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

Last updated: January 15, 2025
Sponsor: National and Kapodistrian University of Athens
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Supplemental oxygen therapy

Clinical Study ID

NCT06780813
834/24
  • Ages 18-85
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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 thelast cycle and the operation

Exclusion

Exclusion Criteria:

  • Active immunosuppresion

  • Preexisting infection of the abdominal wall

  • Preexisting sepsis

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Supplemental oxygen therapy
Phase:
Study Start date:
January 10, 2025
Estimated Completion Date:
May 01, 2026

Study Description

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.

Connect with a study center

  • First department of Obstetrics and Gynecology

    Athens, 11528
    Greece

    Active - Recruiting

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