NCT04794231

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing for the Prevention of Central-line Associated Blood Stream Infection and Colonization in Critically Ill Pediatric Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

Investigators have designed a single-center randomized controlled trial to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the infection outcomes. The study was condcuted in the pediatric intensive care unit in the 18 months period.

Detailed description

The single-center randomized controlled trial study aimed to compare chlorhexidine gluconate (CHG)-impregnated dressing and standard dressing with respect to their effects on the frequency of central-line associated bloodstream infection (CLABSI), catheter related bloodstream infection (CRBSI), primary bloodstream infection (BSI) and catheter colonization in critically ill pediatric patients with short-term non-tunneled central venous catheter (CVC) in a pediatric intensive care unit (PICU) of a tertiary referral hospital in Turkey.. Pediatric patients aged 1 month to 18 years admitted to our PICU between May 2018 and December 2019, who had received placement of a short-term non-tunneled CVC which had stayed in place for at least 48 hours were included into the study. The patients were grouped with respect to the type of catheter fixation they had received, either with CHG-impregnated dressing or standard dressing, which were assigned in a randomized fashion. The groups were compared with regard to the frequencies of CLABSI, CRBSI, primary BSI and catheter colonization, as well as microorganism etiology. Any adverse event related to catheter dressing were recorded. Independent risk factors of CLABSI frequency were analyzed.

Conditions

• Catheter-Related Infections

Interventions

Type	Name	Description
OTHER	Standard dressing	a standard breathable, hypoallergenic, transparent dressing (TegadermTM 1635 \[8.5 x 10.5cm\] or 1633 \[7 × 8.5 cm\] depending on patient size; 3M, Neuss, Germany)
OTHER	Chlorhexidine gluconate -impregnated dressing group	A chlorhexidine gluconate -gel impregnated transparent dressing (TegadermTM CHG 1660R \[7 x 8.5 cm\] or \[11.5 x 8.5 cm\] depending on patient size; 3M, Neuss, Germany).

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2021-03-12
• Last updated: 2021-03-15

Locations

1 site across 1 country: Turkey (Türkiye)