Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 (n=300) 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 medical/surgical and oncology/hematology departments at the Queensland Children's Hospital (QCH; Site 1), and the general medical/surgical departments at the Royal Brisbane and Women's 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 (1312/group) which would have 90% power to detect an absolute 5% reduction in the primary outcome from 22% to 17% (2-way alpha 0.05) (http://powerandsamplesize.com/calculators). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05741866
Study type Interventional
Source The University of Queensland
Contact ProP - Project Manager
Phone +61 (0) 7 36467671
Email catherine.obrien2@health.qld.gov.au
Status Recruiting
Phase N/A
Start date May 3, 2023
Completion date December 2023

See also
  Status Clinical Trial Phase
Recruiting NCT02905955 - Vacuumtherapy After Venous Hybrid Procedures Phase 4
Not yet recruiting NCT02868372 - Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine N/A
Enrolling by invitation NCT02559453 - Outcomes for 2 Operations Versus ≥ 3 Operations in Infected Wounds N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Active, not recruiting NCT01939145 - Comparing Outcomes for Prontosan Versus Normal Saline for Negative Pressure Wound Therapy With Instillation Phase 4
Completed NCT00998907 - PDS*Plus and Wound Infections After Laparotomy N/A
Completed NCT01141335 - Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair Phase 4
Completed NCT00576745 - A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery Phase 1
Terminated NCT00654641 - Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy N/A
Completed NCT00402727 - Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection Phase 3
Recruiting NCT00150852 - Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus. Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed NCT02018094 - The Amputation Surgical Site Infection Trial (ASSIT) Phase 4
Terminated NCT03269968 - Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery N/A
Enrolling by invitation NCT02945761 - High Concentration of Sugar Solution Irrigation Promotes the Healing of Infected Wound N/A
Not yet recruiting NCT02882360 - Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum Phase 4