National Multicentre Randomised Trial of Superficial Wound Drain on Surgical Site Infection in high Body Mass Index (BMI) Kidney Transplants Recipients

Abstract

Aim: To assess the role of a subcutaneous wound drain on Surgical Site Infection (SSI) rates in kidney transplant recipients with a body mass index (BMI) greater than 30. Patients: Any adult patient undergoing a live or deceased donor kidney transplant with a BMI >30 being implanted in a virgin surgical site. Exclusions: Inclusion in other antimicrobial or immunosuppression trial Routine placement of subcutaneous drain Intervention: Study Group Vacuum drain, minimum 10 French gauge within the subcutaneous layer of the wound and removed at the discretion of the surgical team. Wound closure technique according to surgeon preference and/or local protocols. Control Group Routine wound closure determined by surgeon preference and/or local protocols. No subcutaneous drain inserted. Outcome: Primary Outcome: The incidence of surgical site infection in the first 30 days after transplant. SSI defined as either superficialincisional, deep incisional or organspace using criteria established by the National Healthcare Safety Network (NHSN) of the Centers for Disease Control and Prevention Secondary Outcomes: The SSIrelated readmission rate in the first 30 days after transplant The SSIrelated return to theatre in the first 30 days after transplant Rates of Delayed Graft Function and primary nonfunction Study Design: A multicentre, randomised, openlabel study to investigate the role of a subcutaneous suction wound drain on the rate of surgical site infection in obese (BMI >30) kidney transplant recipients. Study visits will be at baseline and 30 days. Following provision of informed consent, patients will be randomised 1:1 to superficial wound drain or usual care via a computerised online randomisation system. Data collection will be performed by local Investigators and entered online using REDCap (Research Electronic Data Capture) and stored on a secure server.