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

October 10, 2020 updated by: Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Prophylactic Negative Pressure Wound Therapy in Gynecologic Oncology: a Prospective Controlled Randomized Trial. (GO-VAC)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Wound complications in patients undergoing surgery for malignancies have a negative impact on quality of life and, in addition, are associated with an increase of the duration of hospital stay, imparting a significant socio-economic burden.

Several approaches have been proposed to reduce the wound complications rate without success. Instead, a novel and promising method has been employed which utilizes prophylactic negative pressure wound therapy placed over clean and closed surgical incisions immediately after surgery (ciNPWT).

In a recent meta-analysis across studies including all types of wounds and surgeries, ciNPWT was observed to reduce by 29.4 % the incidence of SSI and the odds of SSI. In the same meta-analysis, while limiting attention to general abdominal surgery alone, the weighted average of the selected studies reported a reduction in wound complications of 10.43% (13.54% vs 23.97%) for the ciNPWT group compared with controls which was a significant benefit.

This study is a prospective multi-centre controlled randomized trial, where after gynecologic oncologic laparotomic surgery and standard abdominal wall closure (if inclusion criteria result satisfied), patient is randomized to one of the two arms of the study: ARM A (sperimental): ciNPWT ARM B ( control): standard dressing.

For women in arm A: prophylactic ciNPWT therapy entails placement of the device over a closed incision immediately post-operatively. The device may be left in place with no additional intervention for up to 7 days. The use of the device does not require specialty care services or continued hospitalization. For women in arm B: standard dressing should be changed every 2 days after sterile medication.

People will be visited after 7 day of VAC-therapy (first visit) , discharge time (second visit or coincidence with the first visit), after 15 days from surgery (third visit for agraphis removal), after 30 days from surgery (fourth visit).

Sample size determination. A review of previous literature suggests that the incidence of wound-SSI is about 35% in G.O. patients. We assume that the use of ciNPWT could be linked to an wound-SSI incidence of 15% Setting a two-sided α=0.05 and power = 80%, the sample size is N=164 subjects. A dropout rate of 20% is added, reaching a final sample size of N=196 subjects (98 subjects per arm).

The primary objective will be achieved calculating and comparing the proportions of wound-SSI in the two arms. The comparison will be performed with a Chi-squared test. The same test will be applied to the comparisons of final and intermediate wound healing rates. The comparison of the proportion of wound complications and the proportion of patients in need of antibiotics will be achieved with a Chi-squared test, as well. Comparison of the time of operating room required to apply the dressings, hospital stay and time to adjuvant therapies will be performed with a T-test (if data are normally distributed) or with the Wilcoxon test (if data are not normal). A p-value <0.05 will be considered statistically significant.

All patient data will be collected and managed using an electronic database anonymously.

Study Type

Interventional

Enrollment (Anticipated)

196

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 Locations

  • Italy
    • RM
      • Roma, RM, Italy
        • Fondazione Policlinico Universitario A. Gemelli, IRCCS

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

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All patients subjected to midline incision (xiphoid-pubic/sub-xiphoid/umbilical-pubic incision) with:

  • Moderate/Severe (Aletti score ≥3) Modified surgical complexity score in:

    • Ovarian cancer: primary debulking surgery (PDS) or interval debulking surgery (IDS) (minimum total hysterectomy+bilateral salpingo-oophorectomy+lymphadenectomy in early ovarian cancer [EOC] should be done to include the patient in the trial) or secondary debulking surgery at recurrence (SCS).
    • Endometrial cancer FIGO stage IV or staging surgery for high risk endometrial cancer
    • Uterine Sarcomas FIGO stage IIB-IV
    • Previous history of pelvic or abdominal radiotherapy (even locally advanced cervical cancer [LACC] post neoadjuvant (NAD) therapies [NAD chemo-radiation or chemotherapy alone])
    • Persistent or recurrent Cervical cancer
  • Obesity (>30 Kg/sqm) in all Aletti score surgery and in all FIGO stage malignancies
  • Controlled diabetes mellitus in all Aletti score surgery and all FIGO stage malignancies
  • Heavy smokers ≥ 20 cigarettes a day in all Aletti score surgery and all FIGO stage malignancies.

Exclusion Criteria:

  • uncontrolled diabetes mellitus
  • severe cardiac dysfunction
  • pregnancy
  • underweight (body mass index [BMI] < 18.5 kg/sqm)
  • long-term steroid use
  • subcutaneous (e.g. Jackson Pratt) drainage positioning
  • post-operative prophylactic use of antibiotics beyond the intraoperative short therapy
  • contaminated (class III) and dirty/infected (class IV) incision [10]
  • allergy to silver

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: VAC therapy
Prophylactic ciNPWT therapy positioning YES. Patients enrolled for placement of the device over a closed incision immediately post-operatively.
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.
NO_INTERVENTION: Standard Closure
Prophylactic ciNPWT therapy positioning NO. Patients enrolled for standard laparotomic closure without ciNPWT positioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the rate of surgical site infections at 15 days
Time Frame: 15 days
To investigate whether the application of an ciNPWT device (Prevena Incision Management System, KCI, Inc., San Antonio, TX, USA) change the rate of surgical site infections (SSI) within 15 postoperative days in gynecologic oncology patients undergoing surgery, from 35 % to 15 %.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complications at 30 days
Time Frame: 30 days
Evaluate, compare and describe wound complications through the systematic performing of surgical wound swab at 7, 15, 30 days after surgery
30 days
Change of the rate of surgical site infections at 7 days
Time Frame: 7 days
Evaluate and compare the wound healing rate at intermediate evaluation
7 days
Estimated operative time
Time Frame: 1 day
Evaluate and compare the time required for use of the operating room
1 day
Estimated hospital stay
Time Frame: 3-30 days
Evaluate and compare the duration of hospital stay
3-30 days
Antibiotic therapy estimate
Time Frame: 30 days
Evaluate and compare the proportions of patients requiring antibiotics because of wound complications
30 days
Time to start adjuvant therapy
Time Frame: 30-50 days
Evaluate and compare the time to eventual adjuvant therapies.
30-50 days

Collaborators and Investigators

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

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Giovanni Scambia, Professor, Fondazione Policlinico Universitario A. Gemelli, IRCCS,Rome

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.

General Publications

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 (ACTUAL)

September 18, 2020

Primary Completion (ANTICIPATED)

September 18, 2021

Study Completion (ANTICIPATED)

September 18, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (ACTUAL)

October 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 10, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G.O-VAC. ID. 3316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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