Infections

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Wounds and Injuries

Communicable Diseases

Surgical Wound Infection

Obesity

Surgical Wound

Wound Infection

Postoperative Complications

In this arm participants a surgical drain (Redon type) will be inserted above the abdominal fascia prior to suture of the subcutaneous tissue and of the skin

In this arm the subcutaneous tissue and the skin of the surgical wound will be sutured without insertion of any type of drain

In this arm a surgical drain will be inserted prior to surgical wound closure

Surgical drain

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.

The statistician involved in the statistical analyses of results will be blinded to the arm of treatment

Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION

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

Surgical site infection will be defined as redness, swelling, pain, bleeding, or any discharge from the surgical site

Rates of surgical intervention to treat surgical site infection will be recorded

Rates of wound dehiscence (skin and/or fascia dehiscence) following surgical site infection or spontaneously (non-related to surgical site infection) will be recorded

In case of wound dehiscence the length and depth will be measured in cm

Rates of formation of seroma (defined as the collection of non-purulent fluid) in the surgical wound will be recorded.

Rates of fever related to surgical site infection and following exclusion of other causes will be reported in degrees of Celsius

The duration of post-operative use of antibiotics will be recorded in days

Duration of hospitalization will be recorded in days

Re-admission rates within 30 days will be reported

The interval to adjuvant therapy (chemo- and/or radiotherapy) will be recorded in days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION	NCT05179122	Surgical Site I... Gynecologic Can... Wound Drain	Surgical drain	30 Years - 85 Years	National and Kapodistrian University of Athens
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION	NCT05179122	Surgical Site I... Gynecologic Can... Wound Drain	Surgical drain	30 Years - 85 Years	National and Kapodistrian University of Athens
Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION	NCT05179122	Surgical Site I... Gynecologic Can... Wound Drain	Surgical drain	30 Years - 85 Years	National and Kapodistrian University of Athens

Spots Global Cancer Trial Database for surgical drain