Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04214236
Status:
UNKNOWN
Last Update Posted:
2020-01-02
First Post:
2019-12-20
Brief Title:
CiNPT for Abdominoplasties in Post-bariatric Patients Study
Sponsor:
Azienda Ospedaliera Ospedale Civile di Legnano
Organization:
Azienda Ospedaliera Ospedale Civile di Legnano
Study Overview
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:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPS
Brief 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
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 impaireddelayed 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-operativepost-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
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 impaireddelayed 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-operativepost-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None