Trial Outcomes & Findings for Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair (NCT NCT02720042)

NCT ID: NCT02720042

Last Updated: 2020-09-25

Results Overview

Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 84 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2020-09-25

Participant Flow

Study subjects were enrolled between 22-Mar-2016 and 26-Apr-2017 at 15 different sites in 8 European countries.

Participant milestones

Measure	Phasix™ Mesh Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Overall Study STARTED	84
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Phasix™ Mesh Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Overall Study Death	3
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	3
Overall Study Phasix Mesh explanted	1
Overall Study unable due to non-study-related illness	3

Baseline Characteristics

Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

Baseline characteristics by cohort

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Age, Continuous	62.5 years STANDARD_DEVIATION 12.41 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment Austria	3 participants n=5 Participants
Region of Enrollment Netherlands	14 participants n=5 Participants
Region of Enrollment Belgium	25 participants n=5 Participants
Region of Enrollment Denmark	10 participants n=5 Participants
Region of Enrollment Italy	3 participants n=5 Participants
Region of Enrollment United Kingdom	6 participants n=5 Participants
Region of Enrollment France	11 participants n=5 Participants
Region of Enrollment Germany	12 participants n=5 Participants
BMI	27.8 kg/m^2 STANDARD_DEVIATION 4.03 • n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes>

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure	22 Participants

SECONDARY outcome

Timeframe: 24 Months

Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes> "

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure	22 Participants

SECONDARY outcome

Timeframe: 24 Months

Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With a Hernia Recurrence	8 Participants

SECONDARY outcome

Timeframe: 24 Months

Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the US Centers of Disease Control and Prevention (CDC) guidelines for superficial, deep and organ/space surgical site infections.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With One or More Surgical Site Infection	12 Participants

SECONDARY outcome

Timeframe: 24 Months

Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 24-month follow up. Scores are measured on a 10.0 cm line, lower values correspond with low pain perception. The outcome measure is presented as the absolute difference between the pain perception at Baseline and the pain perception at 24-month follow up. A negative score means a decrease in pain perception.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale	-0.7 score on a scale Standard Deviation 2.45

SECONDARY outcome

Timeframe: 24 Months

Incidence Device-related Adverse Events: number of subjects with one or more possibly or definitely device-related Adverse Event.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants With One or More Device-related Adverse Event	16 Participants

SECONDARY outcome

Timeframe: 24 Months

Rate of reoperation due to the index hernia repair: the proportion of subjects with post-procedure reoperation due to the index hernia repair.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Number of Participants Requiring Reoperation Due to Index Hernia Repair	13 Participants

SECONDARY outcome

Timeframe: 24 Months

Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is the average across the domains. The Total CCS Score ranges from 0-5 and is the average of the 3 scale scores. Low scores represent fewer symptoms or difficulties.

Absolute values of the Total CCS Score at 1-Month follow-up, at 3-Month follow-up, at 12-Month follow-up and at 24-Month follow up are reported.

The absolute value at Baseline, or a change in self-reported quality of life measured by Carolinas Comfort Scale® cannot be reported, as subjects had incorrectly answered the questions on Sensation of Mesh at Baseline where no Phasix Mesh was yet implanted, thereby creating a bias in the results.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure Total CCS Score at 1-Month	0.6 score on a scale Standard Deviation 0.8
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure Total CCS Score at 3-Months	0.5 score on a scale Standard Deviation 0.84
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure Total CCS Score at 12-Months	0.3 score on a scale Standard Deviation 0.62
Mean Patient Reported Outcomes on Quality of Life Parameters as Measured by the Carolinas Comfort Scale (CCS) at 1, 3, 12 and 24 Months Post-Index Procedure Total CCS Score at 24-Months	0.3 score on a scale Standard Deviation 0.66

SECONDARY outcome

Timeframe: 24 Months

Change in self-reported quality of life measured by EuroQol-5 Dimensions (EQ-5D™). Each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) has 3 levels (no problems, some problems and extreme problems). The data is converted into a summary index number between 0 and 1, whereby 1 corresponds with the highest perception of Quality of Life. The outcome measure reports the absolute change from Baseline until 24-months follow up. A positive value corresponds with an increase in Quality of Life.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Change in Quality of Life Assessments as Measured by the EQ-5D Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure	0.11 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 1 day

Surgical procedure time as measured from incision to closure (skin to skin)

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Surgical Procedure Time of the Index Procedure as Measured From Incision to Closure	198 minutes Standard Deviation 110.86

SECONDARY outcome

Timeframe: 24 Months

Population: Of the 84 enrolled subjects, only 26 were employed at the time of the index surgery and of these 23 went back to work.

The number of days until subject returned to work, calculated as the date when employed subjects were able to fully get back to work minus the date of surgery.

Outcome measures

Measure	Phasix™ Mesh n=23 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Time Until Participants Were Able to Return to Work	101.3 days Standard Deviation 160.38

SECONDARY outcome

Timeframe: 1 Month

The length of hospital stay for the index procedure is calculated as the date of hospital discharge minus the date of hospital admission. Days in intensive care unit, days in step down unit (medium care) and days in the ward will be summarized as well.

Outcome measures

Measure	Phasix™ Mesh n=84 Participants Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Mean Length of Hospital Stay Related to Index Procedure Total Length of Hospital Stay	10.9 days Standard Deviation 7.61
Mean Length of Hospital Stay Related to Index Procedure Days in Intensive Care Unit	1.0 days Standard Deviation 3.16
Mean Length of Hospital Stay Related to Index Procedure Days in Step Down (medium care) unit	0.3 days Standard Deviation 2.18
Mean Length of Hospital Stay Related to Index Procedure Days in the Ward	9.5 days Standard Deviation 5.87

Adverse Events

Phasix™ Mesh

Serious events: 40 serious events

Other events: 35 other events

Deaths: 3 deaths

Serious adverse events

Measure	Phasix™ Mesh n=84 participants at risk Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Infections and infestations Abdominal Wall Abscess	3.6% 3/84 • Number of events 3 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Abdominal Hernia Gangrenous	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Device Related Infection	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Gastroenteritis Viral	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Medical Device Site Infection	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Pelvic Abscess	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Peritonitis	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Pneumonia	1.2% 1/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Post Procedural Pneumonia	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Postoperative Wound Infection	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Cardiac disorders Cardio-Respiratory Arrest	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Cardiac disorders Mitral Valve Incompetence	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Abdominal Fat Apron	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Haemorrhoids	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Hiatus Hernia	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Ileus	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Large Intestine Perforation	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Small Intestinal Obstruction	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Anastomotic Fistula	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Fall	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Gastrointestinal Anastomotic Leak	1.2% 1/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Hip Fracture	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Incisional Hernia	6.0% 5/84 • Number of events 5 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Incisional Hernia, Obstructive	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Postoperative Ileus	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Procedural Intestinal Perforation	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Rectal Laceration Postoperative	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Stomal Hernia	4.8% 4/84 • Number of events 4 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Subcutaneous Haematoma	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Wound Dehiscence	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Metabolism and nutrition disorders Hypokalaemia	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Musculoskeletal and connective tissue disorders Fistula	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer Recurrent	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal Cancer Recurrent	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Recurrent	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Nervous system disorders Cerebrovascular Insufficiency	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Renal and urinary disorders Acute Kidney Injury	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Renal and urinary disorders Nephrolithiasis	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Renal and urinary disorders Ureterolithiasis	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Renal and urinary disorders Urinary Retention	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Respiratory, thoracic and mediastinal disorders Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Skin and subcutaneous tissue disorders Skin Necrosis	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Iliac Artery Occlusion	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Peripheral Artery Occlusion	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Vascular disorders Peripheral Artery Thrombosis	1.2% 1/84 • Number of events 1 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.

Other adverse events

Measure	Phasix™ Mesh n=84 participants at risk Patients treated with Phasix™ Mesh for hernia repair Phasix™ Mesh: A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
Gastrointestinal disorders Abdominal Pain	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Gastrointestinal disorders Abdominal Wall Haematoma	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Incisional Hernia	4.8% 4/84 • Number of events 5 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Infections and infestations Postoperative Wound Infection	11.9% 10/84 • Number of events 11 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Seroma	17.9% 15/84 • Number of events 17 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Skin and subcutaneous tissue disorders Skin Necrosis	2.4% 2/84 • Number of events 2 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Stomal Hernia	6.0% 5/84 • Number of events 5 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Subcutaneous Haematoma	3.6% 3/84 • Number of events 3 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.
Injury, poisoning and procedural complications Wound Dehiscence	11.9% 10/84 • Number of events 10 • 24 months In this study, an Adverse Event (AE) is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region. The definition of Serious AE does not deviate. Monitors have actively reviewed the subjects' medical records for Adverse Events during monitor visits.

Additional Information

Sandra van Guldener

Becton, Dickinson and Company

Phone: +31 6 46900840

Email: sandra.vanguldener@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60