A Comparison of the Outcomes in Fortiva and Strattice Mesh
Phase: NA
Conditions: Ventral Hernia
Sponsor: Wake Forest University Health Sciences

Official Title:  A Comparison of the Outcomes in Fortiva and Strattice Mesh  
NCT05572021
IRB Approval Date:  04/28/2025

Protocol version: 5 
 
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Study Title: A Comparison of the Outcomes in Fortiva and Strattice Mesh 
 
Principal Investigator: Vedra A. Augenstein, MD  
Co-investigator(s):  
 
Sponsor or funding source: RTI Surgical 
 
Background, Rationale and Context 
Ventral hernia repair (VHR) is a common procedure performed by general surgeons with an estimated 
400,000 per year performed in the United States [1]. Based on available literature, experts strongly 
recommend mesh reinforcement for all elective VHR of hernias at least 2cm in diameter with no 
contamination. There is currently no conclusive recommendation for mesh reinforcement in emergent 
VHR, VH < 2cm, or in the setting of contamination [2]. There are numerous types of mesh available, 
including biologic and synthetic. Because synthetic mesh has been associated with a host of 
complications including infection, adhesions, bowel obstruction, and enterocutaneous fistula, biologic 
meshes were developed and are widely available in various types. They provide an acellular collagen 
matrix on which the host tissue can regenerate [3]. Biologic meshes are generally significantly more 
expensive than their synthetic counterparts [4,5] although long-term cost analysis has suggested that 
biologic mesh may be more cost-effective due to the long-term complication rates for synthetic mesh [5]. 
Few studies have compared the various types of biologic mesh [6]. In this study, we aim to compare two 
different types of biologic mesh in VHR: Fortiva and Strattice to determine the difference in rates of 
hernia recurrence and mesh related complications. Fortiva is an FDA cleared (510(k)) biologic mesh that 
is “substantially equilvalent” to Strattice mesh but at a reduced cost making the mesh more cost efficient. 
The risks associated with this study are expected to be the same as those associated with a VHR utilizing 
Strattice mesh.  
 
Goal 
The goal of this research study is to show that Fortiva porcine dermis biologic mesh is equivalent 
to Strattice biologic mesh with respect to hernia recurrence rates and mesh related complication 
rates. Fortiva is an FDA cleared (510(k)) hernia mesh that is substantially equivalent to Strattice 
but at a reduced cost. The goal is to show similar equivalent outcomes to justify the use of 
Fortiva.  
 
Objectives 
Primary Objective: To determine the hernia recurrence rates for RTI Surgical biologic mesh 
(Fortiva) compared to Strattice  
Hypothesis: Fortiva mesh will have equivalent rates of hernia recurrence compared to Strattice 
 
Secondary Objective(s): To determine the mesh related complications for RTI Surgical biologic 
mesh (Fortiva) compared to Strattice 
Hypothesis: Fortiva mesh will have equivalent rates of mesh related complications compared to 
Strattice 
 
Methods and Measures 
 
Design 
This study will be a prospective, matched study of patients using Fortiva biologic mesh to 
determine the rates of hernia recurrence and mesh related complication compared to a 
retrospective cohort of patients who received Strattice mesh. The indication CLASP surgeons 
use for biologic mesh use is in contaminated/dirty cases; surgeons are sometimes unable to 
determine this until they are in the OR. To account for the nature of biologic mesh use in 

Protocol version: 5 
 
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ventral hernia repair, patients whom an attending surgeon uses Fortiva mesh in the OR when 
it was not otherwise planned (i.e. the surgeon changed the plan intraoperatively) will be 
approached in the postoperative space (i.e. follow-up clinic visits or phone calls) to be 
consented for inclusion in the study. In the event a subject cannot be reached in clinic prior to 
the end of their standard of care follow-up, a full waiver of consent will be requested to 
capture all patients and not unnecessarily skew the results. The rates of hernia recurrence and 
mesh related complications will be compared to determine equivalence. Patients who meet 
the inclusion and exclusion criteria will be prospectively enrolled to receive a Ventral Hernia 
Repair (VHR) using Fortiva biologic mesh and will be compared to a retrospective cohort of 
patients with a VHR that utilized Strattice mesh. All procedures and clinical care have 
already occurred for the participants who received a VHR with Strattice mesh. Participants 
will be propensity matched in a 1:3 (Fortiva : Strattice) fashion based on age, sex, and hernia 
defect size to control for confounding variables.  
 
Setting 
Hybrid Academic Medical Center 
 
Subjects selection criteria 
Patients who meet the following criteria will be included in the study.  
• 
Inclusion Criteria 
o Aged at least 18 years 
o Ventral Hernia requiring surgical repair 
• 
Exclusion Criteria 
o Pregnant women 
o Sensitivity to Polysorbate 20 
• 
Sample Size 
This study will have a sample n=200 (n=50 Fortiva, n=150 Strattice). All participants may 
not be eligible for the study, so this study may consent up to 100 prospective participants to 
achieve the 50-participant sample size. This study will serve as a pilot study to compare rates 
of hernia recurrence and mesh related complications between Fortiva and Strattice. Our group 
has published research in press showing a 4% hernia recurrence rate for Strattice mesh. Based 
on an alpha level of 0.05 and a beta of 0.80 and a non-inferior limit of 2% the sample size per 
group would be 1188. Based on these numbers we would like to do a matched pilot study 
with a more feasible sample size of 200 participants (n=50 Fortiva(retrospective and 
prospective), n=150 Strattice(retrospective)). 
 
Interventions and Interactions 
This study will involve surgical ventral hernia repair utilizing a biologic hernia mesh (Fortiva). Fortiva 
mesh may be used by a CLASP surgeon in ventral hernia repair in patients even if they choose not to 
participate in the research study.  
• 
This study will involve the implantation of RTI Surgical Fortiva biologic mesh in the 
reconstruction of the abdominal wall. Mesh size, position, location and procedure will be 
determined and performed by an attending surgeon from Carolinas Laparoscopic & Advanced 
Surgery Program (CLASP).  
• 
Study participants will be asked to follow up for at least 36 months.  
o Follow up will include participants being seen back in clinic as part of our standard of 
care after a ventral hernia repair or contacted via telephone at 2-weeks, 6-months, 1-year, 
2-year, 3-year to evaluate the participants progress and recovery using the Fortiva mesh 
 
Data elements to be collected are listed below: 

Protocol version: 5 
 
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• 
Age 
• 
Sex 
• 
Race 
• 
Body mass index (BMI) 
• 
Comorbidities 
o Asthma 
o Cirrhosis 
o Congestive heart failure (CHF) 
o COPD 
o Coronary Artery Disease 
o Current Steroid Use 
o Current Anticoagulant Use 
o Diabetes history 
o Hemoglobin A1c 
o End Stage renal Disease 
o History of Cancer 
o Hypertension 
o Obstructive Sleep Apnea 
o Peripheral Vascular Disease 
o Smoking history 
o Current smoking status 
o Stroke History 
o Transplant patient 
• 
Hernia defect size 
• 
At the time of Surgery 
o Fistula present(y/n) 
o Mesh infection(y/n) 
• 
Mesh size 
• 
Mesh type 
• 
Mesh location (preperitoneal, intraperitoneal, inlay/bridging, retrorectus, onlay) 
• 
Number of hernia failures 
• 
Number of hernia procedures 
• 
Type of hernia procedures (emergent vs elective) 
• 
Dates of Surgery 
• 
Use of botox (y/n) 
• 
American Society of Anesthesiologist (ASA) Classification 
• 
Operative findings 
o Complete Fascial closure(y/n) 
o Enterotomy 
• 
Use of component separation techniques (external oblique release or transversus abdominus 
release) to enable closure 
• 
Length of Operation 
• 
Recurrence(y/n) 
• 
TAPP block 
• 
Mesh resection 
• 
Concomitant procedures 
• 
Concurrent panniculectomy 
• 
Mesh fixation (sutures/glue/none) 
• 
Delayed primary skin closure(y/n) 

Protocol version: 5 
 
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• 
Wound complications(y/n) 
o Wound cellulitis 
o Wound infection 
o Surgical site infection (SSI) 
o Superficial wound breakdown 
o Intra-abdominal abscess 
o Seroma requiring intervention 
o Mesh infection 
• 
Length of Stay 
• 
Mortality 
• 
30-day readmission 
• 
Pulmonary failure (y/n) 
• 
Post-operative follow-up time 
 
Outcome Measure(s) 
This study will measure the rate of hernia recurrence and mesh related complications for patients 
undergoing VHR with RTI Surgical Fortiva biologic mesh compared with patients who underwent VHR 
with Strattice mesh.  
 
Analytical Plan 
Results will be analyzed initially using descriptive statistics. Comparison between groups will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous variables.  
Regression analysis will be performed to identify independent outcome predictors.  Other inferential 
statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
Subjects will be recruited in the attending physician’s clinic. The attending physician will present the 
study initially and if the patient is interested a member of the study team (attending physician, fellow, 
resident, research manager or research associate) will fully introduce the study via protocol and ICF. 
Subjects may also be recruited via telephone if they have already been seen in clinic and will not be seen 
again prior to surgery but may otherwise be a candidate for the study. Telephone calls will be made prior 
to the day of surgery. Patients contacted via telephone will be introduced to the study and, if interested, 
will be noted as such and asked to sign the ICF on the day of surgery.  
 
No preference will be given to any sex, race, or ethnicity. Patients who meet the inclusion/exclusion 
criteria will be recruited with the same interest level. PHI will be kept confidential in the clinic as well as 
before and after telephone calls to gauge recruitment interest.  
 
Informed Consent 
Signed informed consent will be obtained from each subject in the prospective group. Informed consent 
will be obtained by a member of the research team (PI, Co-I, fellow, resident, research manager, or 
research associate) in the clinic prior to the date of surgery. Informed consent may be obtained on the day 
of surgery, if the patient has been contacted previously prior to the day of surgery, via telephone, and has 
stated an interest in participating in the research study.  
 
A full waiver of consent/assent and a waiver HIPAA authorization will be requested for patients in the 
retrospective group as their procedures and outcomes have already happened and reporting on the 
procedures and outcomes will not adversely affect the patient’s care. Access to age in years and 

Protocol version: 5 
 
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office/clinic notes will be requested. Access to patient name, phone number and MRN will be the only 
identifying information requested. The study material is identifiable; however, study data will be linked 
by an identifier assigned to each participant and the identifier will be the only information maintained in 
the study data. The standard operating procedure for our group is to keep all study data in a locked suite, 
locked file cabinet, or electronically via password protection on a secure computer, on a secure network. 
Identifiers will be kept as part of the participants’ medical record indefinitely. Access to this information 
is requested to identify patients who have already undergone VHR with Strattice mesh and would be of 
the retrospective cohort.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy 
and confidentiality, only a unique study identifier will appear on the data collection form.  Any 
collected patient identifying information corresponding to the unique study identifier will be 
maintained on a linkage file, store separately from the data.  The linkage file will be kept secure, with 
access limited to designated study personnel.  Following data collection subject identifying 
information will be destroyed three years post study closure via overwriting and deleting electronic 
file and disposing of paper PHI in designated PHI destruction bins, consistent with data validation 
and study design, producing an anonymous analytical data set.  Data access will be limited to study 
staff.  Data and records will be kept locked and secured, with any computer data password protected.  
No reference to any individual participant will appear in reports, presentations, or publications that 
may arise from the study. 
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study staff. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes 
will be promptly reported by the principal investigator or designated member of the research team to 
the IRB and sponsor or appropriate government agency if appropriate. 
 
References 
1. Harris HW, Primus F, Young C, Carter JT, Lin M, Mukhtar RA, Yeh B, Allen IE, Freise C, Kim E, 
Sbitany H, Young DM, Hansen S. Preventing Recurrence in Clean and Contaminated Hernias 
Using Biologic Versus Synthetic Mesh in Ventral Hernia Repair: The PRICE Randomized 
Clinical Trial. Ann Surg. 2021 Apr 1;273(4):648-655. doi: 10.1097/SLA.0000000000004336. 
PMID: 33443907. 
2. Liang MK, Holihan JL, Itani K, Alawadi ZM, Gonzalez JR, Askenasy EP, Ballecer C, Chong HS, 
Goldblatt MI, Greenberg JA, Harvin JA, Keith JN, Martindale RG, Orenstein S, Richmond B, 
Roth JS, Szotek P, Towfigh S, Tsuda S, Vaziri K, Berger DH. Ventral Hernia Management: 
Expert Consensus Guided by Systematic Review. Ann Surg. 2017 Jan;265(1):80-89. doi: 
10.1097/SLA.0000000000001701. PMID: 28009730. 
3. Olavarria OA, Bernardi K, Dhanani NH, Lyons NB, Harvin JA, Millas SG, Ko TC, Kao LS, Liang 
MK. Synthetic versus Biologic Mesh for Complex Open Ventral Hernia Repair: A Pilot 
Randomized Controlled Trial. Surg Infect (Larchmt). 2021 Jun;22(5):496-503. doi: 
10.1089/sur.2020.166. Epub 2020 Dec 1. PMID: 33259771; PMCID: PMC8349713. 
4. Rosen MJ, Krpata DM, Petro CC, Carbonell A, Warren J, Poulose BK, Costanzo A, Tu C, Blatnik 
J, Prabhu AS. Biologic vs Synthetic Mesh for Single-stage Repair of Contaminated Ventral 

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Hernias: A Randomized Clinical Trial. JAMA Surg. 2022 Apr 1;157(4):293-301. doi: 
10.1001/jamasurg.2021.6902. PMID: 35044431; PMCID: PMC8771431. 
5. Schneeberger S, Phillips S, Huang LC, Pierce RA, Etemad SA, Poulose BK. Cost-Utility Analysis 
of Biologic and Biosynthetic Mesh in Ventral Hernia Repair: When Are They Worth It? J Am 
Coll Surg. 2019 Jan;228(1):66-71. doi: 10.1016/j.jamcollsurg.2018.10.009. Epub 2018 Oct 22. 
PMID: 30359837. 
6. Taibi A, Derbal S, Durand Fontanier S, Christou N, Fredon F, Bouvier S, Fabre A, Rivaille T, 
Valleix D, Mathonnet M. Implantation of biologic mesh in ventral hernia repair-does it make 
sense? Surg Endosc. 2021 Feb;35(2):702-709. doi: 10.1007/s00464-020-07435-5. Epub 2020 Feb 
14. PMID: 32060746. 
 

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Appendix 
1. Data collection form 
2. ICF 
3. 510(k) FDA Cleared as “Substantially Equilvalent” to Strattice Mesh