Supplemental OxygenSAFENCT06780813
Supplemental High Flow Oxygen to Reduce Infections in Obese Gynecological Cancer Patients
A study testing Supplemental oxygen therapy in people with Supplemental Oxygen and Gynecological Cancer, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Supplemental Oxygen, Gynecological Cancer, Surgical Site Infections
- What is being tested?
- Supplemental oxygen therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2025to 1 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active immunosuppresion
- Preexisting infection of the abdominal wall
- Preexisting sepsis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
First department of Obstetrics and Gynecology
Athens, 11528
Vasilios Pergialiotis, Assistant Professor, +302132162291, pergialiotis@yahoo.com
About this study
Official title: Supplemental Administration of High Flow Oxygen to Enhance Postoperative Recovery and Reduce Infections in Obese Gynecological Cancer Patients
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.
Read the 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.
- Being tested
- Supplemental oxygen therapy
- Keywords
- Supplemental oxygen, Surgical site infections, Gynecological cancer
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygen therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Supplemental oxygen | Active comparator | 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 Receives: Behavioral: Supplemental oxygen therapy |
| Control group | No intervention | This group will not receive supplemental oxygen during the first two days of hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections
Surgical site infections will be evaluated using the Southampton wound scoring system
Measured: Within 30 days from the operation
Systemic inflammatory response syndrome
The proportion of patients developing SSI-related systemic inflammatory response will be documented
Measured: Within 30 days from the operation
Secondary outcomes (9)
Need for surgical debridement
Need for surgical debridement (bedside or on the operation theatre)
Measured: Within 30 days from the operation
Seroma formation
The development of wound seroma will be recorded
Measured: Within 30 days from the operation
Wound hematoma
The formation of wound hematoma will be evaluated
Measured: Within 30 days from the operation
Uncomplicated wound healing
The proportion of patients with no apparent wound healing problems will be documented
Measured: Within 30 days from the operation
Additional wound assisting devices
The need for vacuum assisted wound healing will be documented
Measured: Within 30 days from the operation
Antibiotic coverage
The need for supplemental antibiotic coverage will be documented
Measured: Within 30 days from the operation
Multidrug resistant pathogens
The proportion of patients with multidrug-resistant pathogens involving SSI will be documented
Measured: Within 30 days from the operation
Duration of hospitalization
The total duration of hospitalization will be documented
Measured: Within 30 days from the operation
Hospital readmissions related to SSI
Readmissions related to SSIs will be documented
Measured: Within 30 days from the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start10 Jan 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supplemental OxygenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Pergialiotis, National and Kapodistrian University of Athens
- Investigators
- Nikolaos Thomakos, Associate Professor, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780813
- Sponsor's protocol ID
- 834/24
- Acronym
- SAFE
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for this study