NCT05179122

Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

A Randomized Trial of Abdominal Wound Drainage in Obese Gynecologic Oncology Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: Female
• Age: 30 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Site Infection
• Gynecologic Cancer
• Wound Drain

Interventions

Type	Name	Description
PROCEDURE	Surgical drain	In this arm a surgical drain will be inserted prior to surgical wound closure

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2024-01-15
• First posted: 2022-01-05
• Last updated: 2024-02-02

Locations

1 site across 1 country: Greece