CiNPT for Abdominoplasties in Post-bariatric Patients Study (CAPS)

December 30, 2019 updated by: Silvio Abatangelo, Azienda Ospedaliera, Ospedale Civile di Legnano

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • previous bariatric surgery for weight loss
  • candidate for/undergoing an abdominal panniculectomy (abdominoplasty)
  • Residual BMI >30 kg/m2 at the time of the operation
  • Evidence of pannus (abdominal) ptosis (Pittsburgh Rating Scale >2)
  • Lipodystrophy and inelasticity of the skin
  • Presence at the time of surgery of at least one local risk factor (e.g. a history or the presence of local complications such as skin blistering, recurrent erythema, panniculitis, or chronic infection; history of abdominal hernia or need for abdominal hernia repair) OR one systemic risk factor (diabetes, smoking habit, serum proteins below 6g/dL).

Exclusion Criteria:

  • Severe systemic co-morbidities (defined as ASA III or higher)
  • Malignant tumors
  • Conditions or medications affecting wound healing (e.g. steroidal drugs or keloids)
  • Known allergies to components of the treatment
  • Presence of severe local cutaneous complications (open wounds, extensive infections) at the time of surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ciNPT group
Subjects will receive post-operative incisional wound care by ciNPT (125 mmHg, continuous suction) for the first 7 days after surgery.
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 Names:
  • ciNPT
  • PREVENA™ Incision Management System
  • closed-incision negative pressure therapy
Sham Comparator: Control group
Subjects will receive post-operative incisional wound care by standard non-adherent surgical dressing (vaseline petrolatum gauze),
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.
Other Names:
  • Standard incisional wound care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-surgical local complications
Time Frame: 30 days
The change in post-surgical local complications (Skin blistering/necrosis, Surgical Site Infections, hematoma, seroma, need for re-operation) through 30 days after surgery.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-heal
Time Frame: <60 days
A change in time (days) to complete wound closure for treated groups vs. controls.
<60 days
Scar quality: Vancouver Scar Scale
Time Frame: 30 and 90 days
A change in the macroscopic quality of scars at a 30 and 90 days follow up (measured with the Vancouver Scar Scale-VSS [Score range: 0-13, lower scores being a better outcome]).
30 and 90 days
Medical costs
Time Frame: 60 days
A change in direct medical costs (considering cumulative costs related to: hospitalization, standard and additional post-operative care, additional surgical and medical care for complications) in the first 60 days after surgery.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Silvio Abatangelo, M.D., ASST Ovest Milanese

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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