Effectiveness of Wound Drains for the Prevention Of Surgical sITe infectION (POSITION)

National and Kapodistrian University of Athens

Status: Completed

Conditions: Surgical Site Infection; Gynecologic Cancer; Wound Drain

Treatments: Procedure: Surgical drain

Study type: Interventional

Funder types: Other

Identifiers

NCT05179122

699/8-11-21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Surgical drain

Experimental group

Description:

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

Treatment:

Procedure: Surgical drain

Control

No Intervention group

Description:

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