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NCT01886963 · ClinicalTrials.gov registry record · NA
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 115
- Enrollment target
NCT01886963 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 115 participants.
The verdict
NCT01886963, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
Study Summary
The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs. Complex ventral hernia repairs are associated with a high rate of wound complications. To a large degree these complications are caused by creating tissue advancement flaps to close the abdomen, which can compromise the blood supply to the skin and subcutaneous tissues. The current standard of care for assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however, often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite System is a device that enables surgeons to visualize and evaluate tissue perfusion in real time. It can help the surgeon to identify optimal flap design and reduce the risk of postoperative wound complications related to tissue ischemia. The primary goal of this study is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite System has been used successfully for assessing the viability of mastectomy flaps in breast surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis. However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral hernia repairs.
Interventions
- DEVICE SPY - Unblinded use of SPY Elite
- DEVICE Control - Blinded use of SPY Elite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01886963
The ClinicalTrials.gov registry entry for NCT01886963 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 115 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 SPY - Unblinded use of SPY Elite is the first listed.
NCT01886963 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01886963 about?
NCT01886963 is a clinical study titled "A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair". The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs. Complex ventral hernia repairs are associated with a high rate of woun...
What is the current status of trial NCT01886963?
This trial is currently completed. It is a NA study. The enrollment target is 115 participants. The study started on 2011-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01886963?
The interventions under investigation include: SPY - Unblinded use of SPY Elite (DEVICE), Control - Blinded use of SPY Elite (DEVICE).
Who is sponsoring clinical trial NCT01886963?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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