NCT05705895

Brief Summary

The study aims to evaluate the effectiveness of a central venous catheter (CVC) care protocol, which was created using current guidelines, research results, and expert opinions, on developing CVC-related bloodstream infection in patients with hematopoietic stem cell transplantation (HSCT) until discharge.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 13, 2023

Last Update Submit

January 27, 2023

Conditions

Stem Cell Transplant ComplicationsCentral Venous Catheter Exit Site Infection

Keywords

Central Venous CatheterHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • Patient Descriptive Information Form

    It was developed by the researchers by examining the literature; It contains information about the socio-demographic characteristics of the patients such as age, gender, marital status, educational status, and the planned chemotherapy protocol, previous treatments, and medical conditions such as chronic diseases. There are 8 questions in the first part of the form, which includes socio-demographic characteristics, and 12 questions in the second part, which includes information on medical status..

    Baseline

  • Daily Patient Evaluation Chart

    It was developed by researchers by examining the literature; patients' vital signs (recording of signs of infection such as hypotension, tachycardia, high fever), height-weight measurement results, daily central venous catheter insertion site control results (evaluation findings such as exudate, swelling, redness, discharge, etc.) and routine clinical procedures from patients every day. This is the chart in which the results of whole blood, CRP, Procalcitonin, sedimentation count values and hemoculture routinely taken at every fever, urine culture and catheter tip culture taken during discharge will be recorded. It also includes the control of the protocol implementation steps.

    During the procedure

Study Arms (2)

Intervention Group

EXPERIMENTAL

Catheter care is provided in line with the CVC care protocol developed by the researcher.

Procedure: CENTRAL VENOUS CATHETER CARE PROTOCOL

Control Group

NO INTERVENTION

No intervention will be made to the patients in the control group, and catheter care will be provided in line with the clinical routine.

Interventions

CENTRAL VENOUS CATHETER CARE PROTOCOLPROCEDURE

Catheter care is provided in line with the CVC care protocol developed by the researcher: * For subsequent catheter care, a transparent sterile catheter cover impregnated with 2% chlorhexidine gluconate will be used. * The entry point of the catheter will be wiped with a disposable sterile skin cleaning applicator containing 2% Chlorhexidine Gluconate and 70% Isopropyl Alcohol, which will be provided by the researchers, and wait for it to dry. * Vein valve/needleless connector will be used. * Effective manual disinfection of needle-free connectors (hubs) will be ensured before each intervention. * Needle-free connectors will be replaced every 96 hours at the latest. * If necessary, the catheter lumen will be washed with a disposable, positive-pressure sterile washing system containing 10 ccs 0.9% sodium chloride to be provided by the investigators. * Pulsatile "give stop give stop" technique will be used in the washing process.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being hospitalized by the Medical Oncology Clinic at in a training and research hospital to become an Autologous HSCT,
  • The patient has an 8F-size, two-lumen temporary CVC,
  • Over 18 years of age
  • There is no communication problem,
  • Agreeing to participate in the research voluntarily after being informed about the study,

You may not qualify if:

  • Using a vascular access method other than an 8F size two-lumen temporary CVC in the patient,
  • Refusal to participate in the research voluntarily after being informed about the study,
  • Identification of a different focus of infection in the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Gülhane Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Callister D, Limchaiyawat P, Eells SJ, Miller LG. Risk factors for central line-associated bloodstream infections in the era of prevention bundles. Infect Control Hosp Epidemiol. 2015 Feb;36(2):214-6. doi: 10.1017/ice.2014.32.

    PMID: 25633005BACKGROUND

  • Demiraslan H, Cevahir F, Berk E, Metan G, Cetin M, Alp E. Is surveillance for colonization of carbapenem-resistant gram-negative bacteria important in adult bone marrow transplantation units? Am J Infect Control. 2017 Jul 1;45(7):735-739. doi: 10.1016/j.ajic.2017.01.006. Epub 2017 Feb 15.

    PMID: 28214159BACKGROUND

  • Ferroni A, Gaudin F, Guiffant G, Flaud P, Durussel JJ, Descamps P, Berche P, Nassif X, Merckx J. Pulsative flushing as a strategy to prevent bacterial colonization of vascular access devices. Med Devices (Auckl). 2014 Nov 7;7:379-83. doi: 10.2147/MDER.S71217. eCollection 2014.

    PMID: 25404862BACKGROUND

  • Gunasegaran N, See MTA, Leong ST, Yuan LX, Ang SY. A Randomized Controlled Study to Evaluate the Effectiveness of 2 Treatment Methods in Reducing Incidence of Short Peripheral Catheter-Related Phlebitis. J Infus Nurs. 2018 Mar/Apr;41(2):131-137. doi: 10.1097/NAN.0000000000000271.

    PMID: 29489709BACKGROUND

  • Flint AC, Toossi S, Chan SL, Rao VA, Sheridan W. A Simple Infection Control Protocol Durably Reduces External Ventricular Drain Infections to Near-Zero Levels. World Neurosurg. 2017 Mar;99:518-523. doi: 10.1016/j.wneu.2016.12.042. Epub 2016 Dec 22.

    PMID: 28012890BACKGROUND

Study Officials

  • Canan PORUCU, MsN, RN

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Canan PORUCU, MsN, RN

CONTACT

05344327559cananyaranoglu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients and care providers know which group they are in, but the outcome assessor does not.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, MsN, RN, Principle Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 31, 2023

Study Start

January 1, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)