Alexandra Hospital
Athens, Attica, 11528, Greece
NCT Number: NCT05179122
The aim of the present randomized trial is to assess the efficacy of wound drains in terms of reducing the rates of surgical site infection in obese patients with gynecological cancer.
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Notify Me30 year–85 year
Female
Interventional
Not applicable
Athens, Attica, 11528, Greece
Many prophylactic methods have been suggested for the treatment of surgical wound infections, including the prolonged administration of antibiotics as well as the use of subcutaneous tissue drainage, the use of which has been shown to be particularly effective in overweight patients. While its importance seems to be moderate in obese patients as well as those that suffer from malignant disease, to date, it remains unknown if wound drains may help reduce the rates of surgical site infection in obese patients that suffer from cancer. In the field of gynecological oncology data are limited to anachronistic studies whose methodological value is limited; hence, guidelines are primarily based in data of high risk of bias as to date, the value of subcutaneous tissue drainage in obese women undergoing surgery for gynecological cancer has not been documented in a large randomized study.
Considering the significant impact of surgical site infection on the interval to adjuvant therapy (as patients with infectious diseases cannot receive chemotherapy or radiotherapy), it becomes evident that every effort has to be made in order to help reduce the rates of SSI to help maintain acceptable intervals that will ensure appropriate care of patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
This prospective randomized study will include obese (BMI> 35) patients who will undergo primary surgery for ovarian or endometrial cancer
Exclusion criteria
Immunodeficient patients (systemic disease including HIV infection, systemic lupus erythematosus etc) Patients with hematologic diseases
In this arm a surgical drain will be inserted prior to surgical wound closure
Time frame: Within 30 days
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Time frame: Within 30 days
Rates of surgical intervention to treat surgical site infection will be recorded
Time frame: Within 30 days
Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded
Time frame: Within 30 days
In case of wound dehiscence the length and depth will be measured in cm
Time frame: Within 30 days
Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded.
Time frame: Within 30 days
Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius
Time frame: Within 30 days
The duration of post-operative use of antibiotics will be recorded in days
Time frame: Within 30 days
Duration of hospitalization will be recorded in days
Time frame: Within 30 days
Re-admission rates within 30 days will be reported
Time frame: Within 30 days
The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days
Time frame: 3-year
3-year survival rate
Time frame: 5-year
5-year survival rate
National and Kapodistrian University of Athens
Other
A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
Acronym: POSITION
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