Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION (POSITION)

February 1, 2024 updated by: Dimitrios Haidopoulos, National and Kapodistrian University of Athens

A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients

The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.

Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.

Study Type

Interventional

Enrollment (Actual)

200

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

  • Greece
    • Attika
      • Athens, Attika, Greece, 11528
        • Alexandra Hospital

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

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer

Exclusion Criteria:

Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases

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: Surgical drain
In this arm participants a surgical drain (Redon type) will be inserted above the abdominal fascia prior to suture of the subcutaneous tissue and of the skin
Procedure: Surgical drain
In this arm a surgical drain will be inserted prior to surgical wound closure
No Intervention: Control
In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of surgical site infection
Time Frame: Within 30 days
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Within 30 days
Risk of surgical debridement of surgical site infection
Time Frame: Within 30 days
Rates of surgical intervention to treat surgical site infection will be recorded
Within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of wound dehiscence
Time Frame: Within 30 days
Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded
Within 30 days
Length and depth of wound dehiscence
Time Frame: Within 30 days
In case of wound dehiscence the length and depth will be measured in cm
Within 30 days
Risk of seroma formation
Time Frame: Within 30 days
Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded.
Within 30 days
Risk and duration of fever related to surgical site infection
Time Frame: Within 30 days
Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius
Within 30 days
Duration of antibiotic therapy directed against surgical site infection
Time Frame: Within 30 days
The duration of post-operative use of antibiotics will be recorded in days
Within 30 days
Duration of hospitalization
Time Frame: Within 30 days
Duration of hospitalization will be recorded in days
Within 30 days
Re-admission rates
Time Frame: Within 30 days
Re-admission rates within 30 days will be reported
Within 30 days
Interval to adjuvant therapy
Time Frame: Within 30 days
The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days
Within 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3-year
3-year survival rate
3-year
Overall survival
Time Frame: 5-year
5-year survival rate
5-year

Collaborators and Investigators

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

Sponsor

National and Kapodistrian University of Athens

Collaborators

Aristotle University Of Thessaloniki
Saint Savvas Anticancer Hospital
Metaxa Hospital

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)

January 1, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 699/8-11-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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