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NCT Number: NCT06780813

Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients

The incidence of surgical-site infection (SSI) and complications related to wound healing reaches 10-20% of gynecological cancer patients. Each complication may dramatically prolong the hospitalization period and increase the economic burden of hospital care. Appropriate wound care and tissue oxygenation are of special importance for wound healing. Assuming adequate perfusion, the easiest, safest, and most effective way to improve tissue oxygenation is to increase the fraction of inspired oxygen. However, there is considerable controversy as to whether supplemental oxygen actually reduces SSI and healing-related complications as to date, there is absence of relevant data.

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Key information

Conditions

Supplemental Oxygen Gynecological Cancer Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infections Surgical Wound Infection Wound Infection

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

First department of Obstetrics and Gynecology

Athens, 11528, Greece

Location status: Recruiting

Location contact

Vasilios Pergialiotis, Assistant Professor

CONTACT

[email protected]

+302132162291

About this study

This study aims to investigate the prophylactic value of postoperative oxygen administration against the development of wound infections in obese gynecological oncology patients undergoing laparotomy for the treatment of endometrial or ovarian cancer. At the same time, the factors that lead to an increase in this risk will be outlined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obese (BMI>30kg/m2) gynecological cancer patients
  • Optimized preoperative CBC values (hemoglobin >11g/dl, WBC 4.000-11.000 X 109/L, platelets 150,000 to 400,000 X 109/L)
  • In the case of neoadjuvant therapy an interval longer than three weeks between the last cycle and the operation

Exclusion criteria

  • Active immunosuppresion
  • Preexisting infection of the abdominal wall
  • Preexisting sepsis

Treatment and study plan

Supplemental oxygen therapy

Behavioral

In this grou participants will receive supplemental oxygen in the form of a Venturi mask upon low oxygen saturation in oximetry (SaO2<95%) and a nasal oxygen mask in all other cases during the first 2 postoperative days

Primary outcomes

  1. Surgical site infections

    Time frame: Within 30 days from the operation

    Surgical site infections will be evaluated using the Southampton wound scoring system

  2. Systemic inflammatory response syndrome

    Time frame: Within 30 days from the operation

    The proportion of patients developing SSI-related systemic inflammatory response will be documented

Secondary outcomes

  1. Need for surgical debridement

    Time frame: Within 30 days from the operation

    Need for surgical debridement (bedside or on the operation theatre)

  2. Seroma formation

    Time frame: Within 30 days from the operation

    The development of wound seroma will be recorded

  3. Wound hematoma

    Time frame: Within 30 days from the operation

    The formation of wound hematoma will be evaluated

  4. Uncomplicated wound healing

    Time frame: Within 30 days from the operation

    The proportion of patients with no apparent wound healing problems will be documented

  5. Additional wound assisting devices

    Time frame: Within 30 days from the operation

    The need for vacuum assisted wound healing will be documented

  6. Antibiotic coverage

    Time frame: Within 30 days from the operation

    The need for supplemental antibiotic coverage will be documented

  7. Multidrug resistant pathogens

    Time frame: Within 30 days from the operation

    The proportion of patients with multidrug-resistant pathogens involving SSI will be documented

  8. Duration of hospitalization

    Time frame: Within 30 days from the operation

    The total duration of hospitalization will be documented

  9. Hospital readmissions related to SSI

    Time frame: Within 30 days from the operation

    Readmissions related to SSIs will be documented

Other outcomes

  1. Infectious morbidity

    Time frame: Within 30 days from the operation

    Other infectious morbidity, including urinary tract, pulmonary and gastrointestinal infections will be recorded

  2. Postoperative morbidity

    Time frame: Within 30 days from the operation

    Postoperative morbidity non-related to SSI will be documented using the Clavien-Dindo scaling score

  3. Non-SSI related hospital readmissions

    Time frame: Within 30 days from the operation

    Hospital readmission rates that are not attributed to SSIs will be documented

Study contacts

Contact information is provided by the study sponsor or research team.

Vasilios Pergialiotis, Assistant Professor

CONTACT

[email protected]

+302132162291

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients

Acronym: SAFE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

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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