Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care

Pressure Ulcer Clinical Trial

— KTESCA  

Official title:

Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540822
• Other study ID #: CHD194-19
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: September 29, 2024

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Departemental Vendee
• Contact: Laura SOULARD
• Phone: 0251080582
• Email: laura.soulard[@]ght85.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral venous catheterisation is a multi-daily practice in a paediatric ward. In our pediatrics department, nurses have observed for several years now the appearance of pressure sore-like skin lesions at the junction of the peripheral venous catheter with the extension tube. A ward habit has spontaneously developed of applying a compress under this junction. The objective is to minimize physical or emotional aggression as well as pain. Pain that is denied or not identified and not relieved is memorized by the child, which can have consequences on the perception of pain and the subsequent acceptance of care. To date, through their reading and research, investigators have been able to find articles mentioning the risks of pressure ulcers in children related to medical devices. However, few elements are developed concerning catheter-related pressure ulcers, especially on this specific technique for preventing injuries at the catheter-extension tube junction. Investigators have not found any recommendations on this subject. Thus, the aim of this study is to compare two peripheral venous catheter fixation devices, with compress and without compress, and to analyse the frequency of pressure ulcer occurrence and the intensity of this lesion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• Aged 1 month to 18 years old, according to the criteria of the paediatrics department of the Departmental Hospital la Roche sur Yon .
• Hospitalized in paediatrics ward or consultant in paediatric emergencies with a high probability of being hospitalized in paediatrics ward later.
• With an indication for the insertion of a short peripheral venous catheter
• Written agreement from the holder(s) of parental authority

Exclusion Criteria:

• Children with dermatological affections prior to inclusion and at the puncture site (atopic dermatitis, skin infection, skin wound, chickenpox, epidermolysis bullosa)
• Allergy to fixation devices
• Known immune deficient child
• Refusal of the patient or of the holders of parental authority to participate
• Life-saving emergency care
• Patient already included in the study
• Patient without social security coverage

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Other:
• peripheral venous catheter with compress under the catheter-extension tube junction
Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. Under the catheter-extension tube junction will be inserted a sterile non-woven compress, cut sterilely (3.5x1.5 cm). The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
• peripheral venous catheter without compress under the catheter-extension tube junction
Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. No compresses will be inserted under the catheter-extension tube junction.The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).

Locations

Country	Name	City	State
France	CHD Vendee	La roche sur yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer of grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) scale	Appearance of a grade >=1 pressure ulcer on the NPUAP scale at the catheter extension junction. The assessment will be conducted blind by a child care assistant (CDA) from the department.	at catheter removal
Secondary	Pressure ulcer intensity as measured by the NPUAP scale	The NPUAP pressure ulcer rating scale translated in French by the National French Agency for accreditation and assessment of Health (ANAES) will be used. This scale evaluates pressure ulcers according to 4 stages graduated from 1 to 4. Stage 1 being the least severe.	at catheter removal
Secondary	dwell time of peripheral venous catheters between the 2 groups	Will be calculated from the time of catheter placement to the time of catheter removal.	at catheter removal
Secondary	Presence of a nosocomial infection related to the peripheral venous catheter.	Will be defined as a peripheral venous catheter culture > 10^3 Colony Forming Unit/ml, if the peripheral venous catheter is referred in culture on suspicion of infection and in the absence of antibiotic treatment. In the presence of antibiotic treatment, it will be defined by the presence of pus and/or regression of infectious signs within 48 hours after removal of the peripheral venous catheter.	at catheter removal +48hours