None listed
Conditions
Brief summary
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for peripheral intravenous catheters. The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles. Your child may be eligible to participate in this trial if your child is a medical, cardiac or surgical patient under the age of 18 and are having a peripheral venous catheter inserted as part of their therapy (which is expected to remain in place for at least 24 hours). All participants enrolled in this trial will be randomly allocated (by chance) to receive one of three PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants and families will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, device failures and infections. It is hoped that the findings of this trial will provide information on which PVC securements and dressings are most effective in preventing PVC failure.
Interventions
Patients in this study have peripheral venous catheters (PVC) used in paediatric medical, cardiac and surgical departments. Consenting participants (consent achieved from legal guardian) will have their PVC secured with either the interventions or control dressing and securements. This dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserts the PVC).
Arm 1 (Control): Bordered Polyurethane Dressing. Bordered polyurethane dressin
Patients in this study have peripheral venous catheters (PVC) used in paediatric medical, cardiac and surgical departments. Consenting participants (consent achieved from legal guardian) will have their PVC secured with either the interventions or control dressing and securements. This dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserts the PVC). Arm 1 (Control): Bordered Polyurethane Dressing. Bordered polyurethane dressings (BPUs) retain the central polyurethane component of standard polyurethane dressings with an added external adhesive border of foam or cloth fabric. Arm 2 (Intervention): Integrated Securement Device. An Integrated Securement Device is a polyurethane dressing which combines both SP (simple polyurethane) and SD (securement device) into one product. Arm 3: (Intervention): Tissue Adhesive (TA). TA is a medical grade 'superglue' (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing will also be applied. The randomly allocated dressing will be applied at the time of PVC insertion until device removal. There will be daily checks of the PVC site and dressings/securements to monitor protocol adherence and assess for any complications.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Informed written consent 2. PVC in situ 3. PVC scheduled/expected use >24 hours 4. Patient aged 18 years or less. 5, Patient admitted to a Medical, Cardiac or Surgical ward
Exclusion criteria
1. Known, current bloodstream infection (within 48 hours) 2. Non-English speakers without interpreter 3. PVCs inserted through diseased, burned or scarred skin 4. Other types of vascular access devices 5. Current skin tear/‘papery’ skin at high risk of tear 6. Known allergy to any study product 7. Previous enrolment in the current study
Outcome results
None listed