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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 is a NA study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants.

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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.

Interventions

  • DEVICE Strattice Arm
  • DEVICE Bio-A Arm

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2012-11
Est. Completion 2017-07-21
Phase NA

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT01794338

The ClinicalTrials.gov registry entry for NCT01794338 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Strattice Arm is the first listed.

NCT01794338 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.