Prevention of Seroma Formation and Wound Complications Using NPWT Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Post-operative Seroma Formation
研究概览
简要总结
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.
详细描述
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 suction drains) or experimental (continuous negative pressure via NPWT device) arm of each group, depending on the procedure to be performed, as follows:
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Post-operative Seroma Formation
时间窗: 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)
次要结局
未报告次要终点