CiNPT for Abdominoplasties in Post-bariatric Patients Study — CAPS  

Obesity Clinical Trial

Official title: Evaluation of ciNPT Effects on Healing and Post-surgical Complications in High-risk Post- Bariatric Patients Undergoing Body-contouring Abdominoplasty: a Monocentric Prospective RCT

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Cicatrix
• Communicable Diseases
• Hematoma
• Incision
• Incision Site Bleeding
• Incision Site Complication
• Incision Site Haematoma
• Incision Site Infection
• Incision Site Inflammation
• Incision Site Rash
• Incision Site Swelling
• Incision Surgical
• Infection
• Inflammation
• Obesity
• Obesity, Abdominal
• Obesity, Morbid
• Scar
• Scarring
• Scarring as Surgical Complication
• Surgery--Complications
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound
• Wound Complication
• Wound Contamination
• Wound Dehiscence
• Wound Heal
• Wound Infection
• Wound; Abdomen
• Wounds and Injuries

• NCT number: NCT04214236
• Study type: Interventional
• Source: Azienda Ospedaliera, Ospedale Civile di Legnano
• Contact: Silvio Abatangelo, M.D.
• Phone: +39 (02) 97 96 3466
• Email: caps.trial@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Completion date: January 31, 2023