A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgical Site Infection
- Sponsor
- National and Kapodistrian University of Athens
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Prevalence of surgical site infection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Dimitrios Haidopoulos
Associate Professor of Obstetrics and Gynecology
Alexandra Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Prevalence of surgical site infection
Time Frame: Within 30 days
Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site
Risk of surgical debridement of surgical site infection
Time Frame: Within 30 days
Rates of surgical intervention to treat surgical site infection will be recorded
Secondary Outcomes
- Risk of wound dehiscence(Within 30 days)
- Length and depth of wound dehiscence(Within 30 days)
- Risk of seroma formation(Within 30 days)
- Duration of antibiotic therapy directed against surgical site infection(Within 30 days)
- Re-admission rates(Within 30 days)
- Interval to adjuvant therapy(Within 30 days)
- Risk and duration of fever related to surgical site infection(Within 30 days)
- Duration of hospitalization(Within 30 days)