Prevention of artificial urinary sphincter infection

JRCT ID: jRCTs031240059

Registered date:01/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Male patients with severe urinary incontinence planned for artificial urinary sphincter implantation
• Date of first enrollment: 15/05/2024
• Target sample size: 42
• Study type: Interventional

Intervention(s)

1)Prior to the start of surgery, spray 100 ml of plasma fine bubble water evenly over the surgical field 5 minutes before disinfecting the surgical field.
2)Clean the surgical field with 5% chlorhexidine gluconate disinfectant solution for 10 minutes using a sponge.
3)After preparing the device for implantation, fill the basin with 400 ml of plasma fine bubble water and immerse the device in the plasma fine bubble water.
4)Before and after device insertion, clean the device insertion space with a total of 500 ml of saline. After gently wiping off moisture with gauze, wash with 550 ml of plasma fine bubble water (total of 500 ml). Close the wound normally.
Regarding prophylactic antibiotic administration during the perioperative period, cefotiam (1 g) or cefazolin (1 g) will be administered intravenously just before the start of surgery and in the evening of the same day, and cefuroxime tablets 250 mg (3 tablets) or amoxicillin-clavulanic acid combination 250 RS with amoxicillin capsules 250 mg (3 tablets with 3 capsules) will be taken orally for 6 days from the morning of the next day after surgery.

Outcome(s)

• Primary Outcome: device-related infection rate

Secondary Outcome

1)device removal rate
2)period from device implantation to occurrence of device-related infection
3)period from device implantation to device removal

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1)Male patients scheduled for new implantation, replacement, or reimplantation of an artificial urinary sphincter for severe urinary incontinence.
2)Patients aged 20 years or older at the time of informed consent
3)Patients who have given their written consent to participate in this clinical study

• Exclude criteria: 1)Patients who are judged to be inappropriate for participation in this study by the research principal (sub-research) physician

Related Information

• Primary Sponsor: Waseda Yuma
• Secondary ID(s): Nil known