RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
NCT ID: NCT02228889
Last Updated: 2025-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2015-01-31
2025-03-27
Brief Summary
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Detailed Description
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Our goals in this study are:
1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
2. SECONDARY OUTCOMES
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
1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Strattice
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
Abdominal wall reconstruction with Strattice
Abdominal wall reconstruction using Strattice
Assess pain intensity at last office visit preoperatively
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference at last office visit preoperatively
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning at last office visit preoperatively
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life at last office visit preoperatively
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity postoperatively
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference postoperatively
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning postoperatively
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life postoperatively
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days postoperatively
Assess hernia recurrence at 30 days
Assess bulge at 30 days postoperatively
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days postoperatively
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperatively
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences 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
Strattice mesh
XenMatrix
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
Assess pain intensity at last office visit preoperatively
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference at last office visit preoperatively
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning at last office visit preoperatively
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life at last office visit preoperatively
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity postoperatively
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference postoperatively
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning postoperatively
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life postoperatively
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days postoperatively
Assess hernia recurrence at 30 days
Assess bulge at 30 days postoperatively
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days postoperatively
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperatively
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences 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
Abdominal wall reconstruction with XenMatrix
Abdominal wall reconstruction with XenMatrix
XenMatrix
Xenmatrix mesh
Interventions
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Abdominal wall reconstruction with Strattice
Abdominal wall reconstruction using Strattice
Assess pain intensity at last office visit preoperatively
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference at last office visit preoperatively
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning at last office visit preoperatively
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life at last office visit preoperatively
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity postoperatively
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference postoperatively
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning postoperatively
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life postoperatively
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days postoperatively
Assess hernia recurrence at 30 days
Assess bulge at 30 days postoperatively
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days postoperatively
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperatively
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences 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
Abdominal wall reconstruction with XenMatrix
Abdominal wall reconstruction with XenMatrix
Strattice
Strattice mesh
XenMatrix
Xenmatrix mesh
Eligibility Criteria
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Inclusion Criteria
* Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
* Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
* Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Exclusion Criteria
* Active smokers (within the past 4 weeks) presenting for elective hernia repair
* Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
* Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
* Patients with severe systemic sepsis
* Patients with frank purulence in the wound
18 Years
99 Years
ALL
No
Sponsors
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Jeffrey Janis
OTHER
Responsible Party
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Jeffrey Janis
Professor of Plastic Surgery, Vice-Chairman
Principal Investigators
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Jeffrey E Janis, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2014H0041
Identifier Type: -
Identifier Source: org_study_id
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