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Completed

NCT Number: NCT05179122

Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

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.

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Key information

Age range

30 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Alexandra Hospital

Athens, Attica, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical drain

Procedure

In this arm a surgical drain will be inserted prior to surgical wound closure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. Duration of hospitalization

    Time frame: Within 30 days

    Duration of hospitalization will be recorded in days

  7. Re-admission rates

    Time frame: Within 30 days

    Re-admission rates within 30 days will be reported

  8. Interval to adjuvant therapy

    Time frame: Within 30 days

    The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days

Other outcomes

  1. Overall survival

    Time frame: 3-year

    3-year survival rate

  2. Overall survival

    Time frame: 5-year

    5-year survival rate

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Metaxa Hospital
  • Saint Savvas Anticancer Hospital

Registry information

Official study title

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

Acronym: POSITION

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 5, 2022
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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