The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection

NCT03875352 | Completed

• 2 other identifiers: KHO-01-CVCRVO-FNOs/2016
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

Brief Summary

Assessing the impact of the nursing technique applied at the insertion site of the central venous catheter using hydrophilic methacrylate gel (HMG) and 2% Chlorhexidine (CHG) upon the incidence of inflammatory complications when treating the surrounding of the central venous catheter.

Conditions

Surgery; Multiorgan Failure; Haematologic Disease

Keywords

central venous catheter; reddening; dressing; hydrophilic methacrylate gel; chlorhexidine gluconate

Outcome Measures

Primary Outcomes (1)

• Local signs of inflammation

  The local signs of inflammation were observed in both study arms and both interventions, and were assessed according to the scoring system described in detail description.

  3 days at minimum, up to 15 days

Study Arms (2)

Neutropenia patients

EXPERIMENTAL

Patients with neutropenia were treated using the CHG and HMG technique.

Procedure: CHG technique; Procedure: HMG technique

No neutropenia patients

EXPERIMENTAL

Patients with no neutropenia were treated using the CHG and HMG technique.

Procedure: CHG technique; Procedure: HMG technique

Interventions

CHG technique PROCEDURE

The CHG technique includes treatment using dressing with chlorhexidine.

Neutropenia patients; No neutropenia patients

HMG technique PROCEDURE

The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.

Neutropenia patients; No neutropenia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Patients with CVC
• Hospitalization at ICU

You may not qualify if:

• Allergy to HMG
• Allergy to transparent foil
• CVC insertion shorter than 3 days
• Strong bleeding from CVC insertion site

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (5)

• Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.

  PMID: 16002181 BACKGROUND

• Crawford AG, Fuhr JP Jr, Rao B. Cost-benefit analysis of chlorhexidine gluconate dressing in the prevention of catheter-related bloodstream infections. Infect Control Hosp Epidemiol. 2004 Aug;25(8):668-74. doi: 10.1086/502459.

  PMID: 15357159 BACKGROUND

• Ho KM, Litton E. Use of chlorhexidine-impregnated dressing to prevent vascular and epidural catheter colonization and infection: a meta-analysis. J Antimicrob Chemother. 2006 Aug;58(2):281-7. doi: 10.1093/jac/dkl234. Epub 2006 Jun 6.

  PMID: 16757502 BACKGROUND

• Lorente L, Henry C, Martin MM, Jimenez A, Mora ML. Central venous catheter-related infection in a prospective and observational study of 2,595 catheters. Crit Care. 2005;9(6):R631-5. doi: 10.1186/cc3824. Epub 2005 Sep 28.

  PMID: 16280064 BACKGROUND

• Mermel LA. What is the predominant source of intravascular catheter infections? Clin Infect Dis. 2011 Jan 15;52(2):211-2. doi: 10.1093/cid/ciq108.

  PMID: 21288845 BACKGROUND

MeSH Terms

Conditions

Multiple Organ Failure; Hematologic Diseases

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases

Study Officials

• Kateřina Hašová, Mgr.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study was designed as open-label, no masking was used in the protocol.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects were randomized into two study arms, in both of which two interventions were performed.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 14, 2019
• Study Start: February 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)