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

Primary Purpose

Surgery, Multiorgan Failure, Haematologic Disease

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
CHG technique
HMG technique
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery focused on measuring central venous catheter, reddening, dressing, hydrophilic methacrylate gel, chlorhexidine gluconate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neutropenia patients

No neutropenia patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2019
Last Updated
March 13, 2019
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT03875352
Brief Title
The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
Official Title
The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study was a prospective and randomized clinical trial. The study was performed at two departments of the University Hospital Ostrava. The design and performance of the study were approved by the Ethics Committee of the University Hospital Ostrava. The patients indicated for insertion of central venous catheter (CVC) were informed about the possible nursing techniques applied at the insertion site of the central venous catheter, participation in the study was conditioned with signing a written informed consent. The study evaluated the superiority of a new procedure in providing nursing care for patients with CVC. Basic patient characteristics were observed and recorded according to the protocol of the study (age, sex, diagnosis), the number of days with CVC inserted, type of dressing, APACHE II score, the presence of neutropenia and the final score of assessment of local signs of inflammation, which was defined as follows: 0 points = No reddening point = Reddening below 2 mm in diameter around the incision points = Reddening below 5 mm in diameter around the incision points = Reddening exceeding 5 mm in diameter around the incision points = Purulent secretion, swelling, pain points = Catheter sepsis The investigators also recorded the day when the first signs of local infection were observed. The obtained results were evaluated with standard statistical techniques (Chí-quadrate test, Fisher's exact test). Upon inserting CVC, the type of draping was recorded (small, middle, large), and the cannulated vein (vena subclavia, left and right, vena jugularis interna, left and right, vena femoralis, left and right). A smear was obtained from around the incision site in all patients after insertion and after extraction; the smears were sent for microbiology cultivation and determination of sensitivity to antibiotic therapy. Changing of the dressings was performed in accordance with standard operating procedures of the University Hospital Ostrava. The CVC was attended under aseptic conditions, using sterile material. Surrounding of CVC was mechanically cleaned and disinfected using 2% chlorhexidine for disinfection of the skin, let to dry, and semipermeable foil was placed at the site, containing chlorhexidine gluconate. The dressing was identified with a date when it was applied. This was left in situ for 3-4 days, and the procedure was repeated. The patients were randomized into two study groups: HMG Group - the patients were treated with 2% chlorhexidine for skin disinfection, HMG and transparent foil CHG Group - the patients were treated with 2% chlorhexidine for skin disinfection and dressing with CHG The randomization procedure further divided the patients into two study arms 1. Neutropenia Group (defined as the number of neutrophil granulocytes below 1x109/l 2. No-neutropenia Group (with a normal number of neutrophil granulocytes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Multiorgan Failure, Haematologic Disease
Keywords
central venous catheter, reddening, dressing, hydrophilic methacrylate gel, chlorhexidine gluconate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study subjects were randomized into two study arms, in both of which two interventions were performed.
Masking
None (Open Label)
Masking Description
The study was designed as open-label, no masking was used in the protocol.
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutropenia patients
Arm Type
Experimental
Arm Description
Patients with neutropenia were treated using the CHG and HMG technique.
Arm Title
No neutropenia patients
Arm Type
Experimental
Arm Description
Patients with no neutropenia were treated using the CHG and HMG technique.
Intervention Type
Procedure
Intervention Name(s)
CHG technique
Intervention Description
The CHG technique includes treatment using dressing with chlorhexidine.
Intervention Type
Procedure
Intervention Name(s)
HMG technique
Intervention Description
The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
Primary Outcome Measure Information:
Title
Local signs of inflammation
Description
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.
Time Frame
3 days at minimum, up to 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years Patients with CVC Hospitalization at ICU Exclusion Criteria: Allergy to HMG Allergy to transparent foil CVC insertion shorter than 3 days Strong bleeding from CVC insertion site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kateřina Hašová, Mgr.
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators have decided not to make individual participant data available to other researchers.
Citations:
PubMed Identifier
16002181
Citation
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.
Results Reference
background
PubMed Identifier
15357159
Citation
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.
Results Reference
background
PubMed Identifier
16757502
Citation
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. Erratum In: J Antimicrob Chemother. 2010 Apr;65(4):815.
Results Reference
background
PubMed Identifier
16280064
Citation
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.
Results Reference
background
PubMed Identifier
21288845
Citation
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.
Results Reference
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The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection

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