Wound Infection Clinical Trial
Official title:
Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Verified date | May 2014 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 150 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | Smith & Nephew, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative Seroma Formation | 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) | Two weeks following drain removal | No |
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