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N/A N=360 Randomized Single-blind Prevention

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

Pressure Ulcer

Enrolled (actual)
360
Serious AEs
Results posted
Dec 2025
Primary outcome: Primary: Pressure Ulcer of Grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) Scale — 48; 94 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
peripheral venous catheter with compress under the catheter-extension tube junction (Other); peripheral venous catheter without compress under the catheter-extension tube junction (Other)
Age
Pediatric, Adult · 0+ yrs
Sex
All
Sponsor
Centre Hospitalier Departemental Vendee
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Pressure Ulcer of Grade >=1 on the National Pressure Ulcer Advisory Panel (NPUAP) Scale
48; 94

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04540822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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