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NCT02147288 · ClinicalTrials.gov registry record · NA
Prevention of Seroma Formation and Wound Complications Using NPWT Devices
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT02147288 is a NA study that has completed, run by Yale University. The registered enrollment target is 46 participants.
The verdict
NCT02147288, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus. Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty. Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care. Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.
Interventions
- DEVICE Renasys*GO Negative Pressure Wound Therapy System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02147288
The ClinicalTrials.gov registry entry for NCT02147288 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Renasys*GO Negative Pressure Wound Therapy System is the first listed.
NCT02147288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02147288 about?
NCT02147288 is a clinical study titled "Prevention of Seroma Formation and Wound Complications Using NPWT Devices". The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral herni...
What is the current status of trial NCT02147288?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2012-01. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02147288?
The interventions under investigation include: Renasys*GO Negative Pressure Wound Therapy System (DEVICE).
Who is sponsoring clinical trial NCT02147288?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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