Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorNational and Kapodistrian University of Athens
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active immunosuppresion
Preexisting infection of the abdominal wall
Preexisting sepsis
Trial design
Design model
Parallel
Treatments tested in this trial
Supplemental oxygen therapy
BehavioralIn 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
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Supplemental oxygenActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Surgical site infections
Surgical site infections will be evaluated using the Southampton wound scoring system
Time frame
Within 30 days from the operation2
Systemic inflammatory response syndrome
The proportion of patients developing SSI-related systemic inflammatory response will be documented
Time frame
Within 30 days from the operationSecondary outcomes
1
Need for surgical debridement
Need for surgical debridement (bedside or on the operation theatre)
Time frame
Within 30 days from the operation2
Seroma formation
The development of wound seroma will be recorded
Time frame
Within 30 days from the operation3
Wound hematoma
The formation of wound hematoma will be evaluated
Time frame
Within 30 days from the operation4
Uncomplicated wound healing
The proportion of patients with no apparent wound healing problems will be documented
Time frame
Within 30 days from the operationOther outcomes
1
Infectious morbidity
Other infectious morbidity, including urinary tract, pulmonary and gastrointestinal infections will be recorded
Time frame
Within 30 days from the operation2
Postoperative morbidity
Postoperative morbidity non-related to SSI will be documented using the Clavien-Dindo scaling score
Time frame
Within 30 days from the operation3
Non-SSI related hospital readmissions
Hospital readmission rates that are not attributed to SSIs will be documented
Time frame
Within 30 days from the operationSponsors and contacts
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Source ClinicalTrials.gov