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NCT01794338 · ClinicalTrials.gov registry record · NA
The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients
A NA study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT01794338: Clinical Trial NA study, sponsored by Wake Forest University Health Sciences.
NCT01794338 is a NA study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01794338, a NA study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provide durable long-term outcomes; however, this type of mesh should not be used in patients at risk of developing an infection. Therefore, to address the challenge of finding an artificial strengthening material to repair complicated hernias in patients that could potentially develop surgical infection, two types of non-permanent materials have been developed, including biologics and bioabsorbables. Biologic mesh is made of living tissue and bioabsorbable mesh is made of synthetic material that is gradually absorbed by the body over time. The purpose of this study is to allow surgeons to compare the postoperative course of patients associated with these two mesh types to decide which material will improve the outcomes of their patients with complicated abdominal wall defects. To date there is no evidence to suggest that either mesh type is superior or safer than the other.
Primary Outcome
Patients will undergo post-operative follow-up at 1 month, 6 months, and yearly for 3 years. Patients will receive reminders of their follow-up visits before each time period. At each visit, patients will be asked to fill out a short questionnaire (Form A and Form B) that will aid in assessing and documenting postoperative symptoms and quality of life. During each follow-up visit a board certified or board eligible surgeon, who is blinded with regard to the group assignment, will perform a physi
Interventions
- DEVICE Strattice Arm
- DEVICE Bio-A Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-11 |
| Est. Completion | 2017-07-21 |
| Phase | NA |
Why NCT01794338 stopped before completion
NCT01794338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Strattice Arm is the first listed.
NCT01794338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01794338 about?
NCT01794338 is a clinical study titled "The Use of Biologic Mesh vs Bioabsorbable Mesh During Ventral Hernia Repair in At-risk Patients". This study evaluates the outcomes of patients who have been treated with Strattice or Gore Bio-A mesh for the repair of complicated abdominal wall hernias. The purpose of this study is to collect information and evaluate the outcome of your surgery. Synthetic (man made) mesh has been shown to provid...
What is the current status of trial NCT01794338?
This trial is currently terminated. It is a NA study. The enrollment target is 28 participants. The study started on 2012-11. Estimated completion is 2017-07-21.
What interventions are being tested in trial NCT01794338?
The interventions under investigation include: Strattice Arm (DEVICE), Bio-A Arm (DEVICE).
Who is sponsoring clinical trial NCT01794338?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01794338's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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