A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

• Sponsor: C. R. Bard (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01961687
• Collaborator: FGK Clinical Research GmbH (Industry)
• Enrollment: 121
• Locations: 16
• Arm: 1
• Actual Duration (Months): 76.8
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

Condition or Disease	Intervention/Treatment	Phase
Ventral Hernia; Incisional Hernia	Device: Resorbable Mesh	N/A

Detailed Description

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
• Actual Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jan 27, 2020
• Actual Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Resorbable Mesh Phasix Mesh	Device: Resorbable Mesh; Phasix Mesh

Outcome Measures

Primary Outcome Measures

1. Hernia Recurrence Rate [60 Months]

   Hernia recurrence rates will be assessed by physical examination at each study visit through 60 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. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.

2. Surgical Site Infections [60 Months]

   Infections at the surgical site will be assessed by physical examination at each study visit through 60 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 CDC guidelines for superficial and deep surgical site infections

Secondary Outcome Measures

1. Pain Visual Analog Scale [60 Months]

   Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.

2. Device Related Adverse Events [60 Months]

   Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events.

3. Rate of Re-operation Due to the Index Hernia Repair [60 Months]

   Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.

4. Carolinas Comfort Scale® (CCS) [60 Months]

   Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 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 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-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.

5. SF-12 Questionnaire [60 Months]

   The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

6. Surgical Procedure Time as Measured From Incision to Closure [1 day]

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

7. Length of Hospital Stay [35 days]

   Time in days from hospital admission to discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must have met all of the criteria listed below to be enrolled in the study:

1. Subject must have been 18 years of age or older 2. Subject or subject's legally authorized representative must have given written informed consent 3. Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4) 3. Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0) 4. Subject must have had a hernia greater than 10 cm2 and ≤350 cm2 5. Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4) 5. Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0) 6. Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol) 7.

Subjects must have had 1 or more of the following pre-study conditions:

1. Body Mass Index (BMI) between 30-40 kg/m2, inclusive

2. Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)

3. COPD presence on patient self-report

4. Diabetes mellitus

5. Immunosuppression

6. Coronary Artery Disease

7. Chronic corticosteroid use: greater than 6 months systemic use

8. Serum albumin less than 3.4 g/dL

9. Advanced age: 75 years or older

10. Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL

Exclusion Criteria:

Subjects were excluded from study enrollment if any of the following criteria were met:

1. Subject's hernia had recurred more than once (protocol version 1.4)

2. Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)

3. The subject had peritonitis

4. The subject was on or suspected to be placed on chemotherapy medications during any part of the study

5. The subject's Body Mass Index (BMI) was greater than 40 kg/m2

6. The subject had cirrhosis of the liver and/or ascites

7. Subject was American Society of Anesthesiology Class 4 or 5

8. Subject was known to be infected with human immunodeficiency virus (HIV)

9. Subject had a life expectancy of less than 2 years at the time of enrollment

10. Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements

11. Subject's hernia repair utilized intraabdominal mesh placement

12. Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol)

13. Subject had an active or latent systemic infection

14. Subject required surgical bridge repair as the sole repair

15. Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding

16. Subject had enrolled in another clinical study within the last 30 days

17. Subject was part of the site personnel directly involved with this study

18. Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92103
2	Florida Hospital/Celebration Health	Celebration	Florida	United States	34747
3	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
4	Indiana University	Indianapolis	Indiana	United States	46202
5	University of Kentucky Medical Center	Lexington	Kentucky	United States	40506
6	Baystate Medical Center	Springfield	Massachusetts	United States	01199
7	University of Massachusetts Worcester	Worcester	Massachusetts	United States	01655
8	Methodist Health System	Omaha	Nebraska	United States	68114
9	Southeast Area Health and Education Center	Wilmington	North Carolina	United States	28403
10	Oregon Health and Science University	Portland	Oregon	United States	97239
11	Univerity of Tennessee Health Science Center	Germantown	Tennessee	United States	38163
12	University of Tennessee Health Sciences Center	Knoxville	Tennessee	United States	37996
13	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
14	Virginia Commonwealth University	Richmond	Virginia	United States	23219
15	University of Wisconsin System	Madison	Wisconsin	United States	53792
16	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• C. R. Bard
• FGK Clinical Research GmbH

Investigators

• Principal Investigator: Scott Roth, MD, University of Kentucky

Study Documents (Full-Text)

• Study Protocol - Oct 30, 2017
• Statistical Analysis Plan - Aug 7, 2018

More Information

Publications

None provided.

• Responsible Party: C. R. Bard
• ClinicalTrials.gov Identifier: NCT01961687
• Other Study ID Numbers: DVL-HE-011
• First Posted: Oct 11, 2013
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hernia; Hernia, Ventral; Incisional Hernia

Study Results

Participant Flow

Arm/Group Title	Phasix Mesh Group
Arm/Group Description	Patients requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Period Title: Overall Study
STARTED	121
COMPLETED	60
NOT COMPLETED	61

Baseline Characteristics

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Overall Participants	121
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	94 77.7%
>=65 years	27 22.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.7 (12.0)
Sex: Female, Male (Count of Participants)
Female	46 38%
Male	75 62%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 6.6%
Not Hispanic or Latino	113 93.4%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 4.1%
White	116 95.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	121 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.24 (4.52)

Outcome Measures

1. Primary Outcome

Title	Hernia Recurrence Rate
Description	Hernia recurrence rates will be assessed by physical examination at each study visit through 60 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. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Count of Participants [Participants]	20 16.5%

2. Primary Outcome

Title	Surgical Site Infections
Description	Infections at the surgical site will be assessed by physical examination at each study visit through 60 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 CDC guidelines for superficial and deep surgical site infections
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Count of Participants [Participants]	11 9.1%

3. Secondary Outcome

Title	Pain Visual Analog Scale
Description	Mean change in self-reported pain measured on a Visual Analog Scale between Baseline and 60-month follow up. Scores are measured on a scale from 0.0 to 10.0 centimeters and marked on a line by the subject; lower values correspond with low pain perception. The outcome measure is presented as the mean of the absolute difference between the pain perception at Baseline and the pain perception at 60-month follow up. A negative score means a decrease in pain perception.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Mean (Standard Deviation) [cm]	-3.16 (3.35)

4. Secondary Outcome

Title	Device Related Adverse Events
Description	Incidence of device related adverse events: number of subjects with one or more possibly or definitely device related adverse events. The term "incidence" is an error and is reported here as the rate of device related adverse events.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Count of Participants [Participants]	19 15.7%

5. Secondary Outcome

Title	Rate of Re-operation Due to the Index Hernia Repair
Description	Rate of re-operation due to the index hernia repair; the proportion of subjects with post-procedure re-operation due do the index hernia repair.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Count of Participants [Participants]	18 14.9%

6. Secondary Outcome

Title	Carolinas Comfort Scale® (CCS)
Description	Each scale score (sensation of mesh, pain or movement limitations) ranges from 0-5 and is a summation of scores across the domains. Therefore, the Total CCS Score ranges from 0-115 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 6-Month follow-up, 12-Month follow-up, 18-Month follow up, at 24-Month follow-up, 36-Month follow-up, 48-Month follow-up, and 60-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.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

The number of participants noted at each time point differ from the overall number (121) due to only having the eligible questionnaires being analyzed. The number of eligible questionnaires range from 52 to 111.

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Total CCS Score at 1 Month	31.2 (23.3)
Total CCS Score at 3 Month	18.5 (20.9)
Total CCS Score at 6 Month	14.1 (20.7)
Total CCS Score at 12 Month	11.6 (21.1)
Total CCS Score at 18 Month	8.4 (16.6)
Total CCS Score at 24 Month	10.5 (20.7)
Total CCS Score at 36 Month	9.8 (21.4)
Total CCS Score at 48 Month	9.8 (21.4)
Total CCS Score at 60 Month	4.9 (14.2)

7. Secondary Outcome

Title	SF-12 Questionnaire
Description	The Short Form (SF)-12 version 2 (v2) is a multi-purpose, twelve item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health and social functioning. The SF-12v2 yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time Frame	60 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
PCS - Month 1	-2.700 (9.999)
PCS - Month 3	5.374 (8.951)
PCS - Month 6	6.943 (9.352)
PCS - Month 12	6.868 (10.986)
PCS - Month 18	7.589 (11.416)
PCS - Month 24	6.206 (10.442)
PCS - Month 36	7.101 (9.652)
PCS - Month 48	7.206 (12.045)
PCS - Month 60	7.374 (9.997)
MCS - Month 1	0.546 (10.304)
MCS - Month 3	3.287 (9.822)
MCS - Month 6	3.311 (9.911)
MCS - Month 12	2.124 (9.648)
MCS - Month 18	2.015 (11.183)
MCS - Month 24	2.769 (9.841)
MCS - Month 36	-0.239 (11.142)
MCS - Month 48	2.393 (10.240)
MCS - Month 60	3.248 (10.782)

8. Secondary Outcome

Title	Surgical Procedure Time as Measured From Incision to Closure
Description	Surgical procedure time as measured from incision to closure (skin to skin)
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Mean (Full Range) [Minutes]	168

9. Secondary Outcome

Title	Length of Hospital Stay
Description	Time in days from hospital admission to discharge
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
Measure Participants	121
Median (Full Range) [Days]	4

Adverse Events

Time Frame	60 Months
Adverse Event Reporting Description	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.
Arm/Group Title	Phasix Mesh
Arm/Group Description	Subjects requiring primary ventral, incisional, or recurrent hernia repair at high risk for complications. Subjects defined to be at high risk must have one or more of the following conditions pre-study: body mass index (BMI) between 30-40 kg/m2 inclusive, be an active smoker, have chronic obstructive pulmonary disease (COPD), diabetes mellitus, immunosuppression, coronary artery disease, chronic corticosteroid use (>6 months systemic use), serum albumin ≤3.4 g/dL, age over 75 years, or renal insufficiency (defined as serum creatinine concentration ≥2.5 mg/dL).
All Cause Mortality
	Phasix Mesh
	Affected / at Risk (%)	# Events
Total	7/121 (5.8%)
Serious Adverse Events
	Phasix Mesh
	Affected / at Risk (%)	# Events
Total	49/121 (40.5%)
Cardiac disorders
Cardiac Arrest	2/121 (1.7%)	2
Cardiac Failure Acute	1/121 (0.8%)	1
Cardio-respiratory Arrest	1/121 (0.8%)	1
Right Ventricular Failure	1/121 (0.8%)	1
Gastrointestinal disorders
Abdominal Adhesions	1/121 (0.8%)	1
Abdominal Distension	1/121 (0.8%)	1
Abdominal Pain	2/121 (1.7%)	2
Abdominal Wall Disorder	1/121 (0.8%)	1
Colitis	1/121 (0.8%)	1
Colonic Pseudo-obstruction	1/121 (0.8%)	1
Food Poisoning	1/121 (0.8%)	1
Gastrointestinal Haemorrhage	2/121 (1.7%)	2
Gastroesophageal Reflux Disease	1/121 (0.8%)	1
Hiatus Hernia	1/121 (0.8%)	1
Ileus	1/121 (0.8%)	1
Inguinal Hernia	2/121 (1.7%)	2
Intestinal Obstruction	1/121 (0.8%)	1
Peptic Ulcer Haemorrhage	1/121 (0.8%)	1
Small Intestinal Obstruction	5/121 (4.1%)	8
Upper Gastrointestinal Haemorrhage	1/121 (0.8%)	1
General disorders
Death	2/121 (1.7%)	2
Generalized Oedema	1/121 (0.8%)	1
Pyrexia	1/121 (0.8%)	1
Hepatobiliary disorders
Cholecystitis Chronic	1/121 (0.8%)	1
Cholelithiasis	1/121 (0.8%)	1
Hepatic Failure	1/121 (0.8%)	1
Infections and infestations
Abdominal Abscess	1/121 (0.8%)	2
Clostidium Deficile Infection	1/121 (0.8%)	1
Pneumonia	2/121 (1.7%)	2
Post-operative Wound Infection	5/121 (4.1%)	5
Sepsis	2/121 (1.7%)	2
Septic Shock	2/121 (1.7%)	2
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence	2/121 (1.7%)	2
Cardiac Valve Replacement Complication	2/121 (1.7%)	2
Fall	1/121 (0.8%)	1
Hip Fracture	1/121 (0.8%)	1
Incision Site Erythema	1/121 (0.8%)	1
Incision Site Haematoma	1/121 (0.8%)	1
Incisional Hernia	12/121 (9.9%)	12
Incisional Hernia, Obstructive	1/121 (0.8%)	1
Joint Dislocation	1/121 (0.8%)	1
Overdose	1/121 (0.8%)	1
Post Procedural Haematoma	1/121 (0.8%)	1
Postoperative Wound Complication	2/121 (1.7%)	2
Procedural Pain	1/121 (0.8%)	1
Seroma	2/121 (1.7%)	2
Skin Flap Necrosis	1/121 (0.8%)	1
Ureteric Injury	1/121 (0.8%)	1
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration	1/121 (0.8%)	1
Muscle Necrosis	1/121 (0.8%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer	1/121 (0.8%)	1
Colon Cancer	1/121 (0.8%)	1
Pseudomyxoma Peritonei	1/121 (0.8%)	1
Nervous system disorders
Embolic Cerebral Infarction	1/121 (0.8%)	1
Encephalopathy	2/121 (1.7%)	3
Hemiparesis	1/121 (0.8%)	1
Hemiplegia	1/121 (0.8%)	1
Metabolic encephalopathy	1/121 (0.8%)	1
Neuralgia	1/121 (0.8%)	1
Serotonin Syndrome	1/121 (0.8%)	1
Transient Ischaemic Attack	1/121 (0.8%)	1
Renal and urinary disorders
Renal Failure Acute	2/121 (1.7%)	2
Reproductive system and breast disorders
Adnexa Uteri Cyst	1/121 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	2/121 (1.7%)	3
Atelectasis	1/121 (0.8%)	1
Chronic Obstructive Pulmonary Disease	1/121 (0.8%)	1
Pulmonary Embolism	3/121 (2.5%)	3
Respiratory Failure	3/121 (2.5%)	3
Restrictive Pulmonary Disease	1/121 (0.8%)	1
Skin and subcutaneous tissue disorders
Skin Necrosis	1/121 (0.8%)	1
Vascular disorders
Aortic Aneurysm	2/121 (1.7%)	3
Deep Vein Thrombosis	1/121 (0.8%)	1
Hypertension	1/121 (0.8%)	1
Intra-abdominal Haematoma	1/121 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Phasix Mesh
	Affected / at Risk (%)	# Events
Total	104/121 (86%)
Gastrointestinal disorders
Abdominal Pain	26/121 (21.5%)	30
Constipation	7/121 (5.8%)	8
Diarrhoea	7/121 (5.8%)	7
Ileus	8/121 (6.6%)	8
Nausea	14/121 (11.6%)	15
Vomiting	7/121 (5.8%)	8
Infections and infestations
Postoperative Wound Infection	6/121 (5%)	6
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence	19/121 (15.7%)	20
Incisional Hernia	11/121 (9.1%)	12
Procedural Pain	14/121 (11.6%)	14
Seroma	11/121 (9.1%)	13
Renal and urinary disorders
Urinary Retention	6/121 (5%)	7

Limitations/Caveats

The study was designed as a single arm observational trial without pre-defined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment or conclusions can be made.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.