CiNPT for Abdominoplasties in Post-bariatric Patients Study

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.

Conditions

• Obesity, Morbid
• Obesity
• Obesity, Abdominal
• Wound
• Wound Infection
• Wound Complication
• Wound Dehiscence
• Wound Contamination
• Wound Heal
• Wound; Abdomen
• Incision
• Incision Site Rash
• Incision Site Bleeding
• Incision Site Swelling
• Incision Site Haematoma
• Incision Site Infection
• Incision Site Inflammation
• Incision Site Complication
• Incision Surgical
• Surgery--Complications
• Surgical Wound Infection
• Surgical Site Infection
• Scarring as Surgical Complication
• Scar
• Scarring

Interventions

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.

Sponsors & Collaborators

• Acelity

  collaborator OTHER

• Azienda Ospedaliera, Ospedale Civile di Legnano

  lead OTHER

Principal Investigators

• Silvio Abatangelo, M.D. · ASST Ovest Milanese

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-01

Primary Completion

2022-11-01

Completion

2023-01-31

FDA Device

Yes