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SurgeryNCT03875352

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

A study testing CHG technique and HMG technique in people with Surgery and Multiorgan Failure, run by University Hospital Ostrava at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgery, Multiorgan Failure, Haematologic Disease
What is being tested?
CHG technique and HMG technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
1 siteCzechia
Study dates
1 Feb 2016to 31 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

Other trials in Czechia

About this study

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.

Read the 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
Being tested
CHG technique, HMG technique
Keywords
central venous catheter, reddening, dressing, hydrophilic methacrylate gel, chlorhexidine gluconate
Medical subject headings
Multiple Organ Failure, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHG techniqueProcedure or surgery

    The CHG technique includes treatment using dressing with chlorhexidine.

  • HMG techniqueProcedure or surgery

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

Study groups in NCT03875352
Study groupRoleWhat they receive
Neutropenia patientsExperimentalPatients with neutropenia were treated using the CHG and HMG technique.
Receives: Procedure: CHG technique; Procedure: HMG technique
No neutropenia patientsExperimentalPatients with no neutropenia were treated using the CHG and HMG technique.
Receives: Procedure: CHG technique; Procedure: HMG technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 days at minimum, up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2019
  2. Study start1 Feb 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study subjects were randomized into two study arms, in both of which two interventions were performed.
Masking
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03875352
Sponsor's protocol ID
KHO-01-CVC
Other IDs
RVO-FNOs/2016
Status last verified
Mar 2019
First submitted
10 Mar 2019
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators have decided not to make individual participant data available to other researchers.

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. doi: 10.1016/j.jhin.2005.01.023.

    PubMed 16002181

  • 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.

    PubMed 15357159

  • 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.

    PubMed 16757502

  • 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.

    PubMed 16280064

  • 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.

    PubMed 21288845

Questions about this trial

What is this clinical trial studying?

A study testing CHG technique and HMG technique in people with Surgery and Multiorgan Failure, run by University Hospital Ostrava at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local signs of inflammation (time frame: 3 days at minimum, up to 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03875352, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.

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