-op Complications
All post-surgery visits · Seroma
|
18 Participants
|
|
Number of Participants With Post-op Complications
All post-surgery visits · Hematoma
|
5 Participants
|
|
Number of Participants With Post-op Complications
All post-surgery visits · Wound dehiscence
|
15 Participants
|
|
Number of Participants With Post-op Complications
All post-surgery visits · Fistula
|
4 Participants
|
|
Number of Participants With Post-op Complications
At surgery · Wound infection
|
8 Participants
|
|
Number of Participants With Post-op Complications
At surgery · Seroma
|
3 Participants
|
|
Number of Participants With Post-op Complications
At surgery · Hematoma
|
2 Participants
|
|
Number of Participants With Post-op Complications
At surgery · Wound dehiscence
|
9 Participants
|
|
Number of Participants With Post-op Complications
At surgery · Fistula
|
1 Participants
|
|
Number of Participants With Post-op Complications
1-month post surgery · Wound infection
|
7 Participants
|
|
Number of Participants With Post-op Complications
1-month post surgery · Seroma
|
10 Participants
|
|
Number of Participants With Post-op Complications
1-month post surgery · Hematoma
|
2 Participants
|
|
Number of Participants With Post-op Complications
1-month post surgery · Wound dehiscence
|
12 Participants
|
|
Number of Participants With Post-op Complications
1-month post surgery · Fistula
|
1 Participants
|
|
Number of Participants With Post-op Complications
6-months post surgery · Wound infection
|
5 Participants
|
|
Number of Participants With Post-op Complications
6-months post surgery · Seroma
|
6 Participants
|
|
Number of Participants With Post-op Complications
6-months post surgery · Hematoma
|
1 Participants
|
|
Number of Participants With Post-op Complications
6-months post surgery · Wound dehiscence
|
3 Participants
|
|
Number of Participants With Post-op Complications
6-months post surgery · Fistula
|
1 Participants
|
|
Number of Participants With Post-op Complications
12-months post surgery · Wound infection
|
1 Participants
|
|
Number of Participants With Post-op Complications
12-months post surgery · Seroma
|
1 Participants
|
|
Number of Participants With Post-op Complications
12-months post surgery · Hematoma
|
0 Participants
|
|
Number of Participants With Post-op Complications
12-months post surgery · Wound dehiscence
|
1 Participants
|
|
Number of Participants With Post-op Complications
12-months post surgery · Fistula
|
3 Participants
|
|
Number of Participants With Post-op Complications
24-months post surgery · Wound infection
|
0 Participants
|
|
Number of Participants With Post-op Complications
24-months post surgery · Seroma
|
0 Participants
|
|
Number of Participants With Post-op Complications
24-months post surgery · Hematoma
|
0 Participants
|
|
Number of Participants With Post-op Complications
24-months post surgery · Wound dehiscence
|
0 Participants
|
|
Number of Participants With Post-op Complications
24-months post surgery · Fistula
|
0 Participants
|
|
Number of Participants With Post-op Complications
36-months post surgery · Wound infection
|
0 Participants
|
|
Number of Participants With Post-op Complications
36-months post surgery · Seroma
|
0 Participants
|
|
Number of Participants With Post-op Complications
36-months post surgery · Hematoma
|
0 Participants
|
|
Number of Participants With Post-op Complications
36-months post surgery · Wound dehiscence
|
0 Participants
|
|
Number of Participants With Post-op Complications
36-months post surgery · Fistula
|
0 Participants
|
|
Number of Participants With Post-op Complications
Unscheduled surgeries · Wound infection
|
2 Participants
|
|
Number of Participants With Post-op Complications
Unscheduled surgeries · Seroma
|
2 Participants
|
|
Number of Participants With Post-op Complications
Unscheduled surgeries · Hematoma
|
1 Participants
|
|
Number of Participants With Post-op Complications
Unscheduled surgeries · Wound dehiscence
|
1 Participants
|
|
Number of Participants With Post-op Complications
Unscheduled surgeries · Fistula
|
1 Participants
|
Adverse Events
Permacol Biological Implant Single Arm
Serious events: 93 serious events
Other events: 41 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Permacol Biological Implant Single Arm
n=115 participants at risk
Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Compartment Syndrome
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
3.5%
4/115 • Number of events 4 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
7/115 • Number of events 7 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Faecal Incontinence
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Ileus
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Intestinal Fistula
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
4.3%
5/115 • Number of events 5 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
General disorders
Chest Pain
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
General disorders
Malaise
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Immune system disorders
Allergic Granulomatous Angiitis
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Device Related Infection
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Device Related Sepsis
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Orchitis
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Postoperative Wound Infection
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Urosepsis
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Wound Infection
|
6.1%
7/115 • Number of events 7 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
4.3%
5/115 • Number of events 5 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Post Procedural Hematoma
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Post Procedural Hemorrhage
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.7%
2/115 • Number of events 2 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
7.0%
8/115 • Number of events 8 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
3/115 • Number of events 3 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm Malignant
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Lung
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Nervous system disorders
Loss of Consciousness
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Nervous system disorders
Subarachnoid Hemorrhage
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Nervous system disorders
Syncope
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Psychiatric disorders
Confusional State
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Psychiatric disorders
Substance-Induced Psychotic Disorder
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Psychiatric disorders
Renal Failure Acute
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.5%
4/115 • Number of events 4 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Surgical and medical procedures
Carotid Endarterectomy
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Surgical and medical procedures
Ileostomy
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Vascular disorders
Hematoma
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.87%
1/115 • Number of events 1 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
Other adverse events
| Measure |
Permacol Biological Implant Single Arm
n=115 participants at risk
Permacol Biological Implant was used to treat complex abdominal wall repairs (AWR) in this study. This was a single-arm study.
|
|---|---|
|
General disorders
Seroma
|
14.8%
17/115 • Number of events 18 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Recurrence of Hernia
|
5.2%
6/115 • Number of events 6 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Infections and infestations
Wound Infection
|
5.2%
6/115 • Number of events 6 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
5.2%
6/115 • Number of events 6 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.2%
6/115 • Number of events 6 • Day of surgery, and 6, 12, 24 and 36 months post-surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60