Clinical trial NCT04540822: Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
Official title: Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: pediatrics
pressure ulcer
peripheral venous catheter
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 360
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pressure ulcer of grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) scale
timeFrame: at catheter removal
Secondary outcomes:
measure: Pressure ulcer intensity as measured by the NPUAP scale
timeFrame: at catheter removal
measure: dwell time of peripheral venous catheters between the 2 groups
timeFrame: at catheter removal
measure: Presence of a nosocomial infection related to the peripheral venous catheter.
timeFrame: at catheter removal +48hours
Other outcomes:
Locations:
city: La roche sur yon
country: France
facility: CHD Vendee
Study officials:
affiliation: CHD VENDEE
name: stephanie Chaillot
role: STUDY_DIRECTOR
References: