Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

NCT ID: NCT04794231

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-12-31

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.

Conditions

Catheter-Related Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard dressing group

Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.

Group Type: ACTIVE_COMPARATOR

Standard dressing

Intervention Type: 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)

Chlorhexidine gluconate -impregnated dressing group

Patients were randomly assigned to one of two dressings, both of which were being actively used as part of standard care.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine gluconate -impregnated dressing group

Intervention Type: 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).

Interventions

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)

Intervention Type: 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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medeniyet University

OTHER

Sponsor Role: lead

Responsible Party

Muhterem Duyu

Assistant Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018/0203

Identifier Type: -

Identifier Source: org_study_id