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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
In this arm a surgical drain will be inserted prior to surgical wound closure
Alexandra Hospital
Athens, Attica, Greece
Prevalence of surgical site infection
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Time frame: Within 30 days
Risk of surgical debridement of surgical site infection
Rates of surgical intervention to treat surgical site infection will be recorded
Time frame: Within 30 days
Risk of wound dehiscence
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
Length and depth of wound dehiscence
In case of wound dehiscence the length and depth will be measured in cm
Time frame: Within 30 days
Risk of seroma formation
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
Risk and duration of fever related to surgical site infection
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
Duration of antibiotic therapy directed against surgical site infection
The duration of post-operative use of antibiotics will be recorded in days
Time frame: Within 30 days
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Duration of hospitalization
Duration of hospitalization will be recorded in days
Time frame: Within 30 days
Re-admission rates
Re-admission rates within 30 days will be reported
Time frame: Within 30 days
Interval to adjuvant therapy
The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days
Time frame: Within 30 days