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

NCT ID: NCT04540822

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2024-06-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

peripheral venous catheter with compress

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 without compress

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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).

Interventions

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

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).

Intervention Type: OTHER

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

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

stephanie Chaillot

Role: STUDY_DIRECTOR

CHD VENDEE

Locations

CHD Vendee

La Roche-sur-Yon, , France

Countries

France

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHD194-19

Identifier Type: -

Identifier Source: org_study_id