Fortiva vs Strattice Mesh for Hernia Repair
Recruiting in Palo Alto (17 mi)
Overseen byTodd Heniford, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Pregnancy
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial compares two types of surgical mesh, Fortiva and Strattice, used to repair belly hernias. It aims to see which mesh is better at preventing hernias from coming back and causing fewer complications. The study involves patients who need hernia repair surgery and matches them based on age, sex, and hernia size.
Do I need to stop my current medications for the hernia repair trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Fortiva and Strattice for hernia repair?
Research shows that Strattice, a type of biologic mesh, is effective in hernia repair as it integrates well with human tissue, supports tissue regeneration, and has a lower infection rate compared to some other biologic meshes. It also demonstrates resistance to rejection and can support skin grafts, making it a promising option for complex hernia repairs.
12345Is Strattice mesh safe for hernia repair in humans?
Strattice mesh has been shown to integrate well with human tissue, even in challenging wound conditions, and is generally resistant to rejection. In studies, it demonstrated a low rate of complications like infection and was effective in achieving abdominal wall closure, even in patients with multiple health issues.
35678How does the Fortiva treatment for hernia repair differ from other treatments?
Fortiva is a type of biologic mesh made from porcine (pig) dermis, which is designed to integrate with the body's tissues more naturally than synthetic meshes. This treatment is unique because it is non-cross-linked, meaning it retains more of its natural properties, potentially leading to better tissue integration and reduced risk of complications compared to synthetic options.
235910Eligibility Criteria
This trial is for individuals who need surgery to repair a ventral hernia, which is a bulge of tissues through an opening within abdominal muscles. Pregnant women are not eligible to participate.Inclusion Criteria
I need surgery for a hernia in my abdomen.
Exclusion Criteria
Pregnant women
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo ventral hernia repair using Fortiva biologic mesh
1-2 weeks
Follow-up
Participants are monitored for hernia recurrence and mesh-related complications
1 year
Participant Groups
The study compares two types of mesh used in hernia repair surgeries: Fortiva and Strattice. It looks at how often the hernia comes back after using each mesh and what complications might arise with each type.
2Treatment groups
Experimental Treatment
Active Control
Group I: ProspectiveExperimental Treatment1 Intervention
Participants enrolled to ventral hernia repair with Fortiva mesh
Group II: RetrospectiveActive Control1 Intervention
Retrospective participants with ventral hernia repair using Strattice mesh
Fortiva is already approved in United States for the following indications:
🇺🇸 Approved in United States as Fortiva for:
- Abdominal Wall Reconstruction
- Hernia Repair
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carolinas Medical CenterCharlotte, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. [2021]Biologic prostheses are designed to support tissue regeneration rather than just result in a strong scar plate, as is the case with synthetic mesh. It is not known if these newer materials will result in earlier return to normal activities and/or less post-herniorrhaphy groin pain. METHOD/STUDY DESIGN: A prospective, randomized, controlled, third-party-blinded multicenter trial was designed to compare the use of a non-cross linked porcine dermis biologic graft [Strattice(TM) Reconstructive Tissue Matrix (RTM), LifeCell, Branchburg, NJ] versus light weight, large pore polypropylene mesh (UltraPro(TM), Ethicon, Somerville, NJ). The study design called for recruitment of 170 men. These men are being followed for a minimum of 2 years. The primary aim of this study is to compare the safety and effectiveness of the two materials in a Lichtenstein inguinal hernia repair as measured by resumption of activities of daily living. Secondary outcomes include chronic pain, postoperative complications and the incidence of re-herniation at 12 and 24 months.
Delayed repair in a case of forearm fascial muscle herniation using non-cross-linked acellular porcine dermal matrix. [2022]The options for treatment of symptomatic muscle herniation in the limbs traditionally include fasciotomy, direct repair, tendon weave graft (palmaris longus), fascial graft (tensor fascia lata), and synthetic mesh (prolene). A recent case report has described the use of acellular cadaveric dermal matrix to reconstruct fascial defects in 2 cases. We describe the use of Strattice, a non-cross-linked acellular porcine dermal matrix, as a fascial underlay graft in a case of symptomatic upper limb muscle herniation. We propose that Strattice has the advantages over cadaveric dermal matrices in terms of avoiding the use of human donor tissue. It has suitable tensile properties to be used for reconstructing fascial defects.
Porcine acellular dermal matrix (PADM) vascularises after exposure in open necrotic wounds seen after complex hernia repair. [2021]Biological alternatives to synthetic meshes are increasingly utilised in complex abdominal wall reconstruction. There is a lack of evidence demonstrating that non-cross-linked porcine acellular dermal matrix vascularizes and integrates with human tissue in suboptimal wound conditions. We aimed to evaluate these properties in Strattice™ (Life Cell Inc., Branchburg, NJ) following ventral hernia repair. A retrospective review of patients with high-risk ventral hernia repair utilising Strattice™ as an onlay after open component separation was conducted. Patients with postoperative wound exploration and exposure of the onlay were included in this review. One patient underwent punch biopsy for histological analysis. Eleven patients with wound complications necessitating postoperative debridement and exposure of Strattice™ onlay were identified. The onlay was partially debrided in two cases, and one case required complete excision. Vascularisation was clinically evident in 10 of 11 cases (91%) as demonstrated by the presence of granulation tissue and/or the ability to support a skin graft. Histological analysis of one onlay 3 months postoperatively showed neovascularisation and collagen remodelling with minimal inflammatory response. Strattice™ demonstrated resistance to rejection, ability to undergo vascularisation and incorporation into host tissues in sub-optimal wound conditions following ventral hernia repair.
Abdominal ventral hernia repair with current biological prostheses: an experimental large animal model. [2011]Biologic prostheses have emerged to address the limitations of synthetic materials for ventral hernia repairs; however, they lack experimental comparative data. Fifteen swine were randomly assigned to 1 of 3 bioprosthetic groups (DermaMatrix, AlloDerm, and Permacol) after creation of a full thickness ventral fascial defect. At 15 weeks, host incorporation, hernia recurrence, adhesion formation, neovascularization, inflammation, and biomechanical properties were assessed. No animals had hernia recurrence or eventration. DermaMatrix and Alloderm implants demonstrated more adhesions, greater inflammatory infiltration, and more longitudinal laxity, but near identical neovascularization and tensile strength to Permacol. We found that porcine acellular dermal products (Permacol) contain following essential properties of an ideal ventral hernia repair material: low inflammation, less elastin and stretch, lower adhesion rates and cost, and more contracture. The addition of lower cost xenogeneic acellular dermal products to the repertoire of available acellular dermal products demonstrates promise, but requires long-term clinical studies to verify advantages and efficacy.
Outcome of abdominal wall hernia repair with biologic mesh: Permacol™ versus Strattice™. [2022]The use of biologic mesh in abdominal wall operations has gained popularity despite a paucity of outcome data. Numerous biologic products are available with virtually no clinical comparison studies. A retrospective study was conducted to compare patients who underwent abdominal wall hernia repair with Permacol™ (crosslinked porcine dermis) and Strattice™ (noncrosslinked porcine dermis). Of 270 reviewed patients, 195 were implanted with Permacol™ and 75 with Strattice™. Ventral hernia repairs comprised the majority (85% for Permacol, 97% for Strattice™). Postoperative infection rate was lower in the Strattice™ group (5 vs 21%, P
Critical analysis of Strattice performance in complex abdominal wall reconstruction: intermediate-risk patients and early complications. [2022]The purpose of this study was to analyze the performance of a porcine-derived acellular dermal matrix (Strattice Reconstructive Tissue Matrix) in patients at increased risk for perioperative complications. We reviewed medical records for patients with complex abdominal wall reconstruction (AWR) and Strattice underlay from 2007 to 2010. Intermediate-risk patients were defined as having multiple comorbidities without abdominal infection. Forty-one patients met the inclusion criteria (mean age, 60 years; mean body mass index, 35.5 kg/m(2)). Comorbidities included coronary artery disease (63.4%), diabetes mellitus (36.6%), and chronic obstructive pulmonary disease (17.1%). Fascial closure was achieved in 40 patients (97.6%). Average hospitalization was 6.4 days (range, 1-24 days). Complications included seroma (7.3%), wound dehiscence with Strattice exposure (4.9%), cellulitis (2.4%), and hematoma (2.4%). All patients achieved abdominal wall closure with no recurrent hernias or need for Strattice removal. Patients with multiple comorbidities at intermediate risk of postoperative complications can achieve successful, safe AWR with Strattice.
The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. [2022]The treatment of hernias remains controversial, with multiple prosthetic meshes being exalted for a variety of their characteristics. In the event of incarcerated/strangulated hernias and other potentially contaminated fields the placement of prosthetic material remains controversial because of increased risk of recurrence and infection. Porcine small intestinal submucosa mesh (Surgisis, Cook Bloomington, IN) has been demonstrated safe and feasible in laparoscopic hernia repairs in this scenario. We present our 5-year experience, with placement of Surgisis mesh in potentially or grossly contaminated fields.
Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. [2022]The aim of this study was to compare the efficacy and the complications associated with the use of two new bioactive meshes, Surgisis Gold 8-ply mesh, a product obtained by the processing of porcine small intestine sub-mucosa (Cook Surgical, Bloomington, IN, USA), and Alloderm, processed cadaveric human acellular dermis (Life Cell Corporation, Branchburg, NJ, USA), for ventral herniorrhaphy.
Acellular Dermal Matrix Susceptibility to Collagen Digestion: Effect on Mechanics and Host Response. [2023]Various tissue origins and manufacturing processes can differentially affect the retention of native properties of acellular dermal matrices (ADMs); however, comparative studies are limited. Head-to-head comparisons between different configurations of porcine-derived Strattice (Allergan Aesthetics, an AbbVie Company, Irvine, CA) and bovine-derived SurgiMend (Integra LifeSciences, Billerica, MA) ADMs were performed to evaluate mechanical integrity and host tissue biologic response. Thermodynamic profile and morphology, which affect retention of mechanical strength, were evaluated through differential scanning calorimetry, scanning electron microscopy, and histology. Mechanical strength was assessed through tensile testing following collagenase exposure in vitro and following subcutaneous implantation in a rodent model. Host biologic response was evaluated through histopathology. Compared with respective native tissues, reductions in onset melting temperature following tissue processing were smaller for Strattice Firm versus SurgiMend 1.0 (Δ0.79°C vs. Δ5.77°C), Strattice Extra Thick versus SurgiMend 3.0 (Δ1.57°C vs. Δ4.79°C), and Strattice Perforated versus SurgiMend Microperforated (Δ1.18°C vs. Δ7.76°C), with similar trends for peak melting temperature. Strattice maintained native dermal architecture versus compacted collagen with process-induced interstices observed for SurgiMend. Strattice Firm, Extra Thick, and Perforated retained 33.44%, 65.65%, and 17.20% of initial strength after 48 h exposure to excess collagenase, while the SurgiMend ADMs were completely digested by 48 h. At 6 weeks postimplantation, both Strattice and SurgiMend showed minimal inflammatory response, but greater fibroblast repopulation was evident for Strattice. Strattice Firm had higher maximum load (145.85 ± 33.05 N/cm vs. 24.29 ± 12.35 N/cm, p ≤ 0.01), maximum stress (8.20 ± 1.91 MPa vs. 2.24 ± 1.27 Mpa, p ≤ 0.01), and stiffness (7491.00 ± 1981.32 N/cm vs. 737.56 ± 292.55 N/cm, p ≤ 0.01) than SurgiMend 1.0. Strattice Extra Thick had lower maximum load (198.54 ± 58.79 N/cm vs. 303.08 ± 76.76 N/cm, p < 0.05) than SurgiMend 3.0, but similar maximum stress (6.96 ± 1.78 Mpa vs. 8.73 ± 2.15 Mpa) and stiffness (13386.11 ± 3123.28 N/cm vs. 9389.02 ± 4860.67 N/cm). Strattice Perforated had higher maximum load (72.65 ± 41.44 N/cm vs. 10.23 ± 4.67 N/cm, p < 0.05) and maximum stress (4.08 ± 2.08 Mpa vs. 0.44 ± 0.19 p < 0.05) than SurgiMend Microperforated. Maximum load retention rates following implantation were higher for Strattice Firm versus SurgiMend 1.0 (37.85% vs. 8.03%), Strattice Extra Thick versus SurgiMend 3.0 (45.03% vs. 37.80%), and Strattice Perforated versus SurgiMend Microperforated (28.04% vs. 6.21%). Similar results were obtained for maximum stress and stiffness. In conclusion, Strattice retained greater mechanical strength in vitro and in vivo, while exhibiting greater fibroblast cell infiltration. Impact statement Acellular dermal matrix (ADM)-derived surgical meshes are used in abdominal wall reconstruction procedures, such as hernia repair. Comparative studies evaluating the mechanical properties of ADMs and how they integrate with host tissue are essential because these properties impact performance in a clinical setting. This study compared the maintenance of mechanical integrity and host tissue biologic response of two commercially available ADMs, Strattice and SurgiMend, using in vitro and in vivo techniques. A better understanding of the properties of ADMs is expected to impact mesh selection and help to minimize the incidence of herniation recurrence and need for revisional surgery.
A Comparison of Acellular Dermal Matrices in Abdominal Wall Reconstruction. [2022]There is a growing literature of evidence that the use of acellular dermal matrices (ADMs) in abdominal wall reconstruction (AWR) for high-risk patients provides superior complication profiles when compared with standard synthetic mesh. Here we compare Fortiva, Strattice, and Alloderm ADMs in AWR.