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

• Sponsor: University Hospital Ostrava (Other)
• Overall Status: Completed
• CT.gov ID: NCT03875352
• Collaborator: (none)
• Enrollment: 221
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 6.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Multiorgan Failure; Haematologic Disease	Procedure: CHG technique; Procedure: HMG technique	N/A

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

1. point = Reddening below 2 mm in diameter around the incision

2. points = Reddening below 5 mm in diameter around the incision

3. points = Reddening exceeding 5 mm in diameter around the incision

4. points = Purulent secretion, swelling, pain

5. 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:

1. HMG Group - the patients were treated with 2% chlorhexidine for skin disinfection, HMG and transparent foil

2. 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

3. Neutropenia Group (defined as the number of neutrophil granulocytes below 1x109/l 2. No-neutropenia Group (with a normal number of neutrophil granulocytes

Study Design

• Study Type: Interventional
• Actual Enrollment: 221 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study subjects were randomized into two study arms, in both of which two interventions were performed.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.
• Primary Purpose: Supportive Care
• Official Title: The Influence of Nursing Technique Applied at the Central Venous Catheter Insertion Site Upon the Incidence of Infection
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neutropenia patients Patients with neutropenia were treated using the CHG and HMG technique.	Procedure: CHG technique; The CHG technique includes treatment using dressing with chlorhexidine.; Procedure: HMG technique; The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
Experimental: No neutropenia patients Patients with no neutropenia were treated using the CHG and HMG technique.	Procedure: CHG technique; The CHG technique includes treatment using dressing with chlorhexidine.; Procedure: HMG technique; The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.

Outcome Measures

Primary Outcome Measures

1. Local signs of inflammation [3 days at minimum, up to 15 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ostrava	Ostrava	Moravian-Silesian Region	Czechia	70852

Sponsors and Collaborators

• University Hospital Ostrava

Investigators

• Principal Investigator: Kateřina Hašová, Mgr., University Hospital Ostrava

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Epub 2006 Jun 6. Review. Erratum in: J Antimicrob Chemother. 2010 Apr;65(4):815.
• Lorente L, Henry C, Martín MM, Jiménez 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. Epub 2005 Sep 28.
• 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.

• Responsible Party: University Hospital Ostrava
• ClinicalTrials.gov Identifier: NCT03875352
• Other Study ID Numbers: KHO-01-CVC; RVO-FNOs/2016
• First Posted: Mar 14, 2019
• Last Update Posted: Mar 14, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital Ostrava: central venous catheter; reddening; dressing; hydrophilic methacrylate gel; chlorhexidine gluconate
• Additional relevant MeSH terms: Hematologic Diseases; Multiple Organ Failure

Study Results

No Results Posted as of Mar 14, 2019