Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Completed · Not applicable
Conditions studied: Seroma, Wound Dehiscence, Wound Infection
In brief
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.
Key facts
- Study ID
- NCT02147288
- Run by
- Yale University
- People needed
- 46
- Starts
- 2012-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2017-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 30 total patients undergoing panniculectomy alone following massive weight loss
- 30 total patients undergoing formal abdominoplasty (including undermining of skin flaps, rectus fascia plication and liposuction) following massive weight loss
- 30 total non-massive weight loss patients undergoing formal lipo-abdominoplasty
- 30 total patients undergoing ventral hernia repair using acellular dermal matrix
- 30 total patients undergoing bilateral breast reconstruction using acellular dermal matrix with 30 breasts randomized to conventional closed suction (one breast left vs right) and 30 breasts randomized to continuous negative pressure devices (=60 breasts total)
You may not qualify if…
- presence of necrotic tissue
- untreated osteomyelitis
- malignancy (except terminal patients for quality of life issues)
- untreated malnutrition
- use on exposed arteries, veins, or organs
- use on non-enteric and unexplored fistulas Special precaution will be taken when using the NPWT device in patients on anticoagulants, exhibiting otherwise difficult hemostasis, or non-adherent patients.
Where it is running
- Yale University School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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