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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Surgery, Multiorgan Failure, Haematologic Disease

Intervention / Treatment
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* Procedure: CHG technique
* Procedure: HMG technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects were randomized into two study arms, in both of which two interventions were performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neutropenia patients<br>Patients with neutropenia were treated using the CHG and HMG technique. | Procedure: CHG technique<br>* The CHG technique includes treatment using dressing with chlorhexidine.<br>Procedure: HMG technique<br>* The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.<br>|
| Experimental: No neutropenia patients<br>Patients with no neutropenia were treated using the CHG and HMG technique. | Procedure: CHG technique<br>* The CHG technique includes treatment using dressing with chlorhexidine.<br>Procedure: HMG technique<br>* The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheter, reddening, dressing, hydrophilic methacrylate gel, chlorhexidine gluconate