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

NCT04540822 | Completed Results

• 1 other identifier: CHD194-19
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

pediatrics; pressure ulcer; peripheral venous catheter

Outcome Measures

Primary Outcomes (1)

• Pressure Ulcer of Grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) Scale

  Occurrence of a pressure ulcer of grade ≥1 according to the NPUAP scale at the catheter extension junction. A higher grade on this scale indicates a worse patient outcome. The assessment will be performed in a blinded manner by a childcare assistant (CDA) from the department.

  at catheter removal

Study Arms (2)

peripheral venous catheter with compress

EXPERIMENTAL

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

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

peripheral venous catheter without compress

ACTIVE COMPARATOR

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

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

Interventions

peripheral venous catheter with compress under the catheter-extension tube junction OTHER

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 with compress

peripheral venous catheter without compress under the catheter-extension tube junction OTHER

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).

peripheral venous catheter without compress

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendee

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Stéphanie BREHU
• Organization: CHD Vendée

stephanie.brehu@ght85.fr

06 88 39 85 17

Study Officials

• stephanie Chaillot

  CHD VENDEE

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The childcare assistant in charge of primary outcome assessment should not having taken care of the child before. In addition, the catheter-extension tube junction, with or without compress,will be secured by placing a crepe bandage. The nurse will call him to assess the primary outcome after the catheter ( and compress and crepe bandage) will have been removed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 7, 2020
• Study Start: September 22, 2020
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)