Clinical trial · Interventional
Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecological Cancer | — | UNRESOLVED | — |
| Supplemental Oxygen | — | UNRESOLVED | — |
| Surgical Site Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supplemental oxygen therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Supplemental oxygen
- description
- This group 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 case of normal oxygen saturation) for the first 2 postoperative days
- interventionNames
- Behavioral: Supplemental oxygen therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- This group will not receive supplemental oxygen during the first two days of hospitalization
Primary outcomes (2)
- measure
- Surgical site infections
- timeFrame
- Within 30 days from the operation
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available