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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dressing group | Active Comparator | Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care. |
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| Chlorhexidine gluconate -impregnated dressing group | Active Comparator | Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dressing | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter-related bloodstream infection rate | Catheter infections were identified according to NHSN and IDSA criteria. Catheter-related bloodstream infection defined as bacteremia/fungemia in a patient with an intravascular catheter with at least 1 positive blood culture obtained from a peripheral vein sampled immediately before or within 48 hours after catheter removal, clinical manifestations of infections (ie, fever, chills, and/or hypotension), and no apparent source for the bloodstream infection except the catheter. | Up to 7 days after catheter removal |
| Central-line associated bloodstream infection rate | The presence of either catheter-related bloodstream infections or primary bloodstream infection | Up to 7 days after catheter removal |
| Primary bloodstream infection rate | The presence of patients with central venous catheter who had (i) at least one positive blood culture, (ii) clinical manifestation of infection (i.e., fever, chills, and/or hypotension), (iii) no apparent source for the BSI except the catheter, and (iv) no positivity in catheter culture | Up to 7 days after catheter removal |
| Catheter colonization rate | The growth of >15 CFU in catheter tip cultures in the absence of local or systemic signs of infection or lack of growth in the two blood samples, or in the event that the two cultures showed growth of the same microorganism which was different from the microorganism isolated in the culture of the catheter tip | Up to 7 days after catheter removal |
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Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they:
Additionally, investigators also excluded patients in which
Individuals in which the following events were recorded:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi | Istanbul | Turkey (Türkiye) |
After research will be ended, all data (except personel data which was reflect the patient in his/her own) will be shared to other researchers.
April 2021- August 2021
All applications related to scientific goals would be accepted.
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| ID | Term |
|---|---|
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
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The laboratory microbiologist was blinded to the study groups. The two dressings were visibly different, and consequently, it was not possible to blind the patients, PICU staff or the investigators who collected data in the PICU.
| Chlorhexidine gluconate -impregnated dressing group | Other | 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). |
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