Clinical trial NCT04794231: Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter-Related Infections
Keywords: Chlorhexidine dressing
Central venous catheter
Central line associated bloodstream infection
Colonization
Pediatric critical care
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 307
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* being aged age less than 18 years old,
* providing informed consent to participate in the study
* insertion of a short term non-tunneled, percutaneously inserted CVC (jugular, subclavian, or femoral) that would remain in place for greater than 48 hours during PICU admission.

Exclusion Criteria:

Patients were excluded if they:

* had known allergies to CHG-impregnated or standard dressing,
* would receive insertion of any other type of CVC device (e.g., peripherally inserted CVC, tunneled CVC), were included in the study previously,
* had a current BSI (positive blood culture within 48 hours),
* had received CVC insertion within the 30 days prior to PICU admission.

Additionally, investigators also excluded patients in which

* catheterization had not been performed by the PICU specialist,
* those that were discharged from the PICU with indwelling CVC,
* patients who received extracorporeal membrane oxygenation,

Individuals in which the following events were recorded:

* Accidental catheter removal,
* CVC removal before 48 hours, and
* death within 48 hours after CVC insertion.

In the event that a patient required CVC re-insertion after the initial catheter was removed (due to any reason), only the first application was included in the study -given that any other exclusion criteria did not exclude the patient. Finally, if a patient required catheter reinsertion before the completion of the 48-hour catheter-infection monitoring of the initial application, the first catheterization was excluded from the study.

Primary outcomes:
measure: Catheter-related bloodstream infection rate
timeFrame: Up to 7 days after catheter removal
measure: Central-line associated bloodstream infection rate
timeFrame: Up to 7 days after catheter removal
measure: Primary bloodstream infection rate
timeFrame: Up to 7 days after catheter removal
measure: Catheter colonization rate
timeFrame: Up to 7 days after catheter removal
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi
Study officials:
References: