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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.
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).
Our goals in this study are:
i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strattice | Experimental | 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 |
|
| XenMatrix | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal wall reconstruction with Strattice | Procedure | Abdominal wall reconstruction using Strattice |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Surgical Site Occurrences (SSOs) at 6 Week | Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:
| 6 week postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey E Janis, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41720620 | Derived | Elemosho A, Sarac BA, Olson MA, Khansa I, Hackenberger PN, Narula V, Eiferman DS, Janis JE. Comparative Outcomes of Two Non-Crosslinked Porcine Acellular Dermal Matrices in Complex Abdominal Wall Reconstruction: A Randomized Controlled Trial and an Observational Cohort Study. World J Surg. 2026 Apr;50(4):848-859. doi: 10.1002/wjs.70271. Epub 2026 Feb 20. |
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There were no significant events in the study. Enrollment was stopped prior to the pre-determined 70 total participants, as a shift in practice and national trend toward the use of synthetic mesh over biologic mesh hindered participant recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Strattice | Abdominal wall reconstruction with Strattice 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2024 | Apr 28, 2025 |
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Abdominal wall reconstruction using Strattice
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| Assess pain intensity at last office visit preoperatively | Other | Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively) |
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| Assess pain interference at last office visit preoperatively | Other | Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively) |
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| Assess physical functioning at last office visit preoperatively | Other | Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively) |
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| Assess patient quality of life at last office visit preoperatively | Other | Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively) |
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| Assess patient pain intensity postoperatively | Other | Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey |
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| Assess pain interference postoperatively | Other | Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey |
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| Assess physical functioning postoperatively | Other | Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey |
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| Assess quality of life postoperatively | Other | Assess quality of life at 1 year postoperatively using the HerQLes survey |
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| Assess hernia recurrence at 30 days postoperatively | Other | Assess hernia recurrence at 30 days |
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| Assess bulge at 30 days postoperatively | Other | Assess bulge at 30 days |
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| Assess Surgical Site Occurrences at 30 days postoperatively | Other | Assess Surgical Site Occurrences at 30 days |
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| Assess hernia recurrence at 1 year postoperatively | Other | Assess hernia recurrence at 1 year postoperatively |
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| Assess bulge at 1 year postoperatively | Other | Assess bulge at 1 year postoperatively |
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| Assess Surgical Site Occurrences at 1 year postoperatively | Other | Assess Surgical Site Occurrences at 1 year postoperatively |
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| Assess overall complications at 30 days postoperatively | Other |
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| Assess overall complications at 1 year postoperatively | Other |
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| Abdominal wall reconstruction with XenMatrix | Procedure | Abdominal wall reconstruction with XenMatrix |
|
| Strattice | Device | Strattice mesh |
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| XenMatrix | Device | Xenmatrix mesh |
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| FG001 | XenMatrix | Abdominal wall reconstruction with XenMatrix 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 |
| COMPLETED |
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| NOT COMPLETED |
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Enrollment was stopped prior to the pre-determined 70 total participants, as a shift in practice and national trend toward the use of synthetic mesh over biologic mesh hindered participant recruitment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Strattice | Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis |
| BG001 | XenMatrix | Assess Bulge Assess Surgical Site Occurrences at 6 weeks Assess Recurrence Assess Seroma Assess Hematoma Assess Infection Assess Dehiscence Assess Skin necrosis |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Number of prior Hernia Repairs | Median | Inter-Quartile Range | prior repairs |
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| Hernia Width | Median | Inter-Quartile Range | cm |
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| Diabetes | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| COPD | Count of Participants | Participants |
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| Immunosuppression | Count of Participants | Participants |
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| Previous Hernia Repair | Count of Participants | Participants |
| ||||||||||||||||
| ASA Class | Participants are clinically graded using the ASA Physical Status Classification System, based on their overall health status and systemic disease burden at the time of surgery. Lower grades correlate to better outcomes. Stages I-II are better outcomes with Stages III-V are worse outcomes. lower ASA classes (I-II) are associated with better surgical outcomes, while higher classes (III-V) indicate increased risk of complications. This staging reflects overall health and is used both clinically and in research to stratify risk. | Count of Participants | Participants | No |
| ||||||||||||||
| Ventral Hernia Working Group | VHWG grading system categorizes patients based on the risk of surgical site occurrences (SSOs) and wound complications during ventral hernia repair. It incorporates host comorbidities, wound condition, and presence of infection. Grades 1-2 correlate with better outcomes, Grades 3-4 are worse outcomes. VHWG Grades 1-2 are associated with favorable surgical outcomes, while Grades 3-4 represent higher-risk patients with significantly increased complication rates due to infection or contamination. | Count of Participants | Participants | No |
| ||||||||||||||
| Kanters Grade | Kanters Grade categorizes patients based on the severity and complexity of the hernia and overall health. This helps predict the risk of complications, wound infections and hernia recurrence. Grade 1-2 are correlated with better outcomes and Grade 3-4 are worse outcomes. Grades 1 and 2 are associated with better outcomes, such as lower complication rates, quicker recovery, and the ability to use synthetic mesh. Kanters Grades 3 and 4 represent more complex hernias with higher complication risks, including infection, need for biologic mesh, longer recovery times, and higher recurrence rates | Count of Participants | Participants | No |
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| Primary Fascial Repair | Count of Participants | Participants |
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| Unilateral Component Separation | Count of Participants | Participants |
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| Bridged Repair | Count of Participants | Participants |
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| Total OR Time | Median | Inter-Quartile Range | minutes |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Surgical Site Occurrences (SSOs) at 6 Week | Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:
| participants who got to 6 weeks | Posted | Mean | Standard Error | event | 6 week postoperatively |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strattice | Infections: Infections at the surgical site or throughout the body are a potential risk. Seromas: Fluid collections (seromas) can form at the surgical site. Wound Healing Problems: Necrosis (tissue death) or impaired wound healing can occur. Wound Dehiscence: The wound may reopen. Implant Exposure: In some cases, the breast implant may become exposed. Hematoma: Blood clots can form at the surgical site. Erythema: Redness or inflammation of the skin. Explantation: In some cases, the implant may need to be removed (explanted). Re-implantation of an expander: In some cases, a breast expander may need to be re-implanted. Salvage procedures: In some cases, additional procedures may be needed to address complications. Implant Loss: In rare cases, the implant may be lost. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | XenMatrix | Allergic Reactions: Hypersensitivity to porcine products or tetracyclines/rifamycins is a contraindication for using XenMatrix. Seroma: A collection of fluid under the skin or tissue. Infection: The surgical site or the graft itself can become infected. Inflammation: Swelling and redness around the surgical area. Adhesion: Scar tissue forming between tissues or organs. Fistula formation: An abnormal connection or passage between two organs or tissues. Erosion: Wearing away or breakdown of the tissue. Hematoma: A collection of blood outside of a blood vessel. Recurrence of the tissue defect: The hernia or tissue defect returns after surgery. Wound Dehiscence: The wound opening up after surgery. Hernia Recurrence: The hernia returns after surgery. | 0 | 30 | 0 | 30 | 0 | 30 |
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The study was completed prior to the anticipated 70 total participants, as new data and literature have shifted a national trend away from the use of biologic mesh and toward synthetic mesh, which significantly impeded recruitment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Janis | The Ohio State University Wexner Medical Center | (614) 297-2913 | jeffrey.janis@osumc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 18, 2025 | Apr 28, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2022 | Apr 28, 2025 | ICF_002.pdf |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D007412 | Intestinal Fistula |
| D018221 | Fibromatosis, Abdominal |
| D006547 | Hernia |
| D010534 | Peritoneal Neoplasms |
| D018222 | Desmoid Tumors |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D005402 | Fistula |
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D004067 | Digestive System Neoplasms |
| D010532 | Peritoneal Diseases |
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| ID | Term |
|---|---|
| D061645 | Abdominoplasty |
| C568444 | strattice |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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