Porcine Acellular Dermal Matrices for Hernia Repair
Palo Alto (17 mi)Overseen byJeffrey E Janis, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Jeffrey E Janis, MD
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Is Strattice, XenMatrix a promising treatment for hernia repair?Yes, Strattice and XenMatrix, which are made from pig tissues, are promising treatments for hernia repair. They are effective in replacing damaged tissue and are widely used in surgeries. They are also known for being safe and having minimal risk of causing immune reactions.1451013
What safety data is available for porcine acellular dermal matrices used in hernia repair?The safety data for porcine acellular dermal matrices, such as Strattice and XenMatrix, includes studies on their use in various medical applications. One study analyzed the performance of Strattice in complex abdominal wall reconstruction in intermediate-risk patients, reporting complications like seroma (7.3%), wound dehiscence with Strattice exposure (4.9%), cellulitis (2.4%), and hematoma (2.4%). However, all patients achieved successful abdominal wall closure without recurrent hernias or the need for Strattice removal. Another study compared antibiotic-coated and uncoated porcine dermal matrices in a rabbit model, focusing on antimicrobial performance. Additional research examined the remodeling of non-crosslinked acellular dermal matrices in a rabbit model of ventral hernia repair, and the retention of structural integrity in a primate model, which supports tissue remodeling. These studies suggest that porcine acellular dermal matrices can be used safely in hernia repair, with manageable complications and successful outcomes in complex cases.267910
What data supports the idea that Porcine Acellular Dermal Matrices for Hernia Repair is an effective treatment?The available research does not provide any data on Porcine Acellular Dermal Matrices for Hernia Repair. The studies listed focus on different treatments and conditions, such as radiotherapy techniques for cancer, and do not include information relevant to hernia repair or the effectiveness of Porcine Acellular Dermal Matrices.38111214
Do I have to stop taking my current medications for this trial?The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your doctor for guidance.
Eligibility Criteria
Adults over 18 needing elective hernia repair or abdominal wall tumor resection, who can't use synthetic mesh due to health issues or contamination. They should be in good health without severe heart, lung, kidney, or blood diseases and not in an emergency situation like bowel strangulation.Inclusion Criteria
I am older than 18 years.
I am having elective hernia repair, have a VHWG grade 2 or higher, and cannot use synthetic mesh due to other health issues or contamination.
I am considered fit for surgery and do not have severe heart, lung, kidney, or blood diseases.
I need a special mesh for closing a large abdominal tumor surgery wound.
Exclusion Criteria
I do not have severe heart, lung, kidney, or blood diseases and am seeking elective hernia repair.
I am here for an urgent hernia repair.
I do not have a severe infection throughout my body.
My wound is oozing pus.
Treatment Details
The trial is comparing two FDA-approved biologic meshes (Strattice and XenMatrix) used for hernia repairs and abdominal reconstructions. These meshes are made from pig skin that's been treated to remove cells and sterilized but produced by different companies.
2Treatment groups
Experimental Treatment
Group I: XenMatrixExperimental Treatment18 Interventions
Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
Group II: StratticeExperimental Treatment18 Interventions
Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
Strattice is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Strattice for:
- Ventral hernia repair
- Soft tissue reinforcement
- Body wall defects
🇪🇺 Approved in European Union as Strattice for:
- Ventral hernia repair
- Soft tissue reinforcement
- Body wall defects
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Ohio State University Wexner Medical CenterColumbus, OH
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Who is running the clinical trial?
Jeffrey E Janis, MDLead Sponsor
Jeffrey JanisLead Sponsor
References
A comparison of human and porcine acellularized dermis: interactions with human fibroblasts in vitro. [2022]Dermal substitutes derived from xenograft materials require elaborate processing at a considerable cost. Acellularized porcine dermis is a readily available material associated with minimal immunogenicity. The objective of this study was to evaluate acellularized pig dermis as a scaffold for human fibroblasts.
Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. [2022]Suboptimal clinical outcome following the implantation of porcine-derived tissue matrices may be due to the method of processing the material to achieve an acellular graft and to reduce the immune response to xenogeneic epitopes. The ability to produce a porcine-based graft material that retains the structural integrity of the extracellular matrix and minimizes the potential antigenic response to the galactose-alpha(1,3)-galactose terminal disaccharide (alpha-Gal) may allow the scaffold to support regeneration of native tissue.
Volumetric modulation arc radiotherapy compared with static gantry intensity-modulated radiotherapy for malignant pleural mesothelioma tumor: a feasibility study. [2019]A planning study was performed to evaluate RapidArc (RA), a volumetric modulated arc technique, on malignant pleural mesothelioma. The benchmark was conventional fixed-field intensity-modulated radiotherapy (IMRT).
Evaluation of human acellular dermis versus porcine acellular dermis in an in vivo model for incisional hernia repair. [2022]Incisional hernias commonly occur following abdominal wall surgery. Human acellular dermal matrices (HADM) are widely used in abdominal wall defect repair. Xenograft acellular dermal matrices, particularly those made from porcine tissues (PADM), have recently experienced increased usage. The purpose of this study was to compare the effectiveness of HADM and PADM in the repair of incisional abdominal wall hernias in a rabbit model. A review from earlier work of differences between human allograft acellular dermal matrices (HADM) and porcine xenograft acellular dermal matrices (PADM) demonstrated significant differences (P
Complete horizontal skin cell resurfacing and delayed vertical cell infiltration into porcine reconstructive tissue matrix compared to bovine collagen matrix and human dermis. [2021]Xenogenous dermal matrices are used for hernia repair and breast reconstruction. Full-thickness skin replacement is needed after burn or degloving injuries with exposure of tendons or bones. The authors used a human skin organ culture model to study whether porcine reconstructive tissue matrix (Strattice) is effective as a dermal tissue replacement.
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.
Porcine-derived acellular dermal matrix in primary augmentation mammoplasty to minimize implant-related complications and achieve an internal mastopexy: a case series. [2021]Patients who present for augmentation mammoplasty with poor quality mammary soft-tissue support may be at increased risk for post-operative complications. Non-crosslinked intact porcine-derived acellular dermal matrix (Strattice™ Reconstructive Tissue Matrix, LifeCell Corp., Branchburg, NJ, USA) may enhance soft-tissue support in such patients and reduce implant-related complications, including capsular contracture, rippling, palpability, and malposition. The objective of this case report series was to describe the outcomes of three patients with poor quality mammary soft-tissue support who underwent primary cosmetic breast augmentation with pre-emptive implantation of porcine-derived acellular dermal matrix.
Planning study to compare dynamic and rapid arc techniques for postprostatectomy radiotherapy of prostate cancer. [2021]To compare our standard technique for postprostatectomy radiotherapy of prostate cancer, i.e. using two lateral conformal dynamic arcs with volumetric-modulated arc therapy (VMAT) performed with the RapidArc(®) (Varian Medical Systems, Palo Alto, CA, USA). The plans were referred to as DA and RA, respectively.
Remodeling of Noncrosslinked Acellular Dermal Matrices in a Rabbit Model of Ventral Hernia Repair. [2016]Bioprostheses represent a significant advance in the abdominal wall reconstruction since they become degraded until their complete elimination in the recipient organism. This study examines remodeling in the host of three noncrosslinked porcine dermal collagen biomeshes: Strattice™ (St; LifeCell Corp.), XCM Biologic® Tissue Matrix (XCM; Synthes CMF) and Protexa® (Pr; Deco Med S.R.L.).
Comparison of Antibiotic-Coated versus Uncoated Porcine Dermal Matrix. [2022]The objective of this study was to evaluate the antimicrobial performance of a rifampin/minocycline-coated, non-cross-linked, acellular porcine dermal matrix (XenMatrix AB) compared to an uncoated, non-cross-linked, acellular porcine dermal matrix (Strattice) after implantation/inoculation with methicillin-resistant Staphylococcus aureus or Escherichia coli in a dorsal rabbit model.
SU-E-T-609: Improving the Efficiency of VMAT Plan Optimization by Using Sparse Decomposition Method. [2019]Volumetric modulated arc therapy (VMAT) is capable of delivering highly conformable dose distribution efficiently. Its planning is, however, more computationally intensive and requires a huge amount of memory space for optimization. We present an efficient sparse decomposition method for VMAT plan optimization.
Dosimetric comparison of RapidPlan and manually optimized plans in volumetric modulated arc therapy for prostate cancer. [2018]This study evaluated whether RapidPlan based plans (RP plans) created by a single optimization, are usable in volumetric modulated arc therapy (VMAT) for patients with prostate cancer.
The Comparison of Strattice and SurgiMend in Acellular Dermal Matrix-Assisted, Implant-Based Immediate Breast Reconstruction. [2021]Strattice (porcine derivative) and SurgiMend (bovine derivative) are the two most common acellular dermal matrices used in breast reconstruction in the United Kingdom. This retrospective study compared clinical outcomes in immediate implant-based breast reconstruction patients.
A Dosimetric Comparison of Lattice, Brass, and Proton Grid Therapy Treatment Plans. [2022]Our purpose was to dosimetrically compare volumetric modulated arc therapy (VMAT) lattice radiation therapy (LRT), brass, and proton grid therapy planning techniques and suggest potential clinical applications for each.