Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nosocomial Infections

Treatments: Drug: 2% Chlorhexidine gluconate cloth

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00549393

NA_00006799

Details and patient eligibility

About

The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

Enrollment: 5,659 patients

Sex: All

Ages: 2 months to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in pediatric intensive care unit

Exclusion criteria

• Patients with a history of an allergic reaction to chlorhexidine
• Patients less than 2 months of age
• Patients with severe skin disease or burn
• Patients with an indwelling epidural catheter or lumbar drain

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5,659 participants in 2 patient groups

1

Experimental group

Description:

Daily bathing with 2% chlorhexidine gluconate

Treatment:

Drug: 2% Chlorhexidine gluconate cloth

2

No Intervention group

Description:

Standard bathing with soap and water basin or disposable cloth