Clinical trial NCT06780813: Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
Official title: Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supplemental Oxygen
Gynecological Cancer
Surgical Site Infections
Keywords: Supplemental oxygen
Surgical site infections
Gynecological cancer
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned with computer-generated randomization in two groups: i) the group receiving 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 (phase of hemostasis and inflammation of the surgical wound as well as ii) the control group in which supplemental oxygen will not be administered beyond the basic indications (low saturation, respiratory dysfunction).
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infections
timeFrame: Within 30 days from the operation
measure: Systemic inflammatory response syndrome
timeFrame: Within 30 days from the operation
Secondary outcomes:
measure: Need for surgical debridement
timeFrame: Within 30 days from the operation
measure: Seroma formation
timeFrame: Within 30 days from the operation
measure: Wound hematoma
timeFrame: Within 30 days from the operation
measure: Uncomplicated wound healing
timeFrame: Within 30 days from the operation
measure: Additional wound assisting devices
timeFrame: Within 30 days from the operation
measure: Antibiotic coverage
timeFrame: Within 30 days from the operation
measure: Multidrug resistant pathogens
timeFrame: Within 30 days from the operation
measure: Duration of hospitalization
timeFrame: Within 30 days from the operation
measure: Hospital readmissions related to SSI
timeFrame: Within 30 days from the operation
Other outcomes:
measure: Infectious morbidity
timeFrame: Within 30 days from the operation
measure: Postoperative morbidity
timeFrame: Within 30 days from the operation
measure: Non-SSI related hospital readmissions
timeFrame: Within 30 days from the operation
Locations:
city: Athens
country: Greece
facility: First department of Obstetrics and Gynecology
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Nikolaos Thomakos, Associate Professor
role: STUDY_DIRECTOR
References: