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NCT02228889 · ClinicalTrials.gov registry record · NA
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
A NA study of Hernia, Ventral and Intestinal Fistula, sponsored by Jeffrey Janis.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT02228889: Completed NA study of Hernia, Ventral and Intestinal Fistula, sponsored by Jeffrey Janis.
NCT02228889 is a NA study of Hernia, Ventral and Intestinal Fistula that has completed, run by Jeffrey Janis. The registered enrollment target is 46 participants, below the 177-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228889, a NA study of Hernia, Ventral and Intestinal Fistula, has completed, sponsored by Jeffrey Janis.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include: 1. Infection 2. Seroma 3. Hematoma 4. Wound dehiscence 5. Skin necrosis 6. Formation of enterocutaneous fistula 7. Mesh infection
Conditions Studied
Interventions
- PROCEDURE Abdominal wall reconstruction with Strattice
- OTHER Assess pain intensity at last office visit preoperatively
- OTHER Assess pain interference at last office visit preoperatively
- OTHER Assess physical functioning at last office visit preoperatively
- OTHER Assess patient quality of life at last office visit preoperatively
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-01 |
| Est. Completion | 2025-03-27 |
| Phase | NA |
What the finished NCT02228889 record still lists
NCT02228889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 177-participant average among 7 other Hernia, Ventral trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Hernia, Ventral appearing as the primary indexed condition, and to 5 interventions - of which Abdominal wall reconstruction with Strattice is the first listed.
NCT02228889 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02228889 about?
NCT02228889 is a clinical study titled "RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction". 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. Th...
What is the current status of trial NCT02228889?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2015-01. Estimated completion is 2025-03-27.
What conditions does trial NCT02228889 study?
This clinical trial studies the following conditions: Hernia, Ventral, Intestinal Fistula, Fibromatosis, Abdominal.
What interventions are being tested in trial NCT02228889?
The interventions under investigation include: Abdominal wall reconstruction with Strattice (PROCEDURE), Assess pain intensity at last office visit preoperatively (OTHER), Assess pain interference at last office visit preoperatively (OTHER), Assess physical functioning at last office visit preoperatively (OTHER), Assess patient quality of life at last office visit preoperatively (OTHER).
Who is sponsoring clinical trial NCT02228889?
This trial is sponsored by Jeffrey Janis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02228889 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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