Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supplemental oxygen therapy.
- Who it may be relevant to
- Registry conditions: Supplemental Oxygen, Gynecological Cancer, Surgical Site Infections. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
Overview
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.
Interventions
- Behavioral Supplemental oxygen therapy
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 outcome measures
- Surgical site infections [Time frame: Within 30 days from the operation]
- Systemic inflammatory response syndrome [Time frame: Within 30 days from the operation]
Secondary outcome measures (9)
- Need for surgical debridement [Time frame: Within 30 days from the operation]
- Seroma formation [Time frame: Within 30 days from the operation]
- Wound hematoma [Time frame: Within 30 days from the operation]
- Uncomplicated wound healing [Time frame: Within 30 days from the operation]
- Additional wound assisting devices [Time frame: Within 30 days from the operation]
- Antibiotic coverage [Time frame: Within 30 days from the operation]
- Multidrug resistant pathogens [Time frame: Within 30 days from the operation]
- Duration of hospitalization [Time frame: Within 30 days from the operation]
- Hospital readmissions related to SSI [Time frame: Within 30 days from the operation]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Greece · 1 center
- First department of Obstetrics and Gynecology — Athens
Identifiers
NCT: NCT06780813 · 834/24