CiNPT for Abdominoplasties in Post-bariatric Patients Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Incision Site Complication
- Incision
- Surgery- Complications
- Obesity Morbid
- Wound
- Wound; Abdomen
- Surgical Site Infection
- Scar
- Incision Site Bleeding
- Scarring as Surgical Complication
- Wound Complication
- Incision Site Haematoma
- Incision Site Infection
- Incision Site Inflammation
- Incision Site Rash
- Scarring
- Incision Site Swelling
- Wound Dehiscence
- Wound Infection
- Surgical Wound Infection
- Wound Contamination
- Incision Surgical
- Wound Heal
- Obesity
- Obesity, Abdominal
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Case-control Experimental/Interventional Group: post-operative ciNPT (first 7 days) Control Group: post-operative standard wound careMasking: Single (Outcomes Assessor)Masking Description: Analysis of data and statistical analysis will be blinded to groups.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT04214236
- Collaborators
- Acelity
- Investigators
- Principal Investigator: Silvio Abatangelo, M.D. ASST Ovest Milanese
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