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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: Completed NA study, sponsored by Yale University.
NCT02147288 is a NA study that has completed, run by Yale University. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)
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 |
What the finished NCT02147288 record still lists
NCT02147288 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Renasys*GO Negative Pressure Wound Therapy System is the first listed.
NCT02147288 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02147288's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 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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