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Clinical Trials/NCT04540822
NCT04540822CompletedNot Applicable

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

Centre Hospitalier Departemental Vendee1 site in 1 country360 target enrollmentStarted: September 22, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
360
Locations
1
Primary Endpoint
Pressure Ulcer of Grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

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.

Eligibility Criteria

Ages
1 Month to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

peripheral venous catheter with compress

Experimental

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

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

peripheral venous catheter without compress

Active Comparator

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

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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