CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
peripheral venous catheter with compress under the catheter-extension tube junction +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04540822
NCT04540822N/ACompleted

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

Centre Hospitalier Departemental Vendee·interventional·Posted Sep 7, 2020·Updated Dec 23, 2025

In Brief

A clinical study evaluating peripheral venous catheter with compress under the catheter-extension tube junction and peripheral venous catheter without compress under the catheter-extension tube junction for Pressure Ulcer. Completed, enrolled 360 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Ulcer
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartSep 22, 2020
Primary CompletionJun 3, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 5.8 years ago

Interventions

peripheral venous catheter with compress under the catheter-extension tube junctionother

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 junctionother

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).