Vascular Access ComplicationProPNCT05741866
Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)
A study testing Chlorhexidine gluconate impregnated bordered polyurethane dressing and Standard bordered polyurethane dressing in people with Vascular Access Complication and Device Related Infection, run by The University of Queensland at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication, Device Related Infection, Device Related Sepsis
- What is being tested?
- Chlorhexidine gluconate impregnated bordered polyurethane dressing and Standard bordered polyurethane dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 3 May 2023to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PIVC to be inserted with expected dwell >48 hours
- Provided written and informed consent (patient or carer)
- Australia only
- ≥6 years of age (due to size of dressing)
- France only
- ≥18 years of age
Who cannot join
- Burned, non-intact or scarred skin at the insertion site
- Known allergy to CHG or transparent dressing adhesives
- Palliative care patients on end-of-life pathway
- Patient who has already participated in the study
- Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.
- Additional exclusions to Australian study only
Show all 13Show fewer
- Non-English-speaking patients without interpreter
- Under the care of Child and Family Services and unable to gain consent from case worker (paediatric patients)
- Additional exclusions to French study only
- Patients not benefiting from the French Social Security scheme or not benefiting from it through a third party,
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
- Known pregnant or breastfeeding women
- Predictably difficult vascular access (IV drug addiction, obesity)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Queensland Children's Hospital
South Brisbane, Queensland, 4101
About this study
Official title: Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
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:
Read more
- 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.
Read the 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 (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).
- Conditions
- Vascular Access Complication, Device Related Infection, Device Related Sepsis, Device Site Reactions, Catheter Infection, Catheter Complications
- Being tested
- Chlorhexidine gluconate impregnated bordered polyurethane dressing, Standard bordered polyurethane dressing
- Keywords
- Peripheral Intravenous Catheter, PIVC, Intravenous, Vascular access device, randomised controlled trial, phlebitis, chlorhexidine gluconate, CHG dressing
- Medical subject headings
- Prosthesis-Related Infections, Catheter-Related Infections, Wound Infection, Wounds and Injuries, Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate impregnated bordered polyurethane dressingDevice
Also called Tegaderm™ Antimicrobial I.V. Advanced Securement (9132)
PIVCs will be dressed and secured at the participating sites
- RBWH and PUH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with non-sterile tape over extension tubing.
- QCH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.
Standard bordered polyurethane dressingDevice
Also called Tegaderm™ IV Advanced (1682 or 1683)
PIVCs will be dressed and secured as per standard practice at the participating sites
- RBWH and PUH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1683) and non-sterile tape strip over extension tubing.
- QCH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1682 or 1683) and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Bordered Polyurethane Dressing Receives: Device: Standard bordered polyurethane dressing |
| Intervention | Experimental | CHG Bordered Polyurethane Dressing Receives: Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for a definitive RCT
The feasibility of conducting a definitive RCT will be assessed against the following criteria:
- Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion) ii. Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study) iii. Retention of study participants (<10% will be lost to follow up) iv. Protocol fidelity of study participants (≥80% will receive the allocated intervention) v. Missing data for primary outcome 2 (<5% of primary outcome 2 data will be unable to be collected) vi. Satisfaction of participants/parents and staff (<10% report "low" satisfaction with the intervention arm (rated low/medium/high) vii. An estimate of catheter-related infectious complications (defined as per primary outcome 2) in the control group that indicate a fully powered multi-site RCT is achievable
Measured: On completion of 300 participants
Catheter-related infectious complications and phlebitis
Proportion of patients with a composite measure of PIVC Colonization; PIVC local infection; PIVC-associated Bloodstream Infection (BSI) and Phlebitis. These measures are defined below in secondary outcomes.
If patients meet more than one of the following [e.g., phlebitis and PIVC local infection], both will be collected however only counted once for the composite measure.
Measured: Daily until 48hours after study PIVC is removed.
Secondary outcomes (12)
PIVC tip colonization
>15 cfu of a pathogen semi-quantitative method, or ≥1000 cfu of a pathogen per mL broth method.
PIVC tips will be collected based on Nurse and laboratory availability at time of PIVC removal.
Measured: Daily until 48hours after study PIVC is removed.
PIVC local infection without Bloodstream Infection (BSI)
Proportion of patients with a PIVC local infection without BSI as defined by NHSN 2021 criteria for Cardiovascular System VASC-Arterial or Venous Infection (CVS-VASC); adult and child/infant criteria.
Collected daily by either the research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
Measured: Daily until 48hours after study PIVC is removed.
PIVC-associated Bloodstream Infection
Proportion of patients with a laboratory Confirmed Bloodstream Infection, as defined by NHSN 2021 adult and infant criteria
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
Measured: Daily until 48hours after study PIVC is removed.
Phlebitis
Either pain or tenderness [>1 on a scale of 0 to 10]), or at least 2 of erythema, swelling, purulence or palpable cord.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
Measured: Daily until 48hours after study PIVC is removed.
PIVC device failure
Proportion of patients, a composite of infiltration/ extravasation, blockage/occlusion (with/without leakage), phlebitis (as defined above), thrombosis, dislodgement (complete/partial) or infection (as defined above).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
Measured: Daily until 48hours after study PIVC is removed.
Dressing durability
Proportion of patients with dressing durability assessed as:
(i) the dressing remains adhered to the skin on all four sides until PIVC removal; and, (ii) accidental dislodgement (excluding patients who deliberately remove their PIVC).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
Measured: Daily until study PIVC is removed.
Skin colonization
Reported semi-quantitatively as scant, 1+, 2+, 3.
PIVC skin swabs will be collected based on Nurse and laboratory availability at time of PIVC removal.
Measured: On study PIVC removal
Adverse skin event
Proportion of patients with skin complications at PIVC site: mechanical (e.g. pressure injury, skin tears, blisters, bruising) or inflammatory complications (e.g. contact/allergic dermatitis, skin rash, pruritus).
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
Measured: Daily until 48hours after study PIVC is removed.
Serious adverse event
Proportion of patients with anaphylactic reaction to CHG in dressing; or mortality related to PIVC infection.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.
Measured: Daily until 48hours after study PIVC is removed.
Cost effectiveness
Direct and indirect healthcare costs to the health system, including cost per complication avoided.
Collected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record and microbiology results.
A random subset of 15% of participants will have all subsequent devices recorded until completion of treatment for the participant's current admission. Date of discharge will be recorded for all participants to calculate length of stay.
Measured: Until discharge.
Patient reported experience measures of the dressing
Proportion of participants/parents who report their satisfaction with the dressing rated low/medium/high with respective prompts of:
- "I'd rather use a different dressing next time"
- "The dressing was ok, but I'm happy to try other types"
- "It was a really good dressing and I'd like to use this one again"
A Patient-Reported Experience Measure survey will be conducted on study PIVC removal.
Patient's will have the opportunity to comment on the dressing and their satisfaction with it at any time during study participation.
Measured: Daily until 48hours after study PIVC is removed.
Clinician reported experience measures of the dressing including application and removal
Proportion of clinicians who report their satisfaction with the dressing rated low/medium/high with respective prompts of:
- "I'd rather use a different dressing next time"
- "The dressing was ok, but I'm happy to try other types"
- "It was a really good dressing and I'd like to use this one again"
Collected opportunistically between dressing application to 48 hours after study PIVC removal.
Measured: Daily until 48hours after study PIVC is removed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start3 May 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, two-arm, parallel group adaptive randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Queensland Children's Hospital, Royal Brisbane and Women's Hospital, Poitiers University Hospital, Griffith University
- Responsible party
- Sponsor
- Investigators
- Claire Rickard, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741866
- Sponsor's protocol ID
- 2022/HE001952
- Acronym
- ProP
- Status last verified
- Nov 2022
- First submitted
- 15 Dec 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Available to individuals who provide a methodologically sound proposal and at the discretion of the Principal Investigator.
Publications
Drugeon B, Ball DL, Kleidon TM, O'Brien C, Mihala G, Marsh N, Ullman A, Corley A, Schults JA, Guenezan J, McCarthy K, Seguin S, Batiot G, Byrnes J, Silva TL, Mimoz O, Rickard CM. An international randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial). Antimicrob Resist Infect Control. 2026 May 25;15(1):94. doi: 10.1186/s13756-026-01767-y.
PubMed 42186074Rickard CM, Drugeon B, Ullman A, Marsh NM, Corley A, Ball D, O'Brien C, Kleidon TM, Guenezan J, Couvreur R, McCarthy KL, Seguin S, Batiot G, Byrnes J, Schults J, Zahir SF, Mimoz O. Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial). BMJ Open. 2024 Jul 16;14(7):e084313. doi: 10.1136/bmjopen-2024-084313.
PubMed 39013653
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).
- ClinicalTrials.gov ID
- NCT05741866
- Acronym / sponsor ID
- ProP / 2022/HE001952
- Conditions
- Vascular Access Complication, Device Related Infection, Device Related Sepsis, Device Site Reactions, Catheter Infection, Catheter Complications
- Keywords
- Peripheral Intravenous Catheter, PIVC, Intravenous, Vascular access device, randomised controlled trial, phlebitis, chlorhexidine gluconate, CHG dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Queensland Children's Hospital, Royal Brisbane and Women's Hospital, Poitiers University Hospital, Griffith University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-centre, two-arm, parallel group adaptive randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Standard bordered polyurethane dressingBordered Polyurethane Dressing |
| Intervention | Experimental | Device: Chlorhexidine gluconate impregnated bordered polyurethane dressingCHG Bordered Polyurethane Dressing |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- PIVC to be inserted with expected dwell >48 hours
- Provided written and informed consent (patient or carer)
- Australia only
- ≥6 years of age (due to size of dressing)
- France only
Key exclusion criteria (13 listed)
- Burned, non-intact or scarred skin at the insertion site
- Known allergy to CHG or transparent dressing adhesives
- Palliative care patients on end-of-life pathway
- Patient who has already participated in the study
- Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chlorhexidine gluconate impregnated bordered polyurethane dressingAlso: Tegaderm™ Antimicrobial I.V. Advanced Securement (9132)PIVCs will be dressed and secured at the participating sites * RBWH and PUH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with non-sterile tape over extension tubing. * QCH: PIVCs will be dressed with Tegaderm™ Antimicrobial I.V. Advanced Securement (9132) dressing and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference. | Device | Intervention |
| Standard bordered polyurethane dressingAlso: Tegaderm™ IV Advanced (1682 or 1683)PIVCs will be dressed and secured as per standard practice at the participating sites * RBWH and PUH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1683) and non-sterile tape strip over extension tubing. * QCH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1682 or 1683) and secured with tubular bandage +/- arm board and non-sterile stretchy tape if PIVC over flexible joint, +/- tissue adhesive as per clinician preference. | Device | Control |
Primary outcome
Feasibility for a definitive RCT
Time frame: On completion of 300 participants
The feasibility of conducting a definitive RCT will be assessed against the following criteria: i. Study Eligibility as per inclusion/exclusion criteria (≥80% of screened participants will be eligible for study inclusion) ii. Participant Recruitment onto study (≥80% of eligible participants will provide informed consent to participate in the study) iii. Retention of study participants (<10% will be lost to follow up) iv. Protocol fidelity of study participants (≥80% will receive the allocated intervention) v. Missing data for primary outcome 2 (<5% of primary outcome 2 data will be unable to be collected) vi. Satisfaction of participants/parents and staff (<10% report "low" satisfaction with the intervention arm (rated low/medium/high) vii. An estimate of catheter-related infectious complications (defined as per primary outcome 2) in the control group that indicate a fully powered multi-site RCT is achievable
Catheter-related infectious complications and phlebitis
Time frame: Daily until 48hours after study PIVC is removed.
Proportion of patients with a composite measure of PIVC Colonization; PIVC local infection; PIVC-associated Bloodstream Infection (BSI) and Phlebitis. These measures are defined below in secondary outcomes. If patients meet more than one of the following [e.g., phlebitis and PIVC local infection], both will be collected however only counted once for the composite measure.
12 secondary outcomes
PIVC tip colonization
Time frame: Daily until 48hours after study PIVC is removed.
PIVC local infection without Bloodstream Infection (BSI)
Time frame: Daily until 48hours after study PIVC is removed.
PIVC-associated Bloodstream Infection
Time frame: Daily until 48hours after study PIVC is removed.
Phlebitis
Time frame: Daily until 48hours after study PIVC is removed.
PIVC device failure
Time frame: Daily until 48hours after study PIVC is removed.
Dressing durability
Time frame: Daily until study PIVC is removed.
Skin colonization
Time frame: On study PIVC removal
Adverse skin event
Time frame: Daily until 48hours after study PIVC is removed.
Serious adverse event
Time frame: Daily until 48hours after study PIVC is removed.
Cost effectiveness
Time frame: Until discharge.
Patient reported experience measures of the dressing
Time frame: Daily until 48hours after study PIVC is removed.
Clinician reported experience measures of the dressing including application and removal
Time frame: Daily until 48hours after study PIVC is removed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 42186074Drugeon B, Ball DL, Kleidon TM, O'Brien C, Mihala G, Marsh N, Ullman A, Corley A, Schults JA, Guenezan J, McCarthy K, Seguin S, Batiot G, Byrnes J, Silva TL, Mimoz O, Rickard CM. An international randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial). Antimicrob Resist Infect Control. 2026 May 25;15(1):94. doi: 10.1186/s13756-026-01767-y.
- Derived from this study: PubMed 39013653Rickard CM, Drugeon B, Ullman A, Marsh NM, Corley A, Ball D, O'Brien C, Kleidon TM, Guenezan J, Couvreur R, McCarthy KL, Seguin S, Batiot G, Byrnes J, Schults J, Zahir SF, Mimoz O. Protect peripheral intravenous catheters: a study protocol for a randomised controlled trial of a novel antimicrobial dressing for peripheral intravenous catheters (ProP trial). BMJ Open. 2024 Jul 16;14(7):e084313. doi: 10.1136/bmjopen-2024-084313.
- Individual participant dataSharing planned: Yes. Available to individuals who provide a methodologically sound proposal and at the discretion of the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Rickard principal investigator
The University of Queensland
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine gluconate impregnated bordered polyurethane dressing and Standard bordered polyurethane dressing in people with Vascular Access Complication and Device Related Infection, run by The University of Queensland at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility for a definitive RCT (time frame: On completion of 300 participants). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05741866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.