None listed
Conditions
Brief summary
The primary aim of this study is to identify clinical, cost-effective methods to promote haemostasis and prevent PICC dressing failure and associated workloads. The randomised controlled trial also aims to compare current PICC dressing techniques with tissue adhesive (TA) in terms of haemostasis, dressing duration, workload and healthcare costs; and evaluate the acceptability of this product to paediatric and adult patients and health professionals. You may be eligible to participate in this trial if you are receiving treatment in a tertiary health-care setting and a receiving a Peripherally Inserted Central Catheter (PICC) as part of your prescribed care (no age limits). All participants enrolled in this trial will be randomly allocated (by chance) to receive (1) standard care with tissue adhesive (TA) at the PICC insertion site or (2) standard care (with no tissue adhesive). If you are allocated to the Tissue Adhesive (TA) group, the medical-grade glue will be applied at the time of PICC insertion only (one-time application). All participants: standard care dressing and securement will continue to be applied (routinely or as clinically indicated) 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 dressing changes, side effects, device failures and infections. It is hoped that the findings of this trial will provide information of the efficacy and acceptability of medical-grade tissue adhesive to promote haemostatis at the PICC insertion site (to prevent early dressing failure).
Interventions
Participants in this study will have Peripherally Inserted Central Catheters (PICCs) used in adult and paediatric tertiary care settings. The dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserted the PICC).
Arm 1 (Control) (Standard Care: A polyurethane dressing and a sutureless stabilisation device. Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied.
Arm 2 (Intervention - TA): 2-3 dro
Participants in this study will have Peripherally Inserted Central Catheters (PICCs) used in adult and paediatric tertiary care settings. The dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserted the PICC). Arm 1 (Control) (Standard Care: A polyurethane dressing and a sutureless stabilisation device. Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied. Arm 2 (Intervention - TA): 2-3 drops (<1ml) of a tissue adhesive (TA) (SurgiSeal (Registered Trademark); Adhezion) at the PICC insertion site and standard care (a polyurethane dressing and a sutureless stabilisation device). Within the adult setting a chlorhexidine gluconate-impregnated disc will also be applied. The randomly allocated grouping of products will be applied at the time of PICC insertion. TA (if allocated) will not be re-applied (once-only application). To maintain protocol fidelity, each participant will be visited on the day of insertion (during 1st dressing application), ensuring they receive the correct dressing allocation. (TA is not generally available in the tertiary ward setting at the recruiting sites so unintended re-application of TA is not expected.) The patient will also be assessed by the Research Nurse 24 hours later, and then assessed bi-weekly for the first week following PICC insertion to collect data on primary outcomes. Participants will continue to have (minimum) weekly site cleaning and dressing changes (as per policy (7 days) and clinical indication (<7 days)) until the device is removed. All changes (after the initial dressing change) are subsequently uncontrolled.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Require PICC insertion for fluid or medication administration; Likely to remain an inpatient for 24 hours (or more); Able to provide informed consent.
Exclusion criteria
Previous enrolment in the current study this admission; Other vascular access types (e.g., jugular central venous access device); Current catheter-related bloodstream infection; PICC to be inserted through diseased, burned, hirsute, broken or impaired skin (e.g., burn) at the PICC site; Allergy to any study product; and Non-English speaking without an interpreter.
Outcome results
None listed