Extra oxygen during surgery to prevent wound infections in obese women with gynecological cancer

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with a gynecological cancer who are obese and are having surgery. It studies whether extra oxygen lowers wound infections.

Age

18 to 85 years

Sex

Women only

Disease stage

Gynecological cancer with surgery planned. BMI above 30kg/m2.

Earlier treatment

If you had neoadjuvant therapy (treatment before surgery), more than three weeks must pass between the last cycle and the operation.

Biomarker or test result

Before surgery, blood tests must be in range: hemoglobin >11g/dl, WBC 4.000-11.000 X 109/L, platelets 150,000 to 400,000 X 109/L.

Main reasons for not taking part

• Active immunosuppresion
• Preexisting infection of the abdominal wall
• Preexisting sepsis

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 85 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Supplemental oxygenExisting treatment, for comparison

  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

  Treatment: Supplemental oxygen therapy

• Control groupNo study treatment, for comparison

  This group will not receive supplemental oxygen during the first two days of hospitalization