Evaluation of ciNPT Effects on Healing and Post-surgical Complications in High-risk Post- Bariatric Patients Undergoing Body-contouring Abdominoplasty: a Monocentric Prospective RCT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- Rate of post-surgical local complications
研究概览
简要总结
The overarching goal of this research is to assess whether the post-operative use of closed-incision Negative Pressure Therapy (ciNPT) accelerates healing of surgical wounds, improves surgical outcomes, and reduces the rate of local complications in high-risk, obese, post-bariatric patients undergoing abdominal body-contouring procedures (abdominal panniculectomy or "abdominoplasty") compared to standard wound care.
The investigators postulate that ciNPT can cost-effectively improve outcomes and standard of post-surgical care in this specific category of patients.
This hypothesis will be tested through a prospective, interventional, case-control, randomized clinical trial.
详细描述
In the United States (US) 37% of the adult population is obese and 5% is considered morbidly obese. Similar trends have been observed in Europe and more recently in Asia. A large number of obese patients seeks treatment through bariatric surgery or diet-lifestyle changes. The resulting massive loss of weight leaves patients with an excess cutaneous tissue, requiring body-contouring procedures.
In the US 85% of post-bariatric patients seek body-contouring surgeries. Due to systemic and local factors, these procedures show a rate of local complications as high as 68-80%, significantly prolonging hospitalization and increasing treatment-related costs.
Several clinical studies have shown that external suction (Closed Incision Negative-Pressure Therapy, ciNPT) can accelerate closure of surgical wounds in patients at high-risk for impaired/delayed healing and can significantly reduce the rate of local complications. The investigators believe that ciNPT might significantly decrease the rate of minor local complications in post-bariatric patients undergoing body-contouring procedures, and that this strategy could represent a cost-effective adjuvant treatment in body-contouring procedures.
The investigators' preliminary study experience on post-bariatric obese patients undergoing an abdominoplasty and post-operatively treated with ciNPT, showed that ciNPT promotes effective and prompt wound closure minimizing peri-operative/post-operative complications in these patients. The investigators also showed that ciPNT positively impacts the length of hospitalization and the rate of secondary surgeries in these patients.
Based on this successful preliminary experience, the invetsigators here propose to validate these findings in a prospective RCT.
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
- Single (Outcomes Assessor)
盲法说明
Analysis of data and statistical analysis will be blinded to groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •previous bariatric surgery for weight loss
- •candidate for/undergoing an abdominal panniculectomy (abdominoplasty)
- •Residual BMI >30 kg/m2 at the time of the operation
- •Evidence of pannus (abdominal) ptosis (Pittsburgh Rating Scale >2)
- •Lipodystrophy and inelasticity of the skin
- •Presence at the time of surgery of at least one local risk factor (e.g. a history or the presence of local complications such as skin blistering, recurrent erythema, panniculitis, or chronic infection; history of abdominal hernia or need for abdominal hernia repair) OR one systemic risk factor (diabetes, smoking habit, serum proteins below 6g/dL).
排除标准
- •Severe systemic co-morbidities (defined as ASA III or higher)
- •Malignant tumors
- •Conditions or medications affecting wound healing (e.g. steroidal drugs or keloids)
- •Known allergies to components of the treatment
- •Presence of severe local cutaneous complications (open wounds, extensive infections) at the time of surgery.
结局指标
主要结局
Rate of post-surgical local complications
时间窗: 30 days
The change in post-surgical local complications (Skin blistering/necrosis, Surgical Site Infections, hematoma, seroma, need for re-operation) through 30 days after surgery.
次要结局
- Scar quality: Vancouver Scar Scale(30 and 90 days)
- Time-to-heal(<60 days)
- Medical costs(60 days)
研究者
Silvio Abatangelo
Plastic Surgeon - Physician
Azienda Ospedaliera, Ospedale Civile di Legnano