Status:
COMPLETED
Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing
Lead Sponsor:
Istanbul Medeniyet University
Conditions:
Catheter-Related Infections
Eligibility:
All Genders
1-17 years
Phase:
NA
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 infecti...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT04794231
Start Date
May 1 2018
End Date
December 31 2019
Last Update
March 15 2021
Active Locations (1)
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1
İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi
Istanbul, Turkey (Türkiye)