Trials / Unknown

UnknownNCT04214236

CiNPT for Abdominoplasties in Post-bariatric Patients Study

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: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 130 (estimated)

Sponsor: Azienda Ospedaliera, Ospedale Civile di Legnano · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
DEVICE	ciNPT group	Closed-incision negative pressure therapy (ciNPT) will be applied for 7 day using continuous suction at 125 mmHg. To deliver ciNPT we will use a commercially available, FDA-approved device, used according to the manufacturer' indications (PREVENA™ Incision Management System (KCI, San Antonio, Texas, USA). After the first 7 post-operative days, subjects will discontinue the ciNPT and follow a standard wound care protocol.
OTHER	Control group	Standard non-adherent surgical dressing (Vaseline petrolatum gauze) will be used for management of incisional wounds in the control group. Dressing changes will be performed per standard wound care protocol.

Timeline

Start date: 2020-02-01
Primary completion: 2022-11-01
Completion: 2023-01-31
First posted: 2020-01-02
Last updated: 2020-01-02

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT04214236. Inclusion in this directory is not an endorsement.