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Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to evaluate an integrated securement device for peripheral intravenous catheters in medical and surgical patients.

Randomised controlled trial of an integrated securement device (ISD) versus standard care (bordered polyurethane) dressings on intravascular catheter failure in medical and surgical patients.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000984493
Acronym
The SMILE Trial
Enrollment
300
Registered
2016-07-27
Start date
2016-10-12
Completion date
2017-07-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. You may be eligible to participate in this trial if you are a medical or surgical patient over the age of 16 and are having a peripheral venous catheter inserted as part of your 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 two PVC dressing/securement options. This will be either the standard bordered polyurethane dressing; or an integrated securement device. The allocated dressing will be applied from device insertion until the time of device removal. Participants 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 adult medical and surgical departments. Consenting patients will have their PVC secured with either the intervention 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 sta

Patients in this study have peripheral venous catheters (PVC) used in adult medical and surgical departments. Consenting patients will have their PVC secured with either the intervention 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. 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
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Informed written consent 2. PVC in situ 3. PVC scheduled/expected use >24 hours 4. Patient aged 16 years or above. 5, Patient admitted to a Medical 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

Source: ANZCTR · Data processed: Mar 5, 2026