Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children

Skin Injury Clinical Trial

Official title:

Effectiveness of Care Bundle in Preventing Medical Adhesive-Related Skin Injury Due to Central Venous Catheter Fixation in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122402
• Other study ID #: IUC-SENSOY-MARSI-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Özlem Sensoy, Ms.c.
• Phone: +905070076805
• Email: ozlem.sensoy[@]istanbul.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Skin injury due to the use of medical adhesives is a common but under recognized complication in children. To prevent central venous catheter-related complications, care interventions should be planned in such a way that they do not lead to medical adhesive-related skin injury. Systematic administration of preventive care interventions is needed to reduce skin injuries associated with medical adhesive used for central venous catheter fixation. The SECURE Care Bundle has been developed by researchers based on the latest evidence to prevent medical adhesive-related skin injuries associated with central venous catheter fixation in children.

The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, correctly applying and removing medical adhesives and registering medical adhesive related skin injury.

The goal of this randomized controlled trial study is to evaluate about SECURE care bundle in preventing medical adhesive-related skin injury due to central venous catheter fixation in children.

The main questions it aims to answer are

1. Is the SECURE Care Bundle effective in reducing the incidence of medical adhesive-related skin injuries due to central venous catheter fixation?

2. Does the SECURE Care Bundle have an effect on the first central venous catheter dressing change time?

Data will collect after the parents of the children who meet the case selection criteria will inform about the research, their oral and written consents will be obtained through the "Informed Consent Form".

Researchers will compare the SECURE Care Bundle group to the standard care group to see medical adhesive-related skin injury due to central venous catheter fixation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: September 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 28 Days to 5 Years

Eligibility

Inclusion Criteria:

• The child is being treated with a central venous catheter (CVC) in the intensive care unit

• 28 days to 5 years old

• Patients with a Braden Q score of intermediate risk and above will be included in the study.

Exclusion Criteria:

• Children without CVC,

• Children with previous skin and tissue damage in the area where CVC will be opened,

• Children with allergies to the products used

• Patients who are already receiving treatment with CVC at the beginning of the study periods will not be included in the study.

Related Conditions & MeSH terms

• Skin Injury
• Wounds and Injuries

Intervention

Other:
• SECURE Care Bundle
The SECURE Care Bundle is a systematic approach to care that includes checking the skin, assessing risk factors, registering medical adhesive related skin injury and correctly applying and removing medical adhesives including 2-octyl-cyanoacrylate tissue adhesive, CHG dressing and silicone based remover.

Procedure:
• Standart Care
It is applied in routine care in the clinic. There is no standardization and no procedure for checking the skin, assessing risk factors, registering medical adhesive related skin injury and correctly applying and removing medical adhesives. Only CHG dressing is used for central venous catheter care.

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low incidence of medical adhesive-related skin injury due to central venous catheter fixation	Reducing the incidence of medical adhesive-related skin injury due to central	6 months
Secondary	Longer initial central venous catheter dressing change time	First central venous catheter dressing change time being longer compared to the control group	6 months