A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
Phase: NA
Conditions: Ventral Hernia, Incisional Hernia
Sponsor: C. R. Bard

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CLINICAL STUDY PROTOCOL 
 
 
Title:                            
A Prospective, Multi-Center Study of Phasix™ Mesh for 
Ventral or Incisional Hernia Repair. 
 
Protocol Number:   
DVL-HE-011 
 
Study Type: 
Post-market, multi-center, prospective, open label 
 
Date: 
October 30, 2017 
 
Version: 
4.0 
 
Study Devices: 
Phasix™ Mesh 
 
Sponsor: 
Davol Inc. 
 
Subsidiary of C. R. Bard, Inc. 
 
100 Crossings Boulevard 
 
Warwick, RI 02886 
 
Phone:  1-800-556-6756 
 
Sponsor Contacts: 
Rushil Sankpal  
Project Manager, Corporate Clinical Affairs 
C. R. Bard, Inc.  
730 Central Avenue 
Murray Hill, NJ  07974 
Telephone:  908-277-8082 
Email:  Rushil.sankpal@crbard.com 
 
 
 
 
 
 
 
 
 

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Protocol Signature Page 
 
The Investigator agrees to conduct the clinical study, which is the subject of this protocol, in 
accordance with the Clinical Study Agreement, this protocol, all applicable laws and 
regulations, and the conditions of approval imposed by the reviewing Institutional Review 
Board. 
 
 
Agreed to by (Investigator):  
 
_______________________________________________ 
Printed Name – Investigator   
 
 
 
 
 
 
 
 
 
 
 
_______________________________________________ 
Signature – Investigator  
 
 
 
 
 
 
 
 
_______________________________________________ 
Date 
 
 
 
 

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Protocol Abbreviations/Acronyms 
 
Abbreviation/Acronym 
Definition 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BMI 
Body Mass Index 
CDC 
US Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
Cm 
Centimeter 
CT 
Computed Tomography Scan 
COPD 
Chronic Obstructive Pulmonary Disease 
CST 
Component Separation Technique 
CV 
Curriculum vitae 
eCRF 
Electronic Case Report Form 
e.g. 
For Example 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
Hrs 
Hours 
ICF 
Informed Consent Form 
i.e. 
That Is 
IRB 
Institutional Review Board 
IFU 
Instructions For Use 
LTF 
Lost to Follow-Up 
Mm 
Millimeter 
MRI 
Magnetic Resonance Imaging 
N 
Sample Size 
P4HB 
poly-4-hydroxybutyrate 
PE 
Physical Exam 
SAE 
Serious Adverse Event 
SF-12® 
12-Item Short Form 
SSI 
Surgical Site Infection 
VAC 
Vacuum Assisted Closure system 
VAS 
Visual Analogue Scale 
 

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TABLE OF CONTENTS 
 
1 
INTRODUCTION .................................................................................................. 7 
1.1 
Background ............................................................................................................. 7 
1.2 
Rationale .................................................................................................................. 9 
1.3 
Device Descriptions ................................................................................................. 9 
1.3.1 
Phasix™ Mesh ...................................................................................................... 9 
2 
STUDY OBJECTIVES........................................................................................... 9 
3 
STUDY ENDPOINTS ............................................................................................. 9 
4 
STUDY DESIGN ................................................................................................... 10 
5 
STUDY POPULATION ....................................................................................... 11 
5.1 
Number Of Subjects ............................................................................................. 11 
5.2 
Eligibility Criteria – Enrollment Period ............................................................. 11 
5.2.1 
Inclusion Criteria ................................................................................................ 11 
5.2.2 
Exclusion Criteria ............................................................................................... 11 
5.3 
Eligibility Criteria – Extension ............................................................................ 12 
5.3.1 
Inclusion Criteria ................................................................................................ 12 
5.3.2 
Exclusion Criteria ............................................................................................... 12 
6 
STUDY PROCEDURES ...................................................................................... 12 
6.1 
Subject Screening and Baseline Evaluation ....................................................... 12 
6.1.1 
Informed Consent................................................................................................ 13 
6.1.2 
Enrollment........................................................................................................... 13 
6.1.3 
Eligibility ............................................................................................................ 13 
6.1.4 
Assignment of Subject Screening Number ......................................................... 14 
6.1.5 
Blinding............................................................................................................... 14 
6.1.6 
Demographics and Medical History ................................................................... 14 
6.1.7 
Physical Examination.......................................................................................... 14 
6.1.8 
Concomitant Pain Medication Usage.................................................................. 14 
6.1.9 
Patient Reported Outcome Assessments ............................................................. 14 
6.2 
Surgical Procedure ............................................................................................... 14 
6.2.1 
General Procedures ............................................................................................. 14 
6.2.2 
Component Separation Technique Surgery ........................................................ 15 

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6.2.2.1 
Open Technique .......................................................................................... 15 
6.2.2.2 
Posterior Technique .................................................................................... 16 
6.2.2.3 
Endoscopic/Minimally Invasive Technique ............................................... 16 
6.2.2.4 
Open or Endoscopic Technique .................................................................. 16 
6.2.3 
Postoperative Care .............................................................................................. 17 
6.2.4 
Surgical Details ................................................................................................... 17 
6.3 
Subject Follow-up ................................................................................................. 17 
6.3.1 
Subjects Not Implanted and Surgical Repair Failures ........................................ 18 
6.3.2 
Subjects Successfully Implanted ......................................................................... 18 
6.3.3 
Assessments ........................................................................................................ 19 
6.3.3.1 
Roll in Visit ................................................................................................. 19 
6.3.3.2 
30 Month Follow Up (910 days ± 30 days), 42 Month Follow Up (1275 ± 
30 days), 54 Month Follow Up (1640 days ± 30 days) .............................................. 19 
6.3.4 
Unscheduled Visits ............................................................................................. 20 
6.4 
TABLE OF STUDY EVENTS ............................................................................. 21 
6.4 
TABLE OF STUDY EVENTS (cont.) ................................................................. 22 
6.5 
Withdrawal and/or Early Termination .............................................................. 23 
7 
STATISTICAL METHODS ................................................................................ 23 
7.1 
Study Hypothesis................................................................................................... 23 
7.2 
Sample Size Considerations ................................................................................. 24 
7.3 
Data Analysis ......................................................................................................... 24 
8 
ADVERSE EVENTS ............................................................................................ 24 
8.1 
Definition Of Adverse Events .............................................................................. 25 
8.2 
Definition of Serious Adverse Events .................................................................. 25 
8.3 
Relationship of Adverse Event to Device/Procedure ......................................... 25 
8.4 
Severity Of Adverse Events ................................................................................. 26 
8.5 
Reporting Of Adverse Events .............................................................................. 26 
9 
MECHANICAL FAILURES, MALFUNCTIONS AND DEFECTS ............... 27 
10 
CASE REPORT FORMS ..................................................................................... 27 
11 
RISK/BENEFIT ANALYSIS ............................................................................... 27 
12 
ADMINISTRATIVE REQUIREMENTS ........................................................... 28 
12.1 
Publication Policy ................................................................................................. 28 

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12.2 
Investigator Selection ........................................................................................... 28 
12.3 
Regulatory and Ethical Considerations .............................................................. 28 
12.3.1 
Institutional Review Board Approval ............................................................. 29 
12.3.2 
Informed Consent and HIPAA Authorization ................................................ 29 
12.3.3 
Confidentiality ................................................................................................ 29 
12.4 
Protocol Adherence and Deviations .................................................................... 29 
12.5 
Device Accountability ........................................................................................... 30 
12.6 
Data Collection ...................................................................................................... 30 
12.7 
Subject Compensation .......................................................................................... 30 
12.8 
Communications with the Sponsor ..................................................................... 30 
12.9 
Required Documentation ..................................................................................... 30 
13 
SITE MONITORING ........................................................................................... 31 
13.1 
Study Initiation Visit ............................................................................................ 31 
13.2 
Ongoing Monitoring Visits ................................................................................... 33 
13.3 
Final Monitoring Visit .......................................................................................... 33 
14 
TERMINATION OF STUDY .............................................................................. 33 
15 
REPORTING REQUIREMENTS ...................................................................... 33 
16 
RECORD RETENTION ...................................................................................... 34 
17 
REFERENCES ...................................................................................................... 35 
18 
APPENDICES ....................................................................................................... 38 
 
 

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1 
INTRODUCTION 
 
1.1 
Background 
 
With more than 2 million abdominal operations occurring annually in the United States (US), 
up to 20% of those patients developing ventral incisional hernias, abdominal wall defects and 
incisional hernias represent a challenging surgical condition.1, 2 Approximately 250,000 
ventral hernia repairs are performed on a yearly basis.3 There are several options for repair, 
including primary repair, synthetic or biologic material placement, repair with relaxing 
incisions, and use of musculofascial flaps, utilizing both open and laparoscopic approaches.2 
However, there is no clear-cut consensus regarding the optimal hernia repair technique, 
particularly in complex hernia repair cases where patient co-morbidities exist and a high risk 
of infection is present.    
 
Simple suture repair has been associated with a high risk of hernia recurrence, with reports 
ranging from 10% to 55%, and has been nearly abandoned for the repair of hernias which are 
greater than five centimeters (cm) in size.4, 5, 6, 7 As a result, many ventral hernia repair 
procedures involve the use of a mesh material.    
 
Synthetic mesh repair procedures, either open or laparoscopic, have been reported to lead to 
fewer recurrences compared to primary repairs.8, 9, 10 Improved outcomes are believed to be 
related to reduced tension on the fascial edges and sutures when mesh is used in hernia repair 
procedures.  However, complex cases and large abdominal wall defects continue to pose a 
challenge to surgeons.  Factors such as patient co-morbidities, defect size, location, tissue 
viability and degree of contamination are included in a surgeon’s assessment and decision-
making process.11 These large abdominal wall defects have been associated with recurrence 
rates of up to 46%.12 
 
Despite reducing hernia recurrence rates, the use of synthetic mesh has been associated with 
complications such as infection, adhesions, fistulae, and foreign body reactions including 
increased inflammation and/or connective tissue deposition.13 
 
Non-absorbable meshes can lead to complications related to the body’s reaction to the 
persistent foreign mesh material resulting in foreign body sensations including discomfort 
and chronic pain, which is described by the International Association for the Study of Pain as 
pain lasting for 3 months or greater following hernia repair.14, 15 
 
Ideally, an absorbable mesh would provide adequate structural support throughout the 
healing process and would be fully absorbed when the wound has completely healed, thereby 
potentially reducing the chances for complications associated with the persistence of non-
absorbable mesh material.  However, the development of absorbable mesh products has faced 
challenges related to the rate of absorption with complications arising when the mesh product 
is absorbed too quickly.  Rapid absorption does not support sufficient healing if structural 
reinforcement is diminished during the tissue repair period.  An absorbable mesh should 

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retain its functional strength for a sufficient period of time to allow native cellular ingrowth 
tissue remodeling, maturation of collagen, and gradual shift of mechanical load. 
 
Phasix™ Mesh is a commercially available medical device in the US. It is a resorbable mesh 
prepared from poly-4-hydroxybutrate (P4HB) which has been studied for use as a biomaterial 
for a number of applications in medical devices and tissue engineering due to favorable 
mechanical properties, biocompatibility and desirable degradation times.16, 17, 18 Using 
standard measures of mechanical strength (suture pull-out, tear and ball burst strength) 
Phasix™ Mesh is comparable in performance to traditional polypropylene mesh. Pre-clinical 
implantation studies indicate that the resorption of the Phasix™ Mesh fibers is minimal 
throughout the 12 week expected period of healing and up to ~26 weeks post-implantation.  
Resorption of the fibers is essentially complete in 12-18 months.19, 20  Given the long-term 
strength retention observed in preclinical studies, it is anticipated that Phasix™ Mesh may 
result in low recurrence and complication rates with minimal pain and discomfort when used 
for hernia repair.  
 
A porcine bridging hernia repair study demonstrated that Phasix™ Mesh could perform as a 
durable scaffold for soft tissue repair when spanning a surgical defect.20  The results of the 
52-week study showed that the repair site had significantly greater mechanical repair 
strength, as compared to native abdominal wall.  This persisted even after significant 
Phasix™ Mesh resorption (as measured by molecular weight).  Phasix™ Mesh showed an 
initial mild-moderate host inflammatory response, that declined to mild over 52 weeks. 
Neovascularization (angiogenesis) and new collagen deposition were evident at 6, 12, 26 and 
52 weeks.  In a 24-week rat study, histological analyses of the repair site demonstrated that 
some competitive meshes had a greater overall host inflammatory response, some had less of 
a response and one had a very similar response, to Phasix™ Mesh.21 In the same study, 
histological analyses demonstrated similar variability on measures of host fibrotic response. 
 
MonoMax® suture (B. Braun Melsungen AG) is a product made from the same polymer as 
Phasix™ Mesh. A twelve month, 150-patient, multicenter clinical study demonstrated the 
safety and efficacy of MonoMax® for abdominal wall closure.22 Wound infection and wound 
dehiscence rates were compared between MonoMax® and an historical control (7.3% versus 
11.3% combined). One year after surgery, the rate of incisional hernias was similar 
comparing the two groups: 21 patients (14.0%) in the MonoMax® group compared to 30 
patients (21.3%) in the control. 
  
This post-approval clinical study is being conducted to evaluate the use of Phasix™ Mesh in 
primary ventral, incisional or multiply-recurrent hernia repair in patients with a higher level 
of risk as defined by the presence of 1 or more common pre-existing conditions. Patients who 
receive a Phasix™ Mesh implant will be followed for 60 months. 
 
 

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1.2 
Rationale 
 
This study is intended to evaluate the use of Phasix™ Mesh for primary ventral, incisional 
and multiply-recurrent incisional hernia repair amongst subjects at high risk for 
complications.  This protocol version (4.0) is intended to capture longer term data (through 
60 months) on all eligible subjects.  The protocol’s follow up period was not extended due to 
safety related concerns or trends. 
 
1.3 
Device Descriptions 
 
1.3.1 Phasix™ Mesh  
 
The Phasix™ Mesh (Davol, Inc.) is a resorbable mesh prepared from P4HB.  P4HB is 
produced from a naturally occurring monomer and is processed into monofilament fibers and 
knitted into a surgical mesh.  Phasix™ Mesh degrades through a process of hydrolysis and a 
hydrolytic enzymatic digestive process.  It was developed to minimize the variability of 
resorption rate (loss of mass) and strength and provide support throughout the expected 
period of healing. 
 
Pre-clinical implantation studies indicate that the resorption of the Phasix™ fibers is minimal 
throughout the 12-week expected period of healing and up to about 26 weeks post 
implantation.  Resorption of the fibers is essentially complete in 12 to 18 months.19, 20 
 
Phasix™ Mesh has been commercially available in the US since 2012 and is indicated to 
reinforce soft tissue where weakness exists, such as the repair of hernia or other fascial 
defects that require reinforcement or bridging material to obtain the desired surgical result.  
Because Phasix™ Mesh is fully resorbable, it should not be used in repairs where permanent 
wound or organ support from the mesh is required.  A full description of Phasix™ Mesh is 
included in the product’s Instructions for Use (IFU) (Appendix 2). 
 
2 
STUDY OBJECTIVES  
 
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 multiply-
recurrent 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. 
The study end points are described below. 
 
3 
STUDY ENDPOINTS 

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There are two primary endpoints, hernia recurrence rate and surgical site infection (SSI) rate, 
and six secondary endpoints: 
 
3.1 Primary Endpoints: 
 
1. Hernia Recurrence Rate 
 
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 
  
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 (Appendix 3). 
 
3.2 Secondary Endpoints: 
 
1. Pain - Visual Analog Scale (VAS)  
2. Device related adverse event incidence 
3. Rate of reoperation due to the index hernia repair 
4. Quality of life assessments (Carolinas Comfort Scale® and SF-12® - 12-item short 
form health survey) 
5. Surgical procedure time as measured from incision to closure (skin to skin) 
6. Length of stay 
 
4 
STUDY DESIGN 
 
This is a prospective, multi-center open-label study designed to collect additional data on 
safety, performance and effectiveness of Phasix™ Mesh for primary ventral or incisional or 
multiply-recurrent hernia repair. Follow-up visits will be conducted at 1, 3, 6, 12, 18, 24, 30, 
36, 42, 48, 54, and 60 months following surgery. See Section 6 for a detailed schedule of 
study visits and procedures.   
 
 
 

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5 
STUDY POPULATION 
 
5.1 
Number Of Subjects 
 
This study is projected to enroll up to 120 subjects at approximately 16 US sites. 
 
5.2 
Eligibility Criteria – Enrollment Period 
 
5.2.1 Inclusion Criteria 
 
The subject must meet all of the criteria listed below to be enrolled in the study: 
1. Subject must be 18 years of age or older 
2. Subject or subject’s legally authorized representative must be willing to give written 
informed consent 
3. Subject must be diagnosed with primary ventral, incisional hernia or multiply- 
recurrent (not to exceed 3 recurrences) ventral or incisional hernia 
4. Subject must have a hernia greater than 10 cm2 and ≤350 cm2 
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) 
6. Subject is expected to meet the criteria for a Class I wound as defined by the CDC 
(Appendix 4) 
7. Subjects must have 1 or more of the following pre-study conditions: 
a. Body Mass Index (BMI) between 30-40 kg/m2, inclusive 
b. Active smokers (if attempts to quit smoking within two weeks of surgery have 
failed and the patient is still an active smoker at the time of surgery) 
c. COPD presence on patient self-report 
d. Diabetes mellitus 
e. Immunosuppression  
f. Coronary Artery Disease 
g. Chronic corticosteroid use: greater than 6 months systemic use 
h. Serum albumin less than 3.4 g/dL 
i. Advanced age: 75 years or older 
j. Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL 
 
5.2.2 Exclusion Criteria 
 
The subject must be excluded from study enrollment if any of the following criteria are met: 
 
1. Subject has had 4 or more previous hernia repairs (of the index hernia) 
2. The subject has peritonitis 
3. The subject is on or suspected to be placed on chemotherapy medications during any 
part of the study 
4. The subject’s Body Mass Index (BMI) is greater than 40 kg/m2 

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5. The subject has cirrhosis of the liver and/or ascites 
6. Subject is American Society of Anesthesiology Class 4 or 5 
7. Subject is known to be infected with human immunodeficiency virus (HIV) 
 
8. Subject has a life expectancy of less than 2 years at the time of enrollment 
9. Subject has any condition that, in the opinion of the Investigator, would preclude the 
use of the study device, or preclude the subject from completing the follow-up 
requirements 
10. Subject’s hernia repair utilizes intra-abdominal mesh placement 
11. Subject has a surgical wound classified as Class II (Clean-Contaminated), Class III 
(Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 
4) 
12. Subject has an active or latent systemic infection 
13. Subject requires surgical bridge repair as the sole repair  
14. Subject is pregnant or has plans to become pregnant during the study period or is 
currently breastfeeding 
15. Subject has enrolled in another clinical study within the last 30 days 
16. Subject is part of the site personnel directly involved with this study 
17. Subject has a known allergy to the test device or component materials (patients with 
known allergies to tetracycline hydrochloride or kanamycin sulfate should be 
avoided). 
 
5.3 
Eligibility Criteria – Extension  
 
5.3.1 Inclusion Criteria 
 
The subject must meet the criteria listed below to be enrolled in the study: 
 
1. Subject or subject’s legally authorized representative must be willing to give written 
informed consent 
 
5.3.2 Exclusion Criteria 
 
The subject must be excluded from study enrollment if any of the following criteria are met: 
 
1. Abdominal surgeries where the index procedure site was cut through  
6 
STUDY PROCEDURES 
 
6.1 
Subject Screening and Baseline Evaluation 
 
Subjects with a diagnosis of a primary ventral or incisional hernia or multiply-recurrent 
hernia requiring surgical repair to close the defect will be screened for potential eligibility 
against the study protocol inclusion and exclusion criteria, utilizing ordinary standard of care 

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procedures (e.g. physical examination, blood work, medical evaluation) within 30 days of the 
date of consent.  This may include a full anesthetic work-up customary for hernia repair 
procedures.  Any other standard of care examination or evaluation within 30 days of the date 
of consent may be considered baseline for study purposes.  Prior medical records 
documenting these tests, examinations and evaluations may be used as the source documents 
for the baseline visit. 
 
During the screening and recruitment process, the Investigator will be responsible for 
describing the nature of the clinical study, verifying that the eligibility criteria have been met, 
and obtaining informed consent.  Written informed consent and a Health Insurance 
Portability and Accountability Act (HIPAA) waiver must be obtained prior to performance of 
any protocol specific procedures. 
 
The following screening/baseline procedures will be conducted and documented. 
 
6.1.1 Informed Consent  
 
The investigator will explain the study to the subject, answer all of the subject’s questions, 
and obtain written informed consent in a language in which the subject is fluent before the 
collection of any study data or performance of any study procedures.  
 
The subject (or subject’s legally authorized representative) must be willing and able to sign 
and date the informed consent form (ICF) prior to the collection of study data or performance 
of any study procedures. The original, signed informed consent will be retained with the 
subjects’ records and a copy provided to the subject. 
 
6.1.2 Enrollment 
 
Subjects who sign an informed consent will be considered enrolled in this study.  Subjects 
who provide consent for participation but do not meet all of the study eligibility criteria and 
do not receive the test device will be considered screen failures. 
 
6.1.3 Eligibility 
 
The subject’s eligibility for study enrollment will be reviewed and documented on the 
appropriate eCRF.  At the time of screening, a related progress note must be entered in the 
source documentation to indicate that all eligibility criteria were reviewed and screening 
results noted. Final eligibility will be determined intraoperatively. 
 
Subjects who fail to meet eligibility criteria should be considered screen failures and treated 
according to the Investigator’s standard of care. Data are to be collected for screen failure 
subjects from the time the ICF is signed until the subject is deemed a failure. At a minimum, 
subject demographics and the reason for failure must be collected; adverse events (AEs) will 
also be collected and followed through satisfactory resolution or stabilization.  

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6.1.4 Assignment of Subject Screening Number 
 
Subject numbers will be assigned in sequential order, consisting of six digits where the first 
three digits designate the study site and the last three digits designate the subject number (i.e., 
subject number 101 001 will be the first subject at site 1; 101 002 will be the second subject 
at site 1, etc.). 
 
6.1.5 Blinding 
 
The study is an open-label study with a single treatment condition. Subjects, investigator 
(and surgeon) will be not be blinded to the study treatment.  
 
6.1.6 Demographics and Medical History 
 
The subject's medical history and demographic information will be documented on the 
appropriate eCRF.  Demographic information will include gender, date of birth, race and 
ethnicity.   
 
6.1.7 Physical Examination 
 
A standard physical exam, appropriate to subjects about to undergo abdominal surgery, will 
be performed by the physician.  Height and weight measurements will be recorded to allow 
for the calculation of BMI.  The subject’s ability to participate and meet the follow-up 
requirements will be established.  
 
6.1.8 Concomitant Pain Medication Usage 
 
Prescription and over the counter (OTC) pain medication must be recorded in the source 
documentation and in the eCRF. All current pain medication will be captured at baseline.  
Hernia associated pain medication only will be captured at 12, 24, 36, 48, and 60 months. 
 
6.1.9 Patient Reported Outcome Assessments 
 
Subjects will complete the Pain VAS, Carolinas Comfort Scale® and SF-12® to measure pain, 
discomfort and quality of life at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months.   
 
6.2 
Surgical Procedure 
 
6.2.1 General Procedures 
 

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All subjects will undergo an open ventral repair of hernias. The size of the hernia is an 
intraoperative inclusion criterion and must be greater than 10 cm2 and ≤350 cm2.  All other 
intraoperative exclusion criterion should be verified (e.g., a surgical wound classified as 
clean-contaminated, contaminated or dirty; absence of an active or latent systemic infection; 
presence of peritonitis; a hernia bridge as the sole repair procedure). Defect closure must be 
confirmed.  
 
The surgical technique will require retro-rectus or onlay placement (using absorbable suture) 
with or without Component Separation Technique (CST). Subjects will be administered 
antibiotics according to hospital protocol.  
 
Subjects are prepared to undergo hernia repair following the instructions supplied by the 
manufacturers. The IFU for Phasix™ Mesh device is presented in Appendix 2.  
 
Phasix™ Mesh will be placed in the retro-rectus space with absorbable mesh fixation. The 
peritoneum should remain posterior to the mesh upon completion of mesh placement. 
Phasix™ Mesh may be cut to shape or size desired for each specific application. To prevent 
recurrence when repairing hernias, a mesh larger than the defect is required to ensure 
adequate coverage. The mesh is to be positioned so its edges extend beyond the margins of 
the defect by at least 5 cm. It is recommended that fixation be placed at approximately 5 to 6 
cm intervals (6 to 12 resorbable sutures) around the periphery of the mesh. The edges are 
then fixated to assure proper closure under correct tension.  
 
The procedure may include CST to obtain site closure. All incisions will be closed with 
staples and/or sutures and wounds will be dressed with sterile occlusive dressings. 
  
6.2.2 Component Separation Technique Surgery 
 
Prophylactic antibiotics will be administered according to hospital protocol. If a prior hernia 
repair utilizing mesh is in the affected area, every effort should be made to remove any mesh 
remaining. Once all of the dissection is performed and all of the hernia has been exposed, the 
largest vertical and transverse dimensions should be recorded. 
 
If the CST is utilized, the surgical technique will be a modification of the “component 
separation technique” by Ramirez et al. with the graft being implanted into the tissue plane of 
the surgeon’s preference, according to the following: Separation of components may be done 
via open, posterior or endoscopic/minimally invasive technique as described below.8, 23  
 
6.2.2.1 Open Technique 
  
After entering the abdominal cavity, adhesiolysis is performed to dissect free any intra-
abdominal contents from the abdominal wall.  The skin and subcutaneous fat are dissected 
free from the anterior sheath of the rectus abdominal muscle and the external oblique 
muscle.  The external oblique is separated through the aponeurosis approximately 1-3 cm 
from the edge of the rectus, or through the muscle.  If the hernia is subxiphoid in position, 

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release must be done above the rib cage and come across the rectus sheath and muscle at the 
level of where the pectoralis meets the rectus.  The external oblique muscle is separated from 
the internal oblique muscle, as far laterally as possible (aiming to the anterior axillary line), 
above and below the hernia by approximately 5 cm.    
  
6.2.2.2 Posterior Technique  
 
Posterior component separation with transversus abdominis release (TAR): Starting in the 
upper third of the abdomen, about 0.5 cm medial to the anterior/posterior rectus sheath 
junction (linea semilunaris), the posterior rectus sheath is incised to expose the underlying 
transversus abdominis muscle. The muscle is then divided along its entire medial edge using 
electrocautery. The use of a right-angled dissector significantly facilitates this release and 
minimizes injury to the underlying transversalis fascia and peritoneum. Transection of the 
medial edge of the transversus abdominis muscle allows for entrance to the space between 
the transversalis fascia and the lateral edge of the divided transversus abdominis muscle. The 
retromuscular space is bluntly developed further laterally to as far as the lateral border of the 
psoas muscle to allow for a reinforcement of a visceral sac with a large mesh. Also, if 
needed, this dissection may be extended superiorly above the costal margin and inferiorly to 
expose both myopectineal orifices. 
 
6.2.2.3 Endoscopic/Minimally Invasive Technique 
  
Make a 2 cm incision in the upper abdomen in a location that is convenient for release (such 
as directly over the costal margin at the level of the mid clavicular line, or at the tip of the 
11th rib). Please note: this incision may occasionally need to be placed further lateral to 
ensure the incision is lateral to the linea semilunaris.  Dissect down to the level of the 
external oblique muscle.  Separate the external oblique muscular fibers (this allows for 
visualization of the underlying internal oblique aponeurosis below).  Advance a balloon 
dissector between the internal and external oblique muscle down to the level of the inguinal 
ligament.  Insufflate the balloon under endoscopic visualization.  Remove the dissecting 
balloon and replace with a trocar (first port).  Infuse the lateral abdominal cavity with gas, 
such as carbon dioxide. Place a second port into the lateral abdominal cavity to allow for 
dissection.  A third port may be used to facilitate easier access to parts of the anatomy.  If 
performing a minimally invasive technique multiple incisions may be used to visualize and 
release the external oblique under direct visualization.  Use cautery or alternatively ultrasonic 
dissection to divide the external oblique muscle from the costal margin down to the inguinal 
ligament.  Please note: extending the dissection to the level of Scarpa’s fascia results in even 
greater abdominal wall advancement.  This technique is generally performed bilaterally. 
  
6.2.2.4 Open or Endoscopic Technique 
  
If necessary, resect/debride the edges of the rectus fascia to ensure apposition of healthy 
well-vascularized tissue as the midline is closed.  Care must be taken not to damage the 

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blood supply and the nerves that run between the internal oblique and transverse muscle and 
enter the rectus abdominal muscle at the posterior side. 
  
Closure should be performed with permanent or long lasting sutures every 1-2 cm between 
sutures, for example with an interrupted Figure-8 closure or running stitch.  The surgeon 
should make every effort to close the fascial edges including the use of the component 
separation technique.  If the fascia cannot be closed, the peritoneum of the hernia sac should 
have been preserved so that this can be closed over the Phasix™ to provide vascularized 
tissue.   
  
If a previous scar of skin is present, the scar should be excised.  Scarification products may 
be used to diminish seroma formation.  The fascial and subcutaneous layer should be closed 
with sutures.  The skin should be closed with staples and/or sutures.  When skin closure can’t 
be achieved, a wound vac can be used.   
 
6.2.3 Postoperative Care  
 
Subjects will be discharged when ambulatory and they have satisfied post anesthesia care 
criteria.  Subjects should be instructed to avoid lifting in excess of ten pounds for six 
weeks.  Early ambulation should be encouraged.  Postoperative analgesics will be provided 
to all subjects. Subjects will be given a prescription for hydrocodone/acetaminophen tablets 
or an equivalent medication based on local prescribing patterns, medication allergies, and 
subject needs.  Subjects will be instructed to keep the incisions covered and dry for 48 hours 
after which time the dressing may be removed.  Subjects should be instructed to keep the 
incisions dry except for showers for two weeks.  Subjects should also be instructed to call the 
Investigator for fever in excess of 101°F, redness or swelling at the incisions or surgical site, 
surgical site drainage, or worsening pain.  
 
If for any reason the mesh is removed and a mesh infection is suspected, routine culture, at 
the site of the wound, area of contamination, or potential contamination, obtained via each 
site’s normal 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.   
 
6.2.4 Surgical Details 
 
Surgical details will be recorded and entered in the appropriate source documentation and 
eCRF(s).  Details will include but may not be limited to procedure date, start/stop times, 
procedure related complications, and AEs.   
 
 
 
6.3 
Subject Follow-up 
 

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6.3.1 Subjects Not Implanted and Surgical Repair Failures 
 
Subjects who are screened but do not have the test device placed should be considered a 
screen failure and treated per hospital standard of care. Screen failure subjects who 
experience a protocol defined AE will be followed through satisfactory resolution or 
stabilization of the event.  
 
Reason for failure of the surgical repair procedure, as well as all information outlined in 
Section 6.2.3 must be recorded in the source documentation.      
 
6.3.2 Subjects Successfully Implanted 
 
Subjects successfully implanted with Phasix™ Mesh will be followed as per the protocol 
defined follow-up procedures (see Table of Study Events).  
 
 
 

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6.3.3 Assessments 
 
Subjects should report to their respective study site for follow-up visits at the following 
times: 
 
 1 month assessment:   Day 30 + 7 days post device placement 
 3 month assessment:   Day 90 + 30 days post device placement 
 6 month assessment:   Day 180 + 30 days post device placement 
 12 month assessment: Day 365 + 30 days post device placement 
 18 month assessment: Day 545 + 30 days post device placement 
 24 month assessment: Day 730 + 30 days post device placement 
 30 month assessment: Day 910 + 30 days post device placement 
 36 month assessment: Day 1095 + 30 days post device placement 
 42 month assessment: Day 1275 + 30 days post device placement 
 48 month assessment: Day 1460 + 30 days post device placement 
 54 month assessment: Day 1640 + 30 days post device placement 
 60 month assessment: Day 1825 + 30 days post device placement 
 
At each study visit (see exception below for the 30, 42, and 54 month assessments) the 
following procedures will be completed and these data recorded in source documentation and 
on the eCRF:  
 
 Physical exam to check for hernia recurrence and surgical complications. 
Note: If the subject undergoes imaging for any reason and a recurrent hernia is 
identified, it must be recorded. 
 Surgical Pain Scale (VAS)  
 Carolinas Comfort Scale® 
 SF-12®  
 Concomitant pain medication usage (all pain medication will be captured at baseline.  
Hernia associated pain medication only will be captured at 12,24, 36, 48, and 60 
months) 
 Assessment of AEs/complications 
 
6.3.3.1 Roll in Visit 
The Roll in Visit should be completed in clinic where eligible subjects should be re-
consented and confirmed that no abdominal surgeries were performed at the site of 
the index procedure.  Sites with IRB approval of the extension study may complete 
the Roll in Visit with eligible subjects in combination with the 36 Month Follow Up 
visit. 
 
6.3.3.2 30 Month Follow Up (910 days ± 30 days), 42 Month Follow Up (1275 ± 30 
days), 54 Month Follow Up (1640 days ± 30 days) 
 

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A telephone contact should be scheduled with the subject and completed by the 
Investigator.  The following information will be collected: 
 Symptoms suggestive of hernia recurrence 
 Symptoms suggestive of surgical site infections 
 Any adverse events relating to the device, procedure, or abdominal space 
since the last study assessment 
 
If the Investigator determines the responses provided by the subject demands a 
physical exam be conducted, an office visit will be scheduled.  The office visit will be 
included as part of the 30, 42 or 54 Month Follow Up assessment (not an 
Unscheduled Visit) and will require all study assessments listed in Section 6.3.3 to be 
completed.  
 
6.3.4 Unscheduled Visits 
 
If the subject has an evaluation related to the abdomen or abdominal organs at any time 
during the subject’s study follow-up period, the subject will undergo unscheduled visit study 
procedures (see Table of Study Events).  
 
 

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6.4 
TABLE OF STUDY EVENTS 
 
Study Procedure 
Screening 
and Baseline 
Period 
Surgery 
1 Month 
Visit 
3 Month 
Visit 
6 Month 
Visit 
12 Month 
Visit 
18 Month 
Visit 
24 Month 
Visit 
30 Month 
Visit3 
36 Month 
Visit 4 
Visit Window (days) 
Within 30 
days of 
consent 
0 
30 + 7 
90 + 30 
180 + 30 
365 + 30 
545 + 30 
730 + 30 
910 + 30 
1090 + 30 
Describe study to 
potential subject 
X 
 
 
 
 
 
 
 
 
 
Obtain informed consent 
X 
 
 
 
 
 
 
 
 
 
Verify eligibility criteria 
X 
X1 
 
 
 
 
 
 
 
 
Collect demographics and 
medical history 
X 
 
 
 
 
 
 
 
 
 
Conduct physical 
examination 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
Placement Procedure of 
Device 
 
X2 
 
 
 
 
 
 
 
 
Surgical Pain Scale 
(VAS) 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
Carolinas Comfort Scale® 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
SF-12® 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
Collect adverse events/ 
complications 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Collect pain medication 
usage 
X 
 
 
 
 
X 
 
X 
 
X 
Schedule next follow-up 
visit 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
1 Intraoperative verification of hernia size 
2 See Section 6.2 for surgical procedure details 
3 Investigator will determine whether clinic visit is necessary based on subject responses.  Site will complete all study procedures at clinic visit. 
 
 

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6.4 
TABLE OF STUDY EVENTS (cont.) 
 
Study Procedure 
Roll in Visit4 
42 Month 
Visit 
48 Month 
Visit 
54 Month 
Visit 
60 Month 
Visit3 
Unschedule
d 
Visit/Early 
Termination 
Visit Window (days) 
Re-consent 
1275 + 30 
1460 + 30 
1640 + 30 
1825 + 30 
 
Describe study to subject 
X 
 
 
 
 
 
Obtain informed consent 
X 
 
 
 
 
 
Verify eligibility criteria 
X 
 
 
 
 
 
Collect demographics and 
medical history 
 
 
 
 
 
 
Conduct physical 
examination 
X 
 
X 
 
X 
X 
Placement Procedure of 
Device 
 
 
 
 
 
 
Surgical Pain Scale 
(VAS) 
X 
 
X 
 
X 
X 
Carolinas Comfort Scale® 
X 
 
X 
 
X 
X 
SF-12® 
X 
 
X 
 
X 
X 
Collect adverse events/ 
complications 
X 
X 
X 
X 
X 
X 
Collect pain medication 
usage 
X 
 
X 
 
X 
 
Schedule next follow-up 
visit 
X 
X 
X 
X 
 
 
4 Roll in Visit should be completed in the clinic and may be combined with the 36 Month F/U visit

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6.5 
Withdrawal and/or Early Termination 
 
Subjects will be informed that they have the right to withdraw from the study at any time, 
without affecting their future care.  Subjects may also be discontinued from the study, if the 
Investigator determines it is in the best interest of the subject.   
 
Additionally, subjects may be discontinued for reasons including, but not limited to the 
following: 
 Consent is withdrawn 
 Lost to follow-up (LTF) 
 Death 
 Investigator withdrawal of subject 
 Other  
 
A subject is considered LTF if the investigational site personnel are unable to locate the 
subject despite two documented attempts to notify the subject via telephone and a third 
attempt by certified mail. 
 
A subject is considered an Early Termination (ET), if discontinuation occurs after successful 
implant of the test device.  The site should attempt to bring the subject back to complete all 
ET visit study procedures (see Table of Study Events).   
 
Once a subject discontinues from the study, the Investigator must complete a Study 
Completion eCRF and the reason for subject discontinuation must be fully documented. 
 
7 
STATISTICAL METHODS 
 
This section describes the planned statistical analyses for this study. A detailed Statistical 
Analysis Plan (SAP) will be completed and placed on file prior to database lock. The SAP 
will contain a comprehensive explanation of the methodology used in the statistical analyses 
described below.  
 
7.1 
Study Hypothesis 
 
There is no formal statistical hypothesis for this observational post-market study.  The study 
will follow eligible, high risk patients implanted with the Phasix™ Mesh for hernia repair in 
order to assess long-term recurrence and surgical site infection rates. 
 
 
 

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7.2 
Sample Size Considerations 
 
This study is projected to enroll up to 120 subjects at approximately 16 sites.  The sample 
size of 120 subjects is based on potential adequacy of data to meet the study objectives. It is 
not based on any statistical consideration. 
 
 
 
7.3 
Data Analysis 
 
The Intent-to-treat (ITT) population consists of all enrolled subjects who have signed the 
Informed Consent Form. The modified ITT (mITT) population is defined as those subjects in 
the ITT population in whom Phasix Mesh has been implanted.  A Per-Protocol (PP) 
population may be created if there are subjects who have any major protocol deviations. The 
PP population will consist of any subjects in the mITT population who do not have any major 
protocol deviation. The protocol deviations that are considered to have a “major” grade will 
be defined a priori in the analysis plan. All analyses will be primarily based on the mITT 
population. Primary analyses may be performed for PP population as well. 
 
Demographics and baseline characteristics will be summarized using the ITT population. 
Summary statistics for categorical variables will include frequency counts and percentages 
and for continuous variables mean, standard deviation, minimum, median and maximum. 
 
The primary endpoints of hernia recurrence rate and surgical site infection rate will be 
reported by visit along with their 95% confidence intervals based on the mITT population. 
The calculation of rates at each time point will be based on available data at the time point. 
Missing data will not be imputed. Additionally, a Kaplan-Meier survival analysis will be 
performed.  
 
The secondary endpoints of VAS pain scale, Carolinas Comfort Scale and SF-12® will be 
summarized based on the mITT population with mean, standard deviation, minimum, median 
and maximum presented by visit. Other secondary endpoints will be summarized as 
appropriate. 
 
Subjects who do not have Phasix™ Mesh implanted will have their AEs summarized 
separately and their outcome data will not be collected or analyzed.  
 
Exploratory analyses on subpopulations may be performed. 
 
8 
ADVERSE EVENTS 
 
The Investigator is responsible for the detection and documentation of events meeting the 
criteria and definition of an AE or SAE, as provided in this protocol. All AEs that occur 
during the study should be treated with established standards of care that will protect the life 
and health of the study subjects.   

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AEs will be collected from the time of enrollment (AE onset after signing ICF) through the 
end of study participation (either study completion or early discontinuation) and will be 
documented in the medical record or source document and on study eCRFs.  All events will 
be followed to satisfactory resolution or stabilization.  
 
8.1 
Definition Of Adverse Events  
 
In this study, an 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. Abnormal laboratory results are not to be 
considered AEs unless the results are accompanied by clinical signs or symptoms.  The 
Investigator will assess the relationship of an AE to the study device or procedure as 
described in Section 8.5. 
 
8.2 
Definition of Serious Adverse Events  
 
An event will be classified as a serious adverse event (SAE) if it meets the definition of 
serious injury in the Medical Device Reporting Regulation [21 CFR 803.3] as listed below: 
 
 results in, or contributes to, a death or serious injury; 
 is life-threatening (i.e., the subject was at risk of death at the time of the 
event); 
 requires in subject hospitalization or prolongation of existing 
hospitalization; 
 results in persistent disability or incapacity (i.e., permanent impairment of 
a body function or permanent damage to a body structure);  
 necessitates medical or surgical intervention to prevent one of the 
outcomes listed above in this definition (i.e., to preclude permanent 
impairment of a body function or permanent damage to a body structure) 
 
NOTE:  The term serious is not synonymous with severity, which may be used to describe 
the intensity of an event experienced by the subject. 
 
8.3 
Relationship of Adverse Event to Device/Procedure 
 
Assess each AE for its relationship to the device (Phasix™) or surgical procedures as 
follows: 
 
 Device: This category should be restricted to AEs directly attributable to 
devices used as part of the study procedure. 
 

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 Procedure:  This category should be restricted to AEs directly attributable 
to the study device surgical procedure.  
 
Use the following categories for assigning the certainty of the relatedness: 
 
 Definitely Related:  An AE is definitely related if it is obvious, certain or 
there is little doubt regarding the relationship. 
 
 Possibly Related:  An AE is possibly related if it is capable of being 
related but relatively unlikely. 
 
 Not Related:  An AE is not related if it is determined that there is no 
plausible association. 
 
 
8.4 
Severity Of Adverse Events 
 
Each AE should be assessed for its severity, or the intensity of an event, experienced by the 
subject. 
 
 Mild:  Awareness of a sign or symptom that does not interfere with the subject’s 
activity or is transient and is resolved without treatment or sequelae. 
 
 Moderate:  May interfere with the subject’s activity and require additional 
intervention and/or treatment, and may have additional sequelae. 
 
 Severe:  Significant discomfort to the subject and/or interferes with the subject’s 
activity.  Additional intervention and/or treatment are necessary.  Additional sequelae 
occur.  Severe is used to describe the intensity of an event experienced by the subject. 
 
8.5 
Reporting Of Adverse Events 
 
If an AE occurs, all sections of the appropriate eCRF must be completed. 
 
All Investigator-judged device- or procedure-related AEs that occur (whether serious or not) 
must be reported to Davol Inc. Field Assurance using the contact information provided in 
Section 9, within 24 hours of becoming aware of the event. 
 
Additionally, all SAEs (whether device- or procedure-related or not) must be reported to the 
Sponsor within 24 hours of becoming aware of the event.  
 

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It is the responsibility of the Investigator to inform the Institutional Review Board (IRB) of 
AEs according to IRB requirements. The Sponsor will report to the Food and Drug 
Administration (FDA) as appropriate after becoming aware of a reportable event. 
 
 
9 
MECHANICAL FAILURES, MALFUNCTIONS AND DEFECTS  
 
The Investigator will record if the surgical mesh device used in the study procedure failed to 
meet its performance specifications whether due to mechanical failure, malfunction or 
defects.  This applies to: devices used in the subject, devices in which the package was 
opened but the device was not used for implantation in the subject, or devices with which 
implantation was attempted, but the device did not remain (was not used) in the subject. 
 
A recurrence (unless it is in a different location than the study hernia) is considered a device 
failure if the recurrence is clearly device related, and not procedure related or an issue of 
patient mismanagement (e.g., use of a Vacuum Assisted Closure (VAC) system for too long; 
mesh used was too small to adequately cover the defect), as determined by the Investigator. 
 
All mechanical failures, malfunctions, missing components, foreign matter inclusion or any 
other defects of the study device or any components of the device kit that do not perform to 
specifications must be promptly reported to the Davol Field Assurance Department:  
 
Field Assurance Department 
e-mail: Davol.FieldAssurance@crbard.com 
 
Telephone: 800-556-6756 
Sarah Hardy – Ext 8422 
e-mail: Sarah.Hardy@crbard.com 
 
The event must also be documented on the Device Failure eCRF and the malfunctioning 
device promptly returned to the manufacturer.   
 
10 CASE REPORT FORMS  
 
The Investigator is responsible for ensuring the accuracy and completeness of all study 
documentation.  All clinical study data will be recorded in the eCRFs provided to the 
investigational site.  
 
11 RISK/BENEFIT ANALYSIS 
 
Subjects participating in this study will require hernia repair surgery as part of their standard 
of care.  The device utilized in this study is commercially available, has 510(k) clearance 
from the US FDA and will be used in accordance with the indications in labeling which are 
in effect during the study period.  This study will not pose any additional potential risk to the 

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health, safety, or welfare of the subject.  The risks associated with hernia repair and Phasix™ 
Mesh are described in full in the IFUs (Appendix 2). 
 
There is no immediate benefit to the subject for participation in this study.  Collection and 
analysis of the data generated in this study may be of benefit to future subjects who require 
hernia repair. 
 
12 ADMINISTRATIVE REQUIREMENTS 
 
This study will be conducted in accordance with the Declaration of Helsinki, HIPAA 
requirements, Good Clinical Practices (GCP), and applicable FDA regulations (21 CFR parts 
50, 54, 56 and will be exempt from the requirements of 21 CFR part 812, as per 21 CFR part 
812.2(c)(2), as the device has been cleared by the FDA for commerce and will be used as per 
the IFU.)   
 
12.1 Publication Policy  
 
At the conclusion of the study, a multi-center article may be prepared for publication in a 
scientific journal. The publication of the principal results from any single-center experience 
within the study is not allowed until the preparation and publication of the multi-center 
results. Exceptions to this rule require the prior approval of Davol.  The analysis of other pre-
specified and non-pre-specified endpoints will be performed by Davol or its designee.  Such 
analyses, as well as other proposed investigations will require the approval of Davol.  Davol 
anticipates the possibility of secondary manuscripts with principal authorship. For purposes 
of timely abstract presentation and publication, such secondary publications will be delegated 
to the appropriate principal authors, and final analyses and manuscript review for all multi-
center data will require the approval of Davol. 
 
12.2 Investigator Selection 
 
The Investigator must be of good standing as an Investigator and knowledgeable in relevant 
areas of clinical research to ensure adherence to the requirements of the protocol, including 
the protection of human subjects.  Other site personnel must have appropriate research 
experience and infrastructure to ensure adherence to the protocol and enrollment of sufficient 
numbers of evaluable subjects.  The curriculum vitae (CV) of the Investigator will be 
maintained in the Sponsor files as documentation of previous medical training, and federal 
databases will be searched to ensure that the Investigator and/or the site are not prohibited 
from engaging in federally Sponsored clinical research.  The Principal Investigator will sign 
the signature page of this protocol, agreeing to comply with all applicable government 
regulations and the requirements of this study. 
 
12.3 Regulatory and Ethical Considerations 
 

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12.3.1 Institutional Review Board Approval  
 
Before commencement of the study, the Investigator must provide Sponsor with written 
documentation of IRB approval.  This approval must refer to the ICF and the study by both 
the title and the protocol number assigned by Sponsor.  The Investigator, if a member of the 
IRB, is not to participate in the approval decision for this study.  This non-participation 
should be noted in the approval letter. 
 
The IRB must give written renewal of the original approval at least annually to continue the 
study.  A copy of the written renewal must be provided to Sponsor. 
 
12.3.2 Informed Consent and HIPAA Authorization 
 
Prior to the procedure, the Investigator (or designee) must explain to each subject (or the 
subject’s legally authorized representative) in layman’s terms, the nature of the study, its 
purpose, expected duration, and the benefits and risks of study participation. Also, subjects 
will be informed of uses and disclosures of their medical information for research purposes 
and their rights to access information about them. The subjects must be informed of their 
rights to withdraw from the study at any time for any reason without sanction, penalty, or 
loss of benefits to which they are otherwise entitled, and that withdrawal from the study will 
not jeopardize their future medical care.  After this explanation and before entering the study, 
the subject (or legally authorized representative) must voluntarily sign and date the IRB-
approved ICF and HIPAA Consent Form in accordance with 21 CFR Parts 50 and 56. The 
subject will receive a copy of their ICF and HIPAA Consent Form.  
 
12.3.3 Confidentiality 
 
All information and data sent to Davol, Inc. or an authorized designee concerning subjects or 
their participation in the study will be considered confidential. All data used in the analysis 
and reporting of this study will be used in a manner without identifiable reference to the 
subject. The Investigator consents to visits by personnel of Davol, Inc. and its affiliates or 
designees, as well as, FDA representatives. 
 
12.4 Protocol Adherence and Deviations  
 
The study will be conducted as described in this protocol.  Investigators are not permitted to 
deviate from this protocol except to protect patient rights, safety or well-being.  Any 
deviations from this protocol must be documented by the Investigator.  If an emergency 
situation arises in which the rights, safety and well-being of a subject may require immediate 
alternative intervention, the Investigator should act in the best interest of the subject.  
Sponsor and the site’s IRB must be notified immediately if this occurs.  This should be 
followed with written confirmation that describes the emergency action and outcomes, to 
Sponsor and per IRB reporting requirements. Protocol deviations will be reviewed during 
routine monitoring visits. Investigators will be required to identify preventive and corrective 

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actions to prevent further deviations. An Investigator may be disqualified from the study for 
repeated and/or egregious protocol deviations. 
 
This protocol may be amended as necessary by the Sponsor. Any protocol amendments will 
be documented via an incremented version of this protocol (with relevant revision history) 
and a “was/is” comparison table to highlight the protocol changes. Amendments to the 
protocol must undergo the same approval process by the Sponsor, Investigators, IRBs and 
regulatory authorities as the original protocol. 
 
 
12.5 Device Accountability 
 
Only commercially available surgical mesh products will be used. Device accountability will 
not be required.  
 
12.6 Data Collection 
 
The Investigator is responsible for completely and accurately recording study data in the 
appropriate sections of the eCRFs provided by Sponsor.  The eCRFs must be signed by the 
Investigator or by his/her documented designee. 
 
The Investigator is also responsible for making source documents and forms readily available 
for a thorough review by the study monitor at each monitoring visit.  The monitor will ensure 
the accuracy of data recording at each investigational site by comparison to supporting 
source documents during periodic site visits.  Adherence to proper recording of information 
as well as assuring that corrections are being made will also be addressed during these 
periodic visits. 
 
12.7 Subject Compensation 
 
To compensate subjects for their time and participation, they may receive stipends upon 
completion of each of the protocol specified study visits.  If the subject does not complete a 
visit, they will not be compensated for that visit.   
 
12.8 Communications with the Sponsor 
 
Although the Investigator and his/her staff may have contact with other key individuals at the 
Sponsor throughout the course of the study, all communications regarding conduct of the 
study must be channeled through the Sponsor’s clinical affairs personnel or their designees. 
 
12.9 Required Documentation  
 

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An Investigator may not screen or enroll subjects until authorized to do so by the Sponsor.  
At a minimum, the following documentation must be received by the Sponsor prior to study 
commencement:  
 
 CVs and medical licenses for the principal Investigator and sub-Investigators;  
 Signed Clinical Study Agreement;  
 Signed Nondisclosure Agreement; 
 Signed “Protocol Signature Page” (page ii of this protocol);   
 Written approval from the IRB of both the protocol and ICF;   
 Signed Financial Disclosure Statement; and 
 IRB Assurance of Compliance Form or equivalent. 
 
13 SITE MONITORING 
 
The study monitors are designated as agents of the Sponsor and are assigned to oversee the 
conduct and progress of the study and to be the principal communication link between the 
Sponsor and the Investigator. 
 
The study monitors will be involved in Investigator selection and training, assurance of IRB 
approvals, and periodic on-site inspection and monitoring of sites and records, to ensure 
continued compliance with the protocol and adequacy of the Investigator and the facility to 
carry out the study. In addition, the monitor will verify that the device is being used in 
accordance with the protocol instructions. 
 
The site may also be subject to a quality assurance audit by personnel of the Sponsor as well 
as by FDA representatives. 
 
The monitor will perform several types of site visits during the course of the study. In all 
cases, the study monitor will provide a written summary of the visit, including necessary 
follow-up items, to the Investigator and Sponsor. 
 
It is important that the Investigator(s) and the relevant site personnel are available during the 
monitoring visits, and possible audit, and that sufficient time is devoted to the process. 
 
13.1 Study Initiation Visit 
 
Before the study begins, the study monitor will visit the site. The purpose of this visit is to 
review with the Investigator and staff the provisions and proper conduct of the clinical 
evaluation. This includes a detailed review of the protocol and eCRFs with instructions as to 
their completion, as well as reviewing regulations pertaining to the conduct of the clinical 
study. Arrangement for timely and accurate reporting of clinical data and relevant medical 
events will be established as well as ensuring safe and secure storage for the study devices. 
 
The study monitor will: 

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 Confirm that the ICF to be used is the one approved by the IRB; 
 Verify that all necessary documents are on file at the site; and 
 Confirm that there are provisions to continue and maintain all documents and records 
throughout the study as required by GCP regulations. 
 
 
 

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13.2 Ongoing Monitoring Visits 
 
The study monitor will maintain personal contact with the Investigator and staff throughout 
the study by telephone, e-mail, fax, mail, and on-site visits. On-site monitoring will begin 
after the first subjects are enrolled and continue until the study is completed. The monitoring 
will assure continued protocol compliance, adequate subject enrollment, accurate data 
reporting (including the comparison of eCRFs with subject records), device accountability (if 
required), and continued IRB acceptance of the study. The study monitor will evaluate and 
summarize the results of each visit in written reports, identifying any ongoing data problems 
with any study site and specifying recommendations for resolution of noted deficiencies. A 
formal monitoring plan will describe the planned extent of source data verification. 
 
13.3 Final Monitoring Visit  
 
At the completion of the study, the study monitor will conduct a final on-site visit. The 
purpose of this visit is to collect all outstanding study data documents, confirm that the 
Investigator’s files are accurate and complete, review the record retention requirements with 
the Investigator, provide the return of unused devices (if required) to the sponsor, review 
records which account for device shipment (if required), and assure that all applicable 
requirements for closure of the study are met. The actions and observations made at this visit 
will be recorded and filed. 
 
14 TERMINATION OF STUDY  
 
Sponsor reserves the right to suspend enrollment or terminate the study at any time as set 
forth in the Clinical Study Agreement.  Written notice will be submitted to the Investigator in 
advance of such termination. 
 
Sponsor may suspend enrollment or terminate the study at a specific site for reasons 
including, but not limited to, inadequate data collection, low subject enrollment rate, 
achievement of the total enrollment, or non-compliance with the protocol or other clinical 
research requirements. 
 
15 REPORTING REQUIREMENTS  
 
The Investigator must promptly report to Sponsor any withdrawal of IRB approval at the site.  
Additional reporting requirements of the Investigator include: 
 
 Reporting all ICF violations to the IRB 
 Reporting all device related AEs to Davol Field Assurance Department 
 
 
 
 

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16 RECORD RETENTION  
 
The investigator shall retain all study records for a period of 2 years after the investigation is 
terminated or completed, or until the records are no longer required as determined by the 
Sponsor.  The investigator may withdraw from the responsibility to maintain records for the 
period required and transfer custody of the records to any other person who will accept 
responsibility for retaining them with pre-approval.  Notice of a transfer shall be given to the 
Sponsor not later than 10 working days after transfer occurs. 

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17 REFERENCES 
 
1. Cobb W, Kercherk, Heniford B. Laproscopic repair of incisional hernias. The 
Surgical Clinics of North America 2005;85: 91 – 103. 
 
2. Mudge M, Hughes LE. Incisional hernia: a 10-year prospective study of incidence 
and attitudes. Br J Surg 1985;72: 70 – 71. 
 
3. Luijendijk R. Hop E, van den Tol M, et al. Comparison of surgical repair with mesh 
repair for incisional hernia. New Engl J Med 2000;343: 392 – 398. 
 
4. Anthony T, Bergen PC, Kim L, et al. Factors affecting recurrent following incisional 
herniorrhaphy. World J of Surg 2000;24: 95 – 101. 
 
5. Burger J, Luijendijk R, Hop W, et al. Long-term follow-up of a randomized 
controlled trial of suture versus mesh repair incisional hernia. Ann Surg 204;240: 578 
– 583. 
 
6. van Geffen H, Simmermacher R, van Vroonhoven T, van der Werken C. Surgical 
treatment of large contaminated abdominal wall defects. J Am Coll Surg 2005;201: 
206 – 212. 
 
7. George C, Ellis H. The results of incisional hernia: a twelve-year review. Ann R Coll 
Surg Engl 1986; 68:185-187. 
 
8. Ramirez RM, Ruas E, Dellon AL. “Components separation method for closure of 
abdominal-wall defects: An anatomic and clinical study. Plast Reconstruct Surg 1990; 
86:519 – 526. 
 
9. DiBello J, Moore J. Sliding myofascial flap of the rectus abdominis muscle for the 
closure of recurrent ventral hernias. Past Reconstr Surg 1996; 98:464 – 469. 
 
10. Girotto J, Ko M, Redett, et al. Closure of chronic abdominal wall defects: a long-term 
evaluation of the component separation method. Ann Plat Surg 1999; 42:385 – 395. 
 
11. Shestak K, Edington H, Johnson R. The separation of anatomical components 
technique for the reconstruction of massive midline abdominal wall defects: anatomy, 
surgical technique, application and limitations revisited. Plast Reconstr Surg 2000; 
105:731- 738. 
 
12. Lowe J, Garza J, Bowman J, et al. Endoscopically assisted “components separation 
technique” for closure of abdominal wall defects. Plat Reconstr Surg 2000; 105:720 – 
729. 
 

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13. Markar SR, Karthikesalingam A, Alam F, Tang TY, Walsh SR, Sadat U. Partially or 
completely absorbable versus nonabsorbable mesh repair for inguinal hernia: a 
systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech. 2010 
Aug; 20(4):213-9. Review. PubMed PMID: 20729687. 
 
14. Hakeem A, Shanmugam V.  Inguinodynia following Lichtenstein tension-free hernia 
repair: A review. World J Gastroenterol. 2011;17(14):1791-1796. 
 
15. Sadowski B, Rodriguez J, Symmonds R, Roberts J, Song J, Rajab MH, Cummings C, 
Hodges B; The Scott and White Outcomes and Effectiveness Registry Group.  
Comparison of polypropylene versus polyester mesh in the Lichtenstein hernia repair 
with respect to chronic pain and discomfort.  Hernia. Published online: 14 July 2011.  
Doi: 10.1007/s10029-011-0841-x.  
 
16. Martin DP, Williams SF.  Medical applications of poly-4-hydroxybutyrate: a strong 
flexible absorbable biomaterial.  Biochemical Engineering Journal 2003;16:97-105.  
 
17. Chen GQ, Wu Q. The application of polyhydroxyalkanoates as tissue engineering 
materials. Biomaterials. 2005 Nov26;33:6565-78.  
 
18. Wu Q, Wang Y, Chen GQ.  Medical application of Microbial Biopolyesters 
Polyhydroxyalkanoates.  Artificial Cells, Blood Substitutes, and Biotechnology 
2009;37:1-12. 
 
19. Martin DP, Badhwar A, Shah DV, Rizk S, Eldridge SN, Gagne DH, Ganatra A, 
Darois RE, Williams SF, Tai HC, Scott JR. Characterization of poly-4-
hydroxybutyrate mesh for hernia repair applications. Journal of Surgical Research. 
2013 Apr 2; Epub ahead of print. 
 
20. Deeken C, Matthews BD. Characterization of the Mechanical Strength, Resorption 
Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-
Hydroxybutyrate – PHASIXTM Mesh) in a Porcine Model of Hernia Repair. ISRN 
Surgery. 2013 Apr 23;2013:1-12.    
 
21. Data on file. Warwick, RI, USA: Davol Inc., RPT3803626, Rev 0.  
 
22. Albertsmeier M, Seiler CM, Fischer L, Baumann P, Husing J, Seidlmayer C., Franck 
A, Jauch KW, Knaebel HP, Buchler MW. Evaluation of the safety and efficacy of 
MomoMax suture material for abdominal wall closure after primary midline 
laparotomy – a controlled prospective multicenter trial. Langenbecks Arch Surg. 
2012 Mar; 397(3):363-71) 
 
23. Morris PJ, Malt RA.  Oxford textbook of Surgery Volume 1.  Oxford:  Oxford 
Medical Publications, Oxford University Press, 1994. 
 

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24. Mangram AA, Horan TC, Peron ML, Silver LC, Jarvis WR. Guidance for prevention 
of surgical site infection, 1999. Infection Control and Hospital Epidemiology. 1999; 
20 (4):247 – 278. 
 
25. CDC Surgical Site Infection (SSI) Event Protocol 
http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf 
  
 
 
 

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18 APPENDICES 
 
Appendix 1: Principal Investigator Information 
John Scott Roth, MD 
University of Kentucky Medical Center 
800 Rose Street, #C222 
Lexington, Kentucky 40536 
Phone: 859-323-6346 ext. 232 
 
 
 
 

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Appendix 2: Phasix™ Mesh Instructions for Use
 

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Appendix 3: Surgical Site Infection Classification24  
Superficial Incisional Surgical Site Infections (SSI) 
Infection occurs within 30 days after the operation and 
Infection involves only the skin or subcutaneous tissue around the incision and at least one of 
the following: 
1. Purulent drainage with or without laboratory confirmation, from the superficial 
incision. 
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the 
superficial incision. 
3. At least one of the following signs or symptoms of infection: pain or tenderness, 
localized swelling, redness or heat and superficial incision is deliberately opened 
by a surgeon, unless the culture is negative. 
4. Diagnosis of superficial incisional SSI by the surgeon or attending physician. 
 
NOTE: Do not report the following as SSI: 
1. Stitch abscesses (minimal inflammation and discharge confined to the points of 
suture penetration) 
2. Infection of the episiotomy or neonatal circumcision sites 
3. Infected burn wound. 
4. Incisional SSI that extends into the fascial and muscle layers (see definition for 
Deep Incisional Surgical Site Infections below).  
 
Note: Specific criteria are used for identifying infected episiotomy and circumcision sites and 
burn wounds. 
 
Deep Incisional SSI 
Infection occurs within 30 days after the operation if no implant is left in place or within one 
year if implant is in place and the infection appears to be related to the operation. 
and 
Infection involves deep soft tissues (e.g., fascia and muscle layers) of the incision and at least 
one of the following: 
1. Purulent drainage from the deep incision but not from the organ/space of the 
surgical site. 
2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon 
when the patient has at least one of the following signs: fever (>38°C), localized 
pain or tenderness unless the culture is negative. 
3. An abscess or other evidence of infection involving the deep incision is found on 
direct examination, during reoperation, or by histopathologic or radiologic 
examination. 
4. Diagnosis of a deep SSI by a surgeon or attending physician.    
 
Notes: 
1. Report infection that involves both superficial and deep incision as deep incisional 
SSI. 
2. Report an organ / space SSI that drains through the incision as deep incisional SSI. 
Appendix 4: Surgical Wound Classification25 

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 Class I/Clean: An uninfected operative wound in which no inflammation is 
encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not 
entered. In addition, clean wounds are primarily closed and, if necessary, drained with 
closed drainage. Operative incisional wounds that follow nonpenetrating (blunt) 
trauma should be included in this category if they meet the criteria. 
 
 Class II/Clean-Contaminated*: An operative wound in which the respiratory, 
alimentary, genital, or urinary tracts are entered under controlled conditions and 
without unusual contamination. Specifically, operations involving the biliary tract, 
appendix, vagina, and oropharynx are included in this category, provided no evidence 
of infection or major break in technique is encountered. 
 
 Class III/Contaminated*: Open, fresh, accidental wounds. In addition, operations with 
major breaks in sterile technique (e.g., open cardiac massage) or gross spillage from 
the gastrointestinal tract, and incisions in which acute, non-purulent inflammation is 
encountered including necrotic tissue without evidence of purulent drainage (e.g. 
dry gangrene) are included in this category. 
 
 Class IV/Dirty-Infected*: Old traumatic wounds with retained devitalized tissue and 
those that involve existing clinical infection or perforated viscera. This definition 
suggests that the organisms causing postoperative infection were present in the 
operative field before the operation. 
 
* NOTE: In this study, subjects with Class II, Class III and Class IV wounds are to be 
excluded from enrollment.