Clinical Trial: Prevention of Seroma Formation and Wound Complications Using NPWT Devices

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prevention of Seroma Formation and Wound Complications Using NPWT Devices

Brief 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 t

Detailed Summary:

In collaboration with the Yale Bariatric Surgery Program and General Surgery Department, patients will be identified as 18-years-of-age or older seeking body-contouring procedures (including panniculectomy and abdominoplasty) following massive weight loss or those patients in need of complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction necessitating the use of acellular dermal matrix. For the timeframe outlined in this protocol, the Section of Plastic Surgery at Yale performs surgeries in excess of the required numbers needed for this study, ensuring timely completion.

Exclusion criteria will include the FDA-identified contraindications to use of continuous negative pressure suction devices, as follows:

  • 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.

Following a detailed explanation of the study design as well as the associated risks and benefits that may be incurred by each potential test group, patients who agree to participate in the study (via informed consent) will be categorized by characteristics including past medical history, past surgical history, social history, pre- and post-bariatric surgery total weight loss and BMI and will be randomized into either the control (standard closed s
Sponsor: Yale University

Current Primary Outcome: Post-operative Seroma Formation [ Time Frame: Two weeks following drain removal ]

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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: May 21, 2014
Date Started: January 2012
Date Completion:
Last Updated: December 6, 2016
Last Verified: December 2016