MedTrace Logo

Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.)

NCT04584957 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-10-14

No results posted yet for this study

Summary

A prospective controlled randomized study aimed to prospectively evaluate, the impact and effectiveness of clean incision prophylactic vacuum negative pressure therapy on wound healing (ciNPWT) in women at high risk of developing wound complications who undergo major gynecologic surgery.

Gynecologic Oncology patients appear to be more at risk of developing wound complications than the general surgery population, reaching infection rates of 36 vs. 24 % that become 40 and 60% for obese and morbidly obese patients, respectively. Data about the use of ciNPWT are few, controversial and are of poor quality. No randomized, controlled trials have yet been reported in support of the use of ciNPWT in the gynecologic population.

Conditions

  • Wound Infection
  • Gynecologic Cancer

Interventions

DEVICE

VAC therapy

Prophylactic ciNPWT therapy (Prevena® KCI) entails placement of the device over a closed incision immediately post-operatively. Prevena® KCI may be left in place with no additional intervention for up to 7 days.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Giovanni Scambia, Professor · Fondazione Policlinico Universitario A. Gemelli, IRCCS,Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2021-09-18
Completion
2021-09-18

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04584957 on ClinicalTrials.gov