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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |