Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05741866
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2022-12-15
Brief Title:
Novel Antimicrobial Dressing in Peripheral Intravenous Catheters PIVCs
Sponsor:
The University of Queensland
Organization:
The University of Queensland
Study Overview
Official Title:
Protect PIVCs An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters PIVCs
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProP
Brief Summary:
The goal of this clinical trial is to compare a chlorhexidine impregnated dressing for peripheral intravenous catheters PIVCs to the standard dressing currently used in general medical and surgical inpatient wards
The main questions it aims to answer are
Study Feasibility
Occurrence of infectious complications related to the PIVC
Participants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC
The standard dressing used at their hospital or
The intervention dressing which has Chlorhexidine gluconate CHG on it
Researchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC
The main questions it aims to answer are
Study Feasibility
Occurrence of infectious complications related to the PIVC
Participants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC
The standard dressing used at their hospital or
The intervention dressing which has Chlorhexidine gluconate CHG on it
Researchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC
Detailed Description:
This study is a multi-centre two-arm parallel group adaptive Randomized Controlled Trial RCT to test effectiveness cost-effectiveness and safety of 3M Tegaderm Antimicrobial IV Advanced Securement dressings with standard polyurethane dressings for PIVCs The study has two phases Phase I is an internal feasibility pilot for which only feasibility outcomes will be considered no analysis At this time n300 an independent Data Safety Monitoring Committee DSMC comprised of a biostatistician physician and expert trialist will review pre-defined blinded analyses of feasibility and safety data Phase II will then go ahead if feasibility outcomes are satisfactory and will involve continuation of trial recruitment to complete a definitive RCT If Phase II does not proceed then all outcomes will be reported at the end of Phase I
Setting and sample
Australia The ProP Trial will be undertaken in the general medicalsurgical and oncologyhematology departments at the Queensland Childrens Hospital QCH Site 1 and the general medicalsurgical departments at the Royal Brisbane and Womens Hospital RBWH Site 2 Brisbane Australia These are both large quaternary referral teaching hospitals Site 1 359 beds Site 2 929 beds
France The ProP Trial will be undertaken in the University Hospital of Poitiers PUH a large referral teaching hospital with 959 acute beds Patients will be recruited at the Emergency Department before being admitted to medical wards
Sample size
Phase 1 The investigators will recruit 300 patients 200 Australia and 100 France with 150 patients per arm This sample size is not determined by statistical power but to test protocol feasibility and gain estimates of effect to inform a sample size calculation for a full trial The investigators aim to recruit 300 patients over 16 weeks 19 per week
Phase 2 The investigators will continue recruitment to the sample size recommended by the DSMC and the Trial Steering Committee The investigators anticipate this will be no more than a sample of 2624 patients 1312group which would have 90 power to detect an absolute 5 reduction in the primary outcome from 22 to 17 2-way alpha 005 httppowerandsamplesizecomcalculators
Setting and sample
Australia The ProP Trial will be undertaken in the general medicalsurgical and oncologyhematology departments at the Queensland Childrens Hospital QCH Site 1 and the general medicalsurgical departments at the Royal Brisbane and Womens Hospital RBWH Site 2 Brisbane Australia These are both large quaternary referral teaching hospitals Site 1 359 beds Site 2 929 beds
France The ProP Trial will be undertaken in the University Hospital of Poitiers PUH a large referral teaching hospital with 959 acute beds Patients will be recruited at the Emergency Department before being admitted to medical wards
Sample size
Phase 1 The investigators will recruit 300 patients 200 Australia and 100 France with 150 patients per arm This sample size is not determined by statistical power but to test protocol feasibility and gain estimates of effect to inform a sample size calculation for a full trial The investigators aim to recruit 300 patients over 16 weeks 19 per week
Phase 2 The investigators will continue recruitment to the sample size recommended by the DSMC and the Trial Steering Committee The investigators anticipate this will be no more than a sample of 2624 patients 1312group which would have 90 power to detect an absolute 5 reduction in the primary outcome from 22 to 17 2-way alpha 005 httppowerandsamplesizecomcalculators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None