Effect of intraoperative syringe pressure wound irrigation using saline on the incidence of surgical site infection after gastroenterologic surgery

UMIN ID: UMIN000054324

Registered date:07/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who undergo gastroenterologic surgery
• Date of first enrollment: 2024/05/01
• Target sample size: 1408
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

intraoerative wound irrigation with 100 mL of saline, delivered using a 20ml syringe with a 20 gauge intravenous catherter, applying from at a distance of 10-15cm from the wound tissue for approximately 30 seconds.
intraoperative wound irrigation with 100 mL of saline without any pressure for approximately 30 seconds.

Outcome(s)

• Primary Outcome: The incidence of incisional surgical site infection within 30 days after surgery

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1 Identification of bacterial infection in the surgical field or the use antibiotic therapy prior to the operation. 2 Open wound management for prior operation. 3 Synchronous operation for more than two targeted organs. 4 Presence of a stoma. 5 Pregnancy 6 Under 18 years old 7 Emergency surgery 8 Conditions that make the patient unsuitable for inclusion according to the judgement of non-blinded investigators.

Related Information

• Primary Sponsor: Saitama Medical Center, Jichi Medical University
• Source(s) of Monetary Support: None