Clinical Trials Directory

Trials / Completed

CompletedNCT04540822

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
360 (actual)
Sponsor
Centre Hospitalier Departemental Vendee · Academic / Other
Sex
All
Age
1 Month – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERperipheral venous catheter with compress under the catheter-extension tube junctionPlacement 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).
OTHERperipheral venous catheter without compress under the catheter-extension tube junctionPlacement 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).

Timeline

Start date
2020-09-22
Primary completion
2024-06-03
Completion
2024-06-03
First posted
2020-09-07
Last updated
2025-12-23
Results posted
2025-12-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04540822. Inclusion in this directory is not an endorsement.