Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Public ClinicalTrials.gov record NCT02147288. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02147288
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2011
- Primary completion
- May 31, 2014
- Completion
- May 31, 2014
- Last update posted
- Jan 29, 2017
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02147288, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2017 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02147288 live on ClinicalTrials.gov.