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

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Pressure Ulcer

Treatments: Other: peripheral venous catheter without compress under the catheter-extension tube junction; Other: peripheral venous catheter with compress under the catheter-extension tube junction

Study type: Interventional

Funder types: Other

Identifiers

NCT04540822

CHD194-19

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

peripheral venous catheter with compress

Experimental group

Description:

Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction

Treatment:

Other: peripheral venous catheter with compress under the catheter-extension tube junction

peripheral venous catheter without compress

Active Comparator group

Description:

Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction.

Treatment:

Other: peripheral venous catheter without compress under the catheter-extension tube junction