Gynecologic Cancer, Surgical Site Infection, Wound Drain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESurgical drain
In this arm a surgical drain will be inserted prior to surgical wound closure
Sponsors
Aristotle University Of Thessaloniki
Saint Savvas Anticancer Hospital
Metaxa Hospital
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistician involved in the statistical analyses of results will be blinded to the arm of treatment
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of surgical debridement of surgical site infection | Within 30 days | Rates of surgical intervention to treat surgical site infection will be recorded |
| Prevalence of surgical site infection | Within 30 days | Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length and depth of wound dehiscence | Within 30 days | In case of wound dehiscence the length and depth will be measured in cm |
| Risk of seroma formation | Within 30 days | Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded. |
| Risk and duration of fever related to surgical site infection | Within 30 days | Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius |
| Duration of hospitalization | Within 30 days | Duration of hospitalization will be recorded in days |
| Re-admission rates | Within 30 days | Re-admission rates within 30 days will be reported |
| Interval to adjuvant therapy | Within 30 days | The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days |
| Duration of antibiotic therapy directed against surgical site infection | Within 30 days | The duration of post-operative use of antibiotics will be recorded in days |
| Risk of wound dehiscence | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year | 3-year survival rate |
Countries
Greece
Outcome results
None listed