Trial Outcomes & Findings for Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care (NCT NCT04540822)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

360 participants

Primary outcome timeframe

at catheter removal

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	Peripheral Venous Catheter With Compress Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction 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).	Peripheral Venous Catheter Without Compress Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction. 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).
Overall Study STARTED	180	180
Overall Study COMPLETED	136	137
Overall Study NOT COMPLETED	44	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One observation as a missing data about gender

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peripheral Venous Catheter With Compress n=180 Participants Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction 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).	Peripheral Venous Catheter Without Compress n=180 Participants Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction. 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).	Total n=360 Participants Total of all reporting groups
Age, Continuous	11 years n=180 Participants	9.7 years n=180 Participants	10.5 years n=360 Participants
Sex: Female, Male Female	86 Participants n=180 Participants • One observation as a missing data about gender	85 Participants n=179 Participants • One observation as a missing data about gender	171 Participants n=359 Participants • One observation as a missing data about gender
Sex: Female, Male Male	94 Participants n=180 Participants • One observation as a missing data about gender	94 Participants n=179 Participants • One observation as a missing data about gender	188 Participants n=359 Participants • One observation as a missing data about gender
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	180 participants n=180 Participants	180 participants n=180 Participants	360 participants n=360 Participants

PRIMARY outcome

Timeframe: at catheter removal

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.

Outcome measures

Outcome measures
Measure	peripheral venous catheter without compress n=137 Participants Insertion of a peripheral venous catheter without any compress inserted below the catheter-extension tube junction. 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).	peripheral venous catheter with compress n=136 Participants Insertion of a peripheral venous catheter with a compress inserted below the catheter-extension tube junction 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).
Pressure Ulcer of Grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) Scale	94 Participants	48 Participants

Adverse Events

Peripheral Venous Catheter With Compress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Peripheral Venous Catheter Without Compress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stéphanie BREHU

CHD Vendée

Phone: 06 88 39 85 17

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place