A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair
Phase: NA
Conditions: Hernia, Ventral, Incisional Hernia
Sponsor: C. R. Bard

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CLINICAL STUDY PROTOCOL 
 
 
Title:                            
ATLAS (A prospective, multi-center Trial of a Long-term 
bio-Absorbable mesh with Sepra technology in challenging 
laparoscopic ventral or incisional hernia repair) 
 
Protocol Number:   
DVL-HE-017 
 
Study Type: 
Post-market, multi-center, prospective, single-arm, open 
label 
 
Date: 
April 16, 2018 
 
Version: 
5.0 
 
Study Devices: 
Phasix™ ST 
 
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 
 
 
 
BD Global Clinical Development 
Telephone: 908-277-8082 
E-mail: 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 
A1C 
Glycated hemoglobin 
AE 
Adverse event 
Bard 
C. R. Bard, Inc. 
BMI 
Body Mass Index 
°C 
Degrees in Celsius 
CBGB 
Coronary Artery Bypass Graft Procedures 
CDC 
US Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
cm 
Centimeter 
CMC 
Carboxymethylcellulose 
COPD 
Chronic Obstructive Pulmonary Disease 
C-section 
Cesarean Section 
CST 
Component Separation Technique 
CT 
Computed Tomography Scan 
CV 
Curriculum vitae 
DIP 
Deep Incisional Primary 
DIS 
Deep Incisional Secondary 
doi 
Digital object identifier 
eCRF 
Electronic Case Report Form 
e.g. 
For Example 
ET 
Early Termination 
et al. 
Et alia (and others) 
etc. 
Et cetera 
FDA 
Food and Drug Administration 
FPG 
Fasting Plasma Glucose 
GCP 
Good Clinical Practice 
g/dL 
Grams per deciliter 
HA 
Hyaluronate 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
i.e. 
That Is 
IFU 
Instructions For Use 
Inc. 
Incorporated 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
kg/m2 
Kilograms per meter squared 
LTFU 
Lost to Follow-Up 
mg/dL 
Milligrams per deciliter 
mITT 
Modified Intent to Treat 
ml 
Milliliter 
mm 
Millimeter 

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MRI 
Magnetic Resonance Imaging 
OGTT 
Oral Glucose Tolerance Test 
OTC 
Over-the-counter 
P4HB 
Poly-4-hydroxybutyrate 
PDS 
Polydioxanone 
PEG 
Polyethylene glycol 
PGA 
Polyglycolic acid 
PP 
Per-Protocol 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SF-12® 
12-Item Short Form 
SIP 
Superficial Incisional Primary 
SIS 
Superficial Incisional Secondary 
SSI 
Surgical Site Infection 
SSO 
Surgical Site Occurrence 
ST 
Sepra® Technology 
TM 
Trademark 
US 
United States 
VAS 
Visual Analogue Scale 
WOCBP 
Women of Childbearing Potential  
 

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TABLE OF CONTENTS 
 
1 
INTRODUCTION .................................................................................................. 8 
1.1 
Background ............................................................................................................. 8 
1.2 
Rationale ................................................................................................................ 10 
1.3 
Device Descriptions ............................................................................................... 10 
1.3.1 
Phasix™ ST .......................................................................................................... 10 
2 
STUDY OBJECTIVES......................................................................................... 11 
3 
STUDY ENDPOINTS ........................................................................................... 12 
3.2 
Secondary Endpoints ............................................................................................ 12 
4 
STUDY DESIGN ................................................................................................... 12 
5 
STUDY POPULATION ....................................................................................... 12 
5.1 
Number of Subjects .............................................................................................. 12 
5.2 
Eligibility Criteria ................................................................................................. 13 
5.2.1 
Inclusion Criteria ................................................................................................ 13 
5.2.2 
Exclusion Criteria ............................................................................................... 13 
6 
STUDY PROCEDURES ...................................................................................... 14 
6.1 
Subject Screening and Baseline Evaluation ....................................................... 14 
6.1.1 
Informed Consent................................................................................................ 15 
6.1.2 
Enrollment........................................................................................................... 15 
6.1.3 
Eligibility ............................................................................................................ 15 
6.1.4 
Evaluation of Pregnancy Status .......................................................................... 15 
6.1.5 
Assignment of Subject Screening Number ......................................................... 16 
6.1.6 
Blinding............................................................................................................... 16 
6.1.7 
Demographics and Medical History ................................................................... 16 
6.1.8 
Physical Examination.......................................................................................... 16 
6.1.9 
Concomitant Pain Medication Usage.................................................................. 16 
6.1.10 
Patient Reported Outcome Assessments ......................................................... 16 
6.2 
Surgical Procedure ............................................................................................... 16 
6.2.1 
General Procedures ............................................................................................. 16 
6.2.2 
Postoperative Care .............................................................................................. 17 
6.2.3 
Surgical Details ................................................................................................... 17 

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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 ........................................................................................................ 18 
6.3.4 
Unscheduled Visits ............................................................................................. 18 
6.4 
TABLE OF STUDY EVENTS ............................................................................. 20 
6.5 
Withdrawal and/or Early Termination .............................................................. 21 
7 
STATISTICAL METHODS ................................................................................ 21 
7.1 
Study Hypothesis................................................................................................... 21 
7.2 
Sample Size Considerations ................................................................................. 22 
7.3 
Data Analysis ......................................................................................................... 22 
8 
ADVERSE EVENTS ............................................................................................ 22 
8.1 
Definition of Adverse Events ............................................................................... 23 
8.2 
Definition of Serious Adverse Events .................................................................. 23 
8.3 
Relationship of Adverse Event to Device/Procedure ......................................... 23 
8.4 
Severity of Adverse Events ................................................................................... 24 
8.5 
Reporting Of Adverse Events .............................................................................. 24 
9 
MECHANICAL FAILURES, MALFUNCTIONS AND DEFECTS ............... 25 
10 
CASE REPORT FORMS ..................................................................................... 25 
11 
RISK/BENEFIT ANALYSIS ............................................................................... 25 
12 
ADMINISTRATIVE REQUIREMENTS ........................................................... 26 
12.1 
Publication Policy ................................................................................................. 26 
12.2 
Investigator Selection ........................................................................................... 26 
12.3 
Regulatory and Ethical Considerations .............................................................. 26 
12.3.1 
Institutional Review Board Approval ............................................................. 26 
12.3.2 
Informed Consent and HIPAA Authorization ................................................ 27 
12.3.3 
Confidentiality ................................................................................................ 27 
12.4 
Protocol Adherence and Deviations .................................................................... 27 
12.5 
Device Accountability ........................................................................................... 28 
12.6 
Data Collection ...................................................................................................... 28 
12.7 
Subject Compensation .......................................................................................... 28 
12.8 
Communications with the Sponsor ..................................................................... 28 

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12.9 
Required Documentation ..................................................................................... 28 
13 
SITE MONITORING ........................................................................................... 29 
13.1 
Study Initiation Visit ............................................................................................ 29 
13.2 
Ongoing Monitoring Visits ................................................................................... 30 
13.3 
Final Monitoring Visit .......................................................................................... 30 
14 
TERMINATION OF STUDY .............................................................................. 30 
15 
REPORTING REQUIREMENTS ...................................................................... 30 
16 
RECORD RETENTION ...................................................................................... 31 
17 
REFERENCES ...................................................................................................... 32 
18 
APPENDICES ....................................................................................................... 35 
 
 

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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 348,000 
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 Use of synthetic mesh reduces hernia 
recurrence rates, although its use has been associated with complications such as infection, 
adhesions, fistulae, and foreign body reactions including increased inflammation and/or 
connective tissue deposition.8 
 
Synthetic mesh repair procedures, either open or laparoscopic, have been reported to lead to 
fewer recurrences compared to primary repairs.9, 10, 11  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.12  These large abdominal wall defects have been associated with recurrence 
rates of up to 46%.13 
 
Laparoscopic ventral hernia repair was ﬁrst reported by LeBlanc in 1992, and is popular 
alternative to open repairs due to the potential benefit of shorter hospital stays, improved 
patient outcomes, and fewer complications compared to open repairs.14, 15  In a large series 
(850 patients) by Heniford, et al., laparoscopic ventral hernia repair using prosthetic mesh 
had a low rate of conversion to open surgery (3.4%),  length of hospital stay (2.3 days), a 
moderate complication rate (13.2%), and a low hernia recurrence rate of 4.7% (average 
follow-up of 20 months).15  In a study by Orenstein, et al., laparoscopic ventral hernia repair 
with defect closure had a low recurrence rate (none in 47 consecutive patients out to 16.2 
months follow-up).16  They purported that defect closure eliminated postoperative seromas 
and patient reports of bulging and reduced the size of implanted mesh.16 
 
Ideally, a resorbable 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-
resorbable mesh material.  However, the development of resorbable mesh products has faced 

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challenges related to the rate of resorption with complications arising when the mesh product 
is resorbed too quickly.  Rapid resorption does not support sufficient healing if structural 
reinforcement is diminished during the tissue repair period.  A resorbable mesh should 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.17,18,19  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. 21, 22  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 hernia repair study demonstrated that Phasix™ Mesh could perform as a durable 
scaffold for soft tissue repair.21 The results of the 52-week study showed that the repair site 
had significantly greater mechanical repair strength, as compared to native abdominal wall. 
Notably, repair strength persisted even after significant Phasix™ Mesh resorption (as 
measured by molecular weight).  Histologically, 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 
other fully-resorbable competitive meshes had a greater overall host inflammatory response, 
whereas the response to Phasix™ Mesh was relative comparable to permanent polypropylene 
mesh.22 In the same study, histological analyses demonstrated similar variability on measures 
of host fibrotic response. 
 
The subject of this study, Phasix™ ST is a fully resorbable mesh with a hydrogel coating that 
is also resorbable. It is a sterile mesh device with indication for use in the reinforcement of 
soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the 
repair of hernias. Phasix™ ST Mesh is comprised of a co-knitted mesh and hydrogel coating.   
 
The fascial side of the mesh allows for a prompt fibroblastic response through the interstices 
of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone. The 
visceral side of the mesh is coated with a resorbable, chemically modified sodium 
hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based 
hydrogel. The resorbable hydrogel coating functions to separate the mesh from underlying 
tissues and organ surfaces to help minimize tissue attachment to the mesh. Shortly after 
hydration in saline, the biopolymer coating becomes a hydrated gel that is resorbed from the 
site in less than 30-days.  See Section 1.3 Device Description, for more information. 

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A laparoscopic, porcine study was conducted to evaluate peritoneal tissue attachment 
development 4 weeks after implantation of Phasix™ ST Mesh or Ventralight ™ ST Mesh 
(each group used 4 pigs; 8 meshes).  At 4 weeks post-implantation, there were very few 
instances of light, omental tissue attachments in both groups.  The overall tissue attachment 
scores associated with Phasix™ ST Mesh was not significantly different than for 
Ventralight™ ST Mesh.   These results indicate that the hydrogel barrier (Sepra® 
Technology) properties associated with Ventralight™ ST Mesh are maintained with 
Phasix™ ST Mesh.22 
 
Additional porcine studies were conducted to characterize the strength of a buttress repair 
over time.  Twenty-four, female, Yucatan pigs were implanted bilaterally with mesh 
according to one of the following: a) underlay repair with Phasix™ ST Mesh; b) underlay 
repair with Ventralight™ ST Mesh; c) a retromuscular repair with Phasix™ Mesh or d) a 
retromuscular repair with Strattice™ Firm Reconstructive Matrix.  Bilateral surgical defects 
(1” diameter) were created and subsequently repaired with PDS suture.  Mesh devices were 
placed and fixated with absorbable tacks or sutures.  Ball burst strength and host responses 
were measured at mesh placement and 12- or 24-weeks post-implantation.22   
 
At 12- or 24-weeks, the burst strength of the Phasix™ ST Mesh repair was at, or slightly 
above, the burst strength at the time of mesh placement (despite the hydrolysis of the 
Phasix™ material over these time periods).   This suggests a transfer of load from the 
degrading Phasix™ material to the newly ingrown host tissue.  The Strattice™ Firm 
Reconstructive Matrix repairs showed a significant reduction in strength of the repair site at 
12- or 24-weeks and they had significantly lower burst strength relative to Phasix™ and 
Phasix™ ST Mesh devices.  At 12- or 24-weeks, histology demonstrated that a robust and 
biocompatible ingrowth is associated with the Phasix™ material.  Neovascularization occurs 
more rapidly in the Phasix™ material relative to the Strattice™ Firm Reconstructive 
Matrix.22   
 
This post-approval clinical study is being conducted to evaluate the use of Phasix™ ST Mesh 
in laparoscopic ventral or incisional hernia repair in patients with a higher level of risk for 
Surgical Site Occurrence (SSO) as defined by the presence of 1 or more comorbid 
conditions.  Patients who receive a Phasix™ ST implant will be followed for 24-months. 
 
1.2 
Rationale 
 
This study is intended to evaluate the use of Phasix™ ST for laparoscopic ventral or 
incisional hernia repair amongst subjects at high risk for SSO. 
 
1.3 
Device Descriptions 
 
1.3.1 Phasix™ ST  
 

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Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.  It is a 
sterile mesh device with indication for use in the reinforcement of soft tissue, where 
weakness exists, in procedures involving soft tissue repair, such as for the repair of hernias. 
Phasix™ ST Mesh is comprised of a co-knitted mesh and hydrogel coating.   
 
Preclinical implantation studies indicate that resorption of the P4HB fibers is minimal 
throughout the 12 week expected healing period, and remains minimal up to 26-weeks post 
implantation.  Significant degradation of the mesh fibers observed in preclinical studies 
within 12- to 18-months indicates loss in mechanical integrity and strength of the mesh. 
While fiber segments were observed at 18-months, they continued to degrade.20, 21  
 
The fascial side of the mesh allows for a prompt fibroblastic response through the interstices 
of the mesh, allowing for complete tissue ingrowth, similar to P4HB mesh alone.  The 
visceral side of the mesh is coated with a resorbable, chemically modified sodium 
hyaluronate (HA), carboxymethylcellulose (CMC), and polyethylene glycol (PEG) based 
hydrogel.  The resorbable hydrogel coating functions to separate the mesh from underlying 
tissues and organ surfaces to help minimize tissue attachment to the mesh.  Shortly after 
hydration in saline, the biopolymer coating becomes a hydrated gel that is resorbed from the 
site in less than 30-days. 
 
Phasix™ ST Mesh and Phasix™ Mesh are similar in material; with both containing P4HB, the 
largest percentage of material present in Phasix™ ST Mesh.  The difference between the 
meshes is that Phasix™ Mesh does not have polyglycolic acid (PGA) fibers or a hydrogel 
coating.  
 
Phasix™ ST Mesh was designed to handle similarly to polypropylene (permanent) mesh at 
implantation, but it is fully resorbable.  It is expected to maintain its strength over the critical 
healing period; minimize tissue attachment to the mesh, and resorbs, leaving no foreign 
material behind. 
 
Phasix™ ST is commercially available in the US and indicated for use in the reinforcement 
of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for 
the repair of hernias.  Because Phasix™ ST 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™ ST is included in the product’s Instructions for Use (IFU). 
 
2 
STUDY OBJECTIVES  
 
The objective of this study is to collect additional data on safety, performance and 
effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia 
repair at high risk for SSO.  Subjects at high risk are defined as having 1 or more of the 
following co-morbid 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 

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serum albumin, advanced age, or renal insufficiency.  The study end points are described 
below. 
 
3 
STUDY ENDPOINTS 
 
There is one primary endpoint, SSO, and eight secondary endpoints: 
 
3.1 Primary Endpoint 
 
1. Surgical Site Occurrence (defined as and of the following complications requiring 
intervention: surgical site infection (see Appendix 2 for definitions), seroma, 
hematoma, wound dehiscence, skin necrosis, mesh infection and fistulas) within 
45-days post-implantation. 
 
3.2 
Secondary Endpoints 
 
1. Surgical Site Occurrence (defined as surgical site infection (see Appendix 2 
for definitions), seroma, hematoma, wound dehiscence, skin necrosis, mesh 
infection and fistulas requiring intervention) > 45-days post-implantation 
2. Hernia Recurrence Rate will be assessed by physical examination at each 
study visit through 24-months.  A recurrent hernia will be defined as any 
hernia identified or confirmed by the investigator, during any study follow-up 
visit, within 5 cm of the hernia repaired in the study procedure.   
3. Surgical Pain Scale - Visual Analog Scale (VAS)  
4. Device related adverse event incidence 
5. Rate of reoperation due to the index hernia repair 
6. Quality of life assessments (Carolinas Comfort Scale® and SF-12®) 
7. Surgical procedure time as measured from incision to closure (skin to skin) 
8. Length of stay 
 
4 
STUDY DESIGN 
 
This is a prospective, multi-center, single-arm, open-label study designed to collect 
additional data on the safety, performance and effectiveness of Phasix™ ST for laparoscopic 
ventral or incisional hernia repair.  Follow-up visits will be conducted at 1, 3, 6, 12, 18, and 
24-months following surgery.  See Section 6 for a detailed schedule of study visits and 
procedures.   
5 
STUDY POPULATION 
 
5.1 
Number of Subjects 
 
This study is projected to treat approximately 120 subjects at approximately 16 US sites. 
 

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5.2 
Eligibility Criteria 
 
5.2.1 Inclusion Criteria 
 
The subject must meet all of the criteria listed below to be treated in the study: 
1. Subject must be 18 years of age or older 
2. Subject must be willing to give written informed consent 
3. Subject must be diagnosed with ventral or abdominal incisional hernia 
4. Subject must be willing to undergo laparoscopic hernia repair using intraabdominal 
placement (with or without Component Separation Technique (CST)) 
5. Surgeon must be able to fully close the hernia defect.  Defect closure is defined as 
complete re-approximation of fascial edges, leaving no gap.  Since the safety and 
effectiveness of Phasix™ ST Mesh in bridging repairs has not been evaluated or 
established, the defect should be closed prior to mesh use. 
6. Subject is expected to meet the criteria for a Class I wound as defined by the CDC 
(Appendix 3) 
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 smoker (including 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 (if yes, diagnosis to be confirmed via medical records or 
laboratory results according to 2014 Joslin Clinical Guideline for Adults with 
Diabetes)(Appendix 5)  
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 treatment in the study if any of the following criteria are 
met: 
 
1. Subject has had 4 or more previous hernia repairs (of the index hernia) 
2. Subject’s hernia is > 350 cm2 
3. Complete removal of existing mesh from a prior hernia repair (in the same affected 
area) is not possible 
4. Subject has intact permanent mesh adjacent to the current hernia to be repaired 
5. Preperitoneal placement of mesh 
6. The subject is known to have a collagen disorder 
7. The subject has peritonitis 

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8. The subject is on or suspected to be placed on chemotherapy medications during any 
part of the study 
9. The subject’s Body Mass Index (BMI) is > 40 kg/m2 
10. The subject has cirrhosis of the liver and/or ascites 
11. Subject is American Society of Anesthesiology Class 4 or 5 
12. Subject has a life expectancy of less than 2 years at the time of enrollment 
13. 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 
14. 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 
3) 
15. Subject has an active or latent systemic infection 
16. Patient has a contraindication to placement of mesh  
17. Subject requires surgical bridge repair as the sole repair  
18. Subject is pregnant or has plans to become pregnant during the study period 
19. Subject has enrolled in another interventional clinical study within the last 30 days 
20. Subject is part of the site personnel directly involved with this study 
21. 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). 
 
6 
STUDY PROCEDURES 
 
6.1 
Subject Screening and Baseline Evaluation 
 
Subjects with a diagnosis of ventral or abdominal incisional hernia receiving laparoscopic 
surgical repair (including robotic-assisted repairs) with defect closure, will be screened for 
potential eligibility against the study protocol inclusion and exclusion criteria, utilizing 
ordinary standard of care procedures (e.g., physical examination, blood work, medical 
evaluation) within 60 days of the date of consent.  Since the safety and effectiveness of 
Phasix™ ST Mesh in bridging repairs has not been evaluated or established, the defect 
should be closed prior to mesh use.  This may include a full anesthetic work-up customary 
for hernia repair procedures.  Any other standard of care examination or evaluation within 60 
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. 

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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 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 study 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) 
that occur prior to the surgical procedure will be added to the medical history.  Any adverse 
event that occurs from the beginning of the surgical procedure until the subject is determined 
as screen failure will be recorded on the AE eCRF.  
 
6.1.4 Evaluation of Pregnancy Status 
 
The pregnancy status of potential study subjects will be evaluated as part of the 
screening assessment as follows: 
 
Women of child bearing potential (WOCBP) must undergo a pregnancy test (urine or 
blood).  A negative pregnancy test (urine or blood) must be obtained within 7 days of 
the surgical procedure.  
 
Women who are postmenopausal or not of child bearing potential (e.g. status post 
hysterectomy or tubal ligation, no menses in the past 12 months): status must be 
recorded to note that the subject is not of child bearing potential. 

Davol Inc. 
 
Final 5.0 
Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
CONFIDENTIAL 
Page 16 of 42 
 
6.1.5 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.). 
 
6.1.6 Blinding 
 
The study is an open-label study with a single treatment condition.  Subjects, investigator 
(and surgeon) will not be blinded to the study treatment.  
 
6.1.7 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.   
 
6.1.8 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.  
 
6.1.9 Concomitant Pain Medication Usage 
 
All pain medication taken within 24 hours of each study visit will be recorded in the source 
documentation at baseline and at each follow-up visit.  A designation of narcotic and non-
narcotic pain mediation will be recorded in the eCRF.  
 
6.1.10 Patient Reported Outcome Assessments 
 
Subjects will complete the Surgical Pain Scale -VAS, Carolinas Comfort Scale® and SF-12® 
to measure pain, discomfort and quality of life.   
 
6.2 
Surgical Procedure 
 
6.2.1 General Procedures 
 
All subjects will undergo laparoscopic ventral hernia repair.  Subjects will be administered 
pre-operative antibiotics according to hospital protocol.  There is an intraoperative exclusion 
for hernias >350 cm2.  All other intraoperative exclusion criterion should be verified (e.g., a 

Davol Inc. 
 
Final 5.0 
Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
CONFIDENTIAL 
Page 17 of 42 
 
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) as final eligibility is determined intraoperatively.   
 
The surgical technique will require intraabdominal (using absorbable sutures or tacks) mesh 
placement (with or without CST).  Ensure proper orientation (see IFU for details); the coated 
side of the prosthesis should be oriented against the bowel or sensitive organs.  Do not place 
the uncoated mesh side against the bowel.  There is a risk for adhesion formation or erosions 
when the uncoated mesh side is placed in direct contact with the bowel or viscera.  
 
The Phasix™ ST Mesh can be tailored without fraying or unraveling and offers bi-directional 
elasticity to adapt to various stresses encountered in the body.  Use a sharp surgical 
instrument (scissors) to trim the mesh.  To minimize chance of recurrence, trim the mesh 
such that it is large enough to provide sufﬁcient overlap beyond the margins of the defect.  If 
the material is cut too small, tension may be placed on the suture line, which may result in a 
recurrence of the original defect. 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 every 1 to 2 cm intervals.  The edges are then fixated to assure proper closure 
under correct tension.  
 
If a prior hernia repair utilizing mesh is in the same area to be treated for the study, complete 
removal of existing mesh is required for the subject to remain eligible for the study.  Subjects 
with intact permanent mesh adjacent to the study hernia to be repaired are excluded from the 
study.  Once all of the dissection is performed and all of the hernia has been exposed, the 
largest vertical and transverse dimensions should be recorded. 
 
The procedure may include CST to obtain site closure.  All skin incisions will be closed with 
staples and/or sutures and wounds will be dressed with sterile occlusive dressings. 
 
6.2.2 Postoperative Care  
 
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 according 
to the instructions in Appendix 4 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.   
 
6.2.3 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, 
concomitant procedures, procedure related complications and AEs.   
 
6.3 
Subject Follow-up 

Davol Inc. 
 
Final 5.0 
Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
CONFIDENTIAL 
Page 18 of 42 
 
6.3.1 Subjects Not Implanted and Surgical Repair Failures 
 
Subjects who are screened but do not have the study device placed should be considered 
screen failures 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 6.2.2 must be recorded in the source documentation.  
 
6.3.2 Subjects Successfully Implanted 
 
Subjects successfully implanted with Phasix™ ST will be followed as per the protocol 
defined follow-up procedures (see Table of Study Events).  
 
6.3.3 Assessments 
 
Subjects should report to their respective study site for follow-up visits at the following 
postoperative times: 
 Pregnancy test for WOCBP within 7 days of index surgery 
 1 month:    
Day 30 + 7 days  
 3 month:    
Day 90 + 30 days  
 6 month:    
Day 180 + 30 days  
 12 month:  
Day 365 + 60 days  
 18 month:  
Day 545 + 60 days  
 24 month:  
Day 730 + 60 days  
 
At each study visit, the following procedures will be completed and these data recorded in 
source documentation and on the eCRF:  
 
 Surgical Pain Scale -VAS  
 Carolinas Comfort Scale® 
 SF-12®  
 Physical exam to check for hernia recurrence and surgical complications. 
A recurrent hernia will be defined as any hernia identified or confirmed by the 
investigator, during any study follow-up visit, within 5 cm of the hernia repaired in 
the study procedure.  Note: If the subject undergoes imaging for any reason and a 
recurrent hernia is identified, it must be recorded. 
 Concomitant pain medication usage (all pain medication will be captured at baseline 
and all follow-up visits. 
 Assessment of AEs/complications 
 
6.3.4 Unscheduled Visits 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
CONFIDENTIAL 
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If the subject has an evaluation related to the abdomen or abdominal organs at any time 
during the study follow-up period, the subject will undergo unscheduled visit study 
procedures (see Table of Study Events).  
 
 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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6.4 
TABLE OF STUDY EVENTS 
Study Procedure 
Screening 
and 
Baseline 
Period 
 
Baseline  
Surgery 
1 Month 
Visit 
3 Month 
Visit 
6 Month 
Visit 
12 Month 
Visit 
18 Month 
Visit 
24 Month 
Visit 
Unscheduled 
Visit/Early 
Termination 
Visit Window (days) 
Within 60 
days of 
consent 
Within 7 
days of 
surgery  
0 
30 + 7 
90 + 30 
180 + 30 
365 + 60 
545 + 60 
730 + 60 
-- 
Describe study to 
potential subject 
X 
 
 
 
 
 
 
 
 
 
Obtain informed consent 
X 
 
 
 
 
 
 
 
 
 
Verify eligibility criteria 
X 
 
X1 
 
 
 
 
 
 
 
Pregnancy Test for 
WOCBP3 (urine or serum) 
 
X 
 
 
 
 
 
 
 
 
Collect demographics and 
medical history 
X 
 
 
 
 
 
 
 
 
 
Conduct physical 
examination 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Placement 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 
Collect pain medication 
usage 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Schedule next follow-up 
visit 
X 
 
X 
X 
X 
X 
X 
X 
 
 
1 Verification of eligibility against inclusion/exclusion criteria prior to device placement 
2 See Section 6.2 for surgical procedure details 
3WOCBP- Women of Childbearing Potential  

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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Page 21 of 42 
 
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.   
 
Additionally, subjects may be discontinued for reasons including, but not limited to the 
following: 
 Consent is withdrawn 
 Lost to follow-up (LTFU) 
 Investigator withdrawal of subject 
 Other  
 
A subject is considered LTFU 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 study device.  The site should attempt to bring the subject back to complete all 
ET visit study procedures (see Table of Study Events).   
 
A subject who receives a re-operation due to hernia recurrence or has the repair site 
surgically impacted in any way, may be withdrawn from the study upon discharge from the 
most recent hospitalization.  Site personnel will be responsible for documenting adverse 
events and other post-procedural complications on the applicable eCRF that the subject may 
have encountered during the hospitalization and up to 30 days post re-operation. 
 
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™ ST for hernia repair in 
order to assess SSO. 
 
 
 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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Page 22 of 42 
 
7.2 
Sample Size Considerations 
 
This study is projected to treat approximately 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 endpoint of SSO within 45 days post-implantation will be reported by visit 
along with the 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 SSO > 45 days post-implantation, hernia recurrence rate, pain – 
VAS, device related adverse event incidence, rate of reoperation due to the index hernia 
repair, Quality of life assessments (Surgical Pain Scale -VAS, Carolinas Comfort Scale® and 
SF-12®), surgical procedure time as measured from incision to closure (skin to skin) and 
length of stay 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™ ST implanted will have their AEs summarized separately 
and their outcome data will not be collected or analyzed.  
 
Exploratory analyses on subpopulations may be performed.  Interim analyses may be 
conducted during the study for data review purpose. 
 
 
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 

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Phasix™ ST 
 
 
April 16, 2018 
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during the study should be treated with established standards of care that will protect the life 
and health of the study subjects.   
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.  AEs that occur prior to the surgical 
procedure will be added to the medical history.  AEs that occur from the time of surgical 
procedure will be recorded in the source documentation and on the AE page of the eCRF 
 
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™ ST) or surgical procedures as 
follows: 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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 Device: This category should be restricted to AEs directly attributable to devices used 
as part of the study procedure. 
 
 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-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 
Davol Study Team within 24 hours of becoming aware of the event.  
 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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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 a Sponsor 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 considered to be possibly device related, and not 
procedure related or an issue of patient mismanagement (e.g., mesh used was too small to 
adequately cover the defect, too much tension, etc.), as determined by the Investigator. 
 
All mechanical failures, malfunctions, missing components, or any other defect of the study 
device or any components of the device kit that do not perform to specifications must be 
promptly reported to Davol:  
 
Field Assurance Department 
E-mail: Davol.FieldAssurance@crbard.com 
 
The event must also be documented on the Device Failure eCRF and the malfunctioning 
device should be retained for return and evaluation to Davol Field Assurance.   
 
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 
health, safety, or welfare of the subject.  The risks associated with hernia repair and Phasix™ 
ST may include, but are not limited to, seroma, adhesion, hematoma, pain, infection, 
inflammation, allergic reaction, hemorrhage, extrusion, erosion, migration, fistula formation 
and recurrence of the hernia or soft tissue defect. 
 

Davol Inc. 
 
Final 5.0 
Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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Page 26 of 42 
 
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 
 
12.3.1 Institutional Review Board Approval  
 

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Phasix™ ST 
 
 
April 16, 2018 
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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 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 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 
actions to prevent further deviations.  An Investigator may be disqualified from the study for 
repeated and/or egregious protocol deviations. 
 

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Phasix™ ST 
 
 
April 16, 2018 
Protocol DVL-HE-017 
 
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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 Phasix™ ST mesh 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  
 
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;  

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April 16, 2018 
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 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: 
 
 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 
 Reporting all SAE to the Davol Clinical Team 
 
 
 
 

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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 WS, Kercher KW, Heniford BT. Laparoscopic repair of incisional hernias. The 
Surgical Clinics of North America.  2005 Feb; 85(1): 91 – 103, ix. 
 
2. Mudge M, Hughes LE. Incisional hernia: a 10-year prospective study of incidence 
and attitudes. Br J Surg. 1985; 72: 70 – 71. 
 
3. Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman 
MD.  Epidemiology and cost of ventral hernia repair: making the case for hernia 
research.  Hernia 2012; 16:179-183. Epub 2011 Sept 9. 
 
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 JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-
term follow-up of a randomized controlled trial of suture versus mesh repair 
incisional hernia. Ann Surg.  2004 Oct; 240(4): 578 – 583; discussion 583-5. 
 
6. van Geffen HK, Simmermacher RK, van Vroonhoven TJ, van der Werken C. Surgical 
treatment of large contaminated abdominal wall defects. J Am Coll Surg. 2005 Aug; 
201(2): 206 – 212. 
 
7. George CD, Ellis H. The results of incisional hernia: a twelve-year review. Ann R 
Coll Surg Engl. 1986 Jul; 68(4):185-187. 
 
8. 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. 
 
9. Ramirez OM, Ruas E, Dellon AL. “Components separation” method for closure of 
abdominal-wall defects: An anatomic and clinical study. Plast Reconstruct Surg. 1990 
Sep; 86(3):519 – 526. 
 
10. DiBello JN Jr., Moore JH Jr. Sliding myofascial flap of the rectus abdominus muscle 
for the closure of recurrent ventral hernias. Plast Reconstr Surg. 1996 Sep; 98(3):464 
– 469. 
 
11. Girotto JA, Ko MJ, Redett R, Muehlberger T, Talamini M, Chang B. Closure of 
chronic abdominal wall defects: a long-term evaluation of the components separation 
method. Ann Plast Surg. 1999 Apr; 42(4):385 – 395; discussion 394-5. 
 
12. Shestak KC, Edington HJ, Johnson RR. The separation of anatomic components 
technique for the reconstruction of massive midline abdominal wall defects: anatomy, 

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surgical technique, applications, and limitations revisited. Plast Reconstr Surg. 2000 
Feb; 105(2):731- 738; quiz 739. 
 
13. Lowe JB, Garza JR, Bowman JL, Rohrich RJ, Strodel WE. Endoscopically assisted 
“components separation technique” for closure of abdominal wall defects. Plast 
Reconstr Surg. 2000 Feb; 105(2):720 – 729; quiz 730. 
 
14. LeBlanc KA, Booth WV. Laparoscopic repair of incisional abdominal hernias using 
expanded polytetraﬂuoroethylene: preliminary ﬁndings. Surg Laparosc Endosc. 1993; 
3:39 – 41. 
 
15. Heniford, BT, Park, A, Ramshaw, BJ, Voeller G.  Laparoscopic Repair of Ventral 
Hernias - Nine Years’ Experience With 850 Consecutive Hernias 
Ann Surg 2003;238: 391– 400. 
 
16. Orenstein SB, Dumeer JL, Monteagudo J, Poi MJ, Novitsky YW. Outcomes of 
laparoscopic ventral hernia repair with routine defect closure using "shoelacing" 
technique. Surg Endosc (2011) 25: 1452-1457. 
 
17. Martin DP, Williams SF.  Medical applications of poly-4-hydroxybutyrate: a strong 
flexible absorbable biomaterial.  Biochemical Engineering Journal 2003; 16:97-105.  
 
18. Chen GQ, Wu Q. The application of polyhydroxyalkanoates as tissue engineering 
materials. Biomaterials. 2005 Nov; 26(33):6565-78.  
 
19. Wu Q, Wang Y, Chen GQ.  Medical application of microbial biopolyesters 
polyhydroxyalkanoates.  Artif Cells Blood Substit Immobil Biotechnol. 2009; 
37(1):1-12. doi: 10.1080/10731190802664429. Epub 2009 Jan 8. 
 
20. 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 Oct; 184(2):766-73. doi: 10.1016/j.jss.2013.03.044. Epub 2013 Apr 2. 
 
21. Deeken CR, Matthews BD. Characterization of the Mechanical Strength, Resorption 
Properties, and Histologic Characteristics of a Fully Absorbable Material (Poly-4-
Hydroxybutyrate – PHASIX Mesh) in a Porcine Model of Hernia Repair. ISRN 
Surgery. 2013 May 28; 2013:238067. doi: 10.1155/2013/238067. Print 2013. 
 
22. Data on file. Warwick, RI, USA: Davol Inc. 
 
23. Mangram AJ, Horan TC, Peron ML, Silver LC, Jarvis WR. Guidance for prevention 
of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) 
Hospital Infection Control Practices Advisory Committee. Am J Infect Control.1999; 
Apr 27 (2):97-132; quiz 133-4; discussion 96. 
 

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24. CDC Surgical Site Infection (SSI) Event Protocol 
http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf 
 
25. Routine Culture Guidelines Adapted From: SPECIMEN COLLECTION:  
GUIDELINES FOR BEST PRACTICES. Center for Health Hazards Preparedness. 
University of Louisville. School of Public Health and Information Sciences. June 
2007. 
 
  
 
 
 

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18 APPENDICES 
 
Appendix 1: Lead Principal Investigator  
Name:  
William Hope 
Address:  
2131 S. 17th Street 
Wilmington, NC 28401 
Phone:  
+1 (910) 343-7000 Office 
 
 
+1 (910) 465-6679 Mobile 
Email:  
William.Hope@seahec.net 
 
 
 

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Appendix 2: Surgical Site Infection Classification24  
 
Superficial Incisional Surgical Site Infections (SSI) 
Infection occurs within 30 days after the operative procedure (where day 1 = procedure 
day) 
AND 
involves only the skin or subcutaneous tissue of the incision  
AND  
at least one of the following: 
A. Purulent drainage from the superficial incision or subcutaneous tissue. 
B. Organisms isolated from an aseptically obtained culture of fluid or tissue from the 
superficial incision. 
C. Superficial incision that is deliberately opened by a surgeon, attending physician or 
other designee and is culture positive or not cultured 
AND 
Patient has at least one of the following signs or symptoms: pain or tenderness; 
localized swelling; erythema; or heat. A culture negative finding does not meet this 
criterion. 
D. Diagnosis of a superficial incisional SSI by the surgeon or attending physician or 
other designee. 
 
COMMENT: There are two specific types of superficial incisional SSIs: 
1. Superficial Incisional Primary (SIP) –a superficial incisional SSI that is identified in the 
primary incision in a patient that has had an operation with one or more incisions (e.g., 
C -section incision or chest incision for CBGB) 
2. Superficial Incisional Secondary (SIS) – a superficial incisional SSI that is identified in 
the secondary incision in a patient that has had an operation with more than one 
incision (e.g., donor site incision for CBGB) 
 
The following do not qualify as criteria for meeting the definition of superficial SSI: 
 Diagnosis/treatment of cellulitis (redness/warmth/swelling), by itself, does not meet 
criterion d for superficial incisional SSI.  An incision that is draining or culture (+) is 
not considered a cellulitis. 
 A stitch abscess alone (minimal inflammation and discharge confined to the points of 
suture penetration). 
 
Deep Incisional SSI 
Infection occurs within 90 days after the operative procedure (for herniorrhaphy)(where 
day 1 = procedure day)   
AND 
involves deep soft tissues of the incision (e.g., fascia and muscle layers)  
AND 
patient has at least one of the following: 
a. Purulent drainage from the deep incision. 

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b. A deep incision spontaneously dehisces or is deliberately opened or aspirated by a 
surgeon, attending physician or other designee and is culture positive or not 
cultured 
AND 
patient has at least one of the following signs or symptoms:  fever (>38°C), 
localized pain or tenderness.  A culture negative finding does not meet this 
criterion. 
c. An abscess or other evidence of infection involving the deep incision that is 
detected on gross anatomical or histopathologic exam, or imaging test. 
 
COMMENTS: There are two specific types of deep incisional SSIs: 
 
1.  Deep Incisional Primary (DIP) –a deep incisional SSI that is identified in a primary 
incision in a patient that has had an operation with one or more incisions (e.g., C-
section incision or chest incision for CBGB) 
2.  Deep Incisional Secondary (DIS) – a deep incisional SSI that is identified in the 
secondary incision in a patient that has had an operation with more than one incision 
(e.g., donor site incision for CBGB) 
 
Organ/Space SSI 
Must meet the following criteria: 
Infection occurs within 90 days after the operative procedure (for herniorrhaphy)(where 
day 1 = procedure day)   
AND 
infection involves any part of the body deeper than the fascial/muscle layers, that is opened 
or manipulated during the operative procedure 
AND 
patient has at least one of the following: 
a.   purulent drainage from a drain that is placed into the organ/space (e.g., closed 
suction drainage system, open drain, T-tube drain, CT guided drainage) 
b.  organisms isolated from an aseptically-obtained culture of fluid or tissue in the 
organ/space 
c.   an abscess or other evidence of infection involving the organ/space that is 
detected on gross anatomical or histopathologic exam, or imaging test 
AND 
meets at least one of the organ/space infection site “intraabdominal” criteria: 
1. Patient has organisms cultured from abscess and/or purulent material from 
intraabdominal space. 
2. Patient has abscess or other evidence of intraabdominal infection on gross anatomic 
or 
histopathologic exam. 
3. Patient has at least two of the following signs or symptoms: fever (>38.0°C±), 
nausea*,   vomiting*, abdominal pain*, or jaundice*  
And at least one of the following: 
a. organisms seen on culture or Gram stain of drainage or tissue obtained during 
invasive procedure or from an aseptically-placed drain (e.g., closed suction 
drainage system, open drain, T-tube drain, CT guided drainage) 

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b. organisms cultured from blood and imaging test evidence suggestive of 
infection (e.g., ultrasound, CT scan, MRI, radiolabel scans [gallium, 
technetium, etc.] or on abdominal x-ray), which if equivocal is supported by 
clinical correlation. 
* With no other recognized cause 
± As documented in the medical record 
 
 

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Appendix 3: Surgical Wound Classification23 
 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, nonpurulent 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. 
 
 

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Appendix 4: Routine Culture25 
BASIC GUIDELINES FOR COLLECTION 
 
1. Collect the material from the site in which the etiologic agent will most likely be found. 
 
2. Obtain cultures prior to administration of antibiotics whenever possible. 
 
3. Collect adequate volume of material.  Inadequate amounts of specimen may yield false 
negative results. 
 
4. Collect specimen in a manner that minimizes or eliminates contamination from 
indigenous flora as possible to ensure that the sample will be representative of the 
infected site. 
 
5. Use appropriate collection devices, transport media, and sterile, leak proof containers. 
 
6. Use sterile equipment and aseptic technique to collect specimen to prevent introduction 
of microorganisms during invasive procedures. 
 
7. Clearly label the specimen including specific information regarding site of collection 
(e.g., blood obtained via blue lumen of right subclavian central catheter) and complete 
the ordering process. 
 
8. Identify the specimen source and/or specific site correctly so that proper processing 
methods and culture media will be selected by the laboratory personnel. 
 
9. Deliver the specimen promptly to the laboratory.  Delay in transport may compromise 
the specimen. 
 
SUBCUTANEOUS AND SKIN SPECIMEN: 
 
A. Superficial Wound (bacterial) 
1. Syringe aspiration is preferable to swab collection. 
 
2. Disinfect the surface of the wound with 70% alcohol followed by povidone-iodine or 
povidone-iodine alone.  Allow the skin disinfectant to dry prior to collection the 
specimen.  Remove iodine with alcohol after procedure to prevent irritation. 
 

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3. Using a 3 – 5 ml syringe with a small gauge needle, a physician will aspirate the 
deepest portion of the lesion.  If a vesicle is present, collect both fluid and cells from 
the base of the lesion. 
 
4. If the initial aspiration fails to obtain material, inject sterile, preservative-free saline 
subcutaneously then repeat aspiration if necessary. 
 
5. If no material is obtained, rinse needle and syringe with broth by drawing the culture 
medium through the needle into the syringe. 
 
WOUNDS, ASPIRATES, AND TISSUE SPECIMEN: 
 
A. Deep Wounds or Abscesses: 
 
1. Disinfect the surface with 70% alcohol and a povidone-iodine solution.  Remove 
iodine with alcohol after procedure to prevent irritation. 
 
2. Aspirate the deepest part of the lesion, avoiding contamination by the wound surface.  
If collection is done at surgery, a portion of the abscess wall should also be sent for 
culture. 
 
B. Punch Biopsy: 
 
1. Disinfect the skin surface with 70% alcohol and then with a povidone-iodine solution.  
Remove iodine with alcohol to prevent irritation. 
2. Collect 3 – 4 mm sample with a dermal punch. 
3. Submit for culture in a sterile container without formalin. 
4. Place specimen onto a sterile gauze pad moistened with preservative-free saline in 
order to keep the specimen from drying. 
 
C. Soft Tissue Aspirate 
 
1. Disinfect the skin surface with 70% alcohol and then with a povidone-iodine solution.  
Remove tincture of iodine with alcohol to prevent irritation. 
 
2. Aspirate the deepest portion of the lesion or sinus tract.  Be careful to avoid 
contamination by the wound surface. 
 

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Appendix 5: 2014 Joslin Clinical Guideline for Adults with Diabetes 
 
Diabetes Mellitus – Diagnostic Criteria (Non-Pregnant Adults) 
 
Random plasma glucose >200 mg/dl and symptoms of diabetes (polyuria, polydipsia, ketoacidosis, or 
unexplained weight loss)  
 
OR 
 
Fasting plasma glucose (FPG)* >126 mg/dl  
 
OR 
 
Results of a 2-hour 75-g Oral Glucose Tolerance Test (OGTT)* >200 mg/dl  
 
OR 
 
Glycated Hemoglobin (A1C)>6.5%** 
 
*These tests should be confirmed by a repeat test, on a different day, unless unequivocally high 
** Only an A1C test that has been referenced to an accepted laboratory method (standardized) should be 
utilized for diagnostic purposes