Comparison of Chlorhexidine Impregnated Dressing and Standard Dressing

NCT04794231 | Completed

• 1 other identifier: 2018/0203
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-Related Infections

Keywords

Chlorhexidine dressing; Central venous catheter; Central line associated bloodstream infection; Colonization; Pediatric critical care

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Other: Standard dressing

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.

Other: Chlorhexidine gluconate -impregnated dressing group

Interventions

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)

Standard dressing group

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).

Chlorhexidine gluconate -impregnated dressing group

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

İstanbul Medeniyet Üniversitesi Göztepe Eğitim Ve Araştirma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 12, 2021
• Study Start: May 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: April 2021- August 2021
• Access Criteria: All applications related to scientific goals would be accepted.

Locations

TU (1)