Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2025-12-29 @ 6:26 AM
Study NCT ID:
NCT05741866
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016459', 'term': 'Prosthesis-Related Infections'}, {'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010689', 'term': 'Phlebitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the intervention, blinding of patients/clinicians to the intervention is not possible. However, the statistician will be blinded for analysis; and the microbiologist and laboratory staff will also be blinded to treatment allocation when apportioning infection outcomes.\n\nAdditionally, at the completion of Phase 1 (n=300) an independent data safety monitoring committee (DSMC) comprised of a biostatistician, physician and expert trialist, will review pre-defined blinded analyses, conducting a review of feasibility and safety data to determine if the trial should continue to a fully powered RCT.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A multi-centre, two-arm, parallel group adaptive randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility for a definitive RCT', 'timeFrame': 'On completion of 300 participants', 'description': 'The feasibility of conducting a definitive RCT will be assessed against the following criteria:\n\ni. 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'}, {'measure': 'Catheter-related infectious complications and phlebitis', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': '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.\n\nIf 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.'}], 'secondaryOutcomes': [{'measure': 'PIVC tip colonization', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': '\\>15 cfu of a pathogen semi-quantitative method, or ≥1000 cfu of a pathogen per mL broth method.\n\nPIVC tips will be collected based on Nurse and laboratory availability at time of PIVC removal.'}, {'measure': 'PIVC local infection without Bloodstream Infection (BSI)', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': '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.\n\nCollected 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.'}, {'measure': 'PIVC-associated Bloodstream Infection', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': 'Proportion of patients with a laboratory Confirmed Bloodstream Infection, as defined by NHSN 2021 adult and infant criteria\n\nCollected 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.'}, {'measure': 'Phlebitis', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': 'Either pain or tenderness \\[\\>1 on a scale of 0 to 10\\]), or at least 2 of erythema, swelling, purulence or palpable cord.\n\nCollected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.'}, {'measure': 'PIVC device failure', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': '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).\n\nCollected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.'}, {'measure': 'Dressing durability', 'timeFrame': 'Daily until study PIVC is removed.', 'description': 'Proportion of patients with dressing durability assessed as:\n\n(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).\n\nCollected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.'}, {'measure': 'Skin colonization', 'timeFrame': 'On study PIVC removal', 'description': 'Reported semi-quantitatively as scant, 1+, 2+, 3.\n\nPIVC skin swabs will be collected based on Nurse and laboratory availability at time of PIVC removal.'}, {'measure': 'Adverse skin event', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': '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).\n\nCollected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.'}, {'measure': 'Serious adverse event', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': 'Proportion of patients with anaphylactic reaction to CHG in dressing; or mortality related to PIVC infection.\n\nCollected daily by either research nurse or medical investigators from either direct observation, consultation with the clinical staff or review of the medical record.'}, {'measure': 'Cost effectiveness', 'timeFrame': 'Until discharge.', 'description': "Direct and indirect healthcare costs to the health system, including cost per complication avoided.\n\nCollected 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.\n\nA 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."}, {'measure': 'Patient reported experience measures of the dressing', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': 'Proportion of participants/parents who report their satisfaction with the dressing rated low/medium/high with respective prompts of:\n\n1. "I\'d rather use a different dressing next time"\n2. "The dressing was ok, but I\'m happy to try other types"\n3. "It was a really good dressing and I\'d like to use this one again"\n\nA Patient-Reported Experience Measure survey will be conducted on study PIVC removal.\n\nPatient\'s will have the opportunity to comment on the dressing and their satisfaction with it at any time during study participation.'}, {'measure': 'Clinician reported experience measures of the dressing including application and removal', 'timeFrame': 'Daily until 48hours after study PIVC is removed.', 'description': 'Proportion of clinicians who report their satisfaction with the dressing rated low/medium/high with respective prompts of:\n\n1. "I\'d rather use a different dressing next time"\n2. "The dressing was ok, but I\'m happy to try other types"\n3. "It was a really good dressing and I\'d like to use this one again"\n\nCollected opportunistically between dressing application to 48 hours after study PIVC removal.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Peripheral Intravenous Catheter', 'PIVC', 'Intravenous', 'Vascular access device', 'randomised controlled trial', 'phlebitis', 'chlorhexidine gluconate', 'CHG dressing'], 'conditions': ['Vascular Access Complication', 'Device Related Infection', 'Device Related Sepsis', 'Device Site Reactions', 'Catheter Infection', 'Catheter Complications', 'Catheter-Related Infections', 'Catheter Related Complication', 'Occlusive Dressings', 'Wound Infection', 'Wound of Skin', 'Wound']}, 'referencesModule': {'references': [{'pmid': '39013653', 'type': 'DERIVED', 'citation': "Rickard 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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Study Feasibility\n* Occurrence of infectious complications related to the PIVC\n\nParticipants will be randomly allocated to receive either of the below dressings to cover and secure their PIVC:\n\n* The standard dressing used at their hospital, or\n* The intervention dressing which has Chlorhexidine gluconate (CHG) on it\n\nResearchers will compare standard and CHG dressings to see if the presence of CHG improves the occurrence of infectious complications related to the PIVC.', 'detailedDescription': "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.\n\nSetting and sample:\n\nAustralia: 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).\n\nFrance: 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.\n\nSample size:\n\nPhase 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).\n\nPhase 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PIVC to be inserted with expected dwell \\>48 hours\n* Provided written and informed consent (patient or carer)\n\nAustralia only\n\n• ≥6 years of age (due to size of dressing)\n\nFrance only\n\n• ≥18 years of age\n\nExclusion Criteria:\n\n* Burned, non-intact or scarred skin at the insertion site\n* Known allergy to CHG or transparent dressing adhesives\n* Palliative care patients on end-of-life pathway\n* Patient who has already participated in the study\n* Placement of a PIVC in an emergency, that does not allow the usual rules of hygiene for insertion to be adhered to.\n\nAdditional exclusions to Australian study only\n\n* Non-English-speaking patients without interpreter\n* Under the care of Child and Family Services and unable to gain consent from case worker (paediatric patients)\n\nAdditional exclusions to French study only\n\n* Patients not benefiting from the French Social Security scheme or not benefiting from it through a third party,\n* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.\n* Known pregnant or breastfeeding women\n* Predictably difficult vascular access (IV drug addiction, obesity)'}, 'identificationModule': {'nctId': 'NCT05741866', 'acronym': 'ProP', 'briefTitle': 'Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'Protect PIVCs: An Adaptive Randomized Controlled Trial of a Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs).', 'orgStudyIdInfo': {'id': '2022/HE001952'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Bordered Polyurethane Dressing', 'interventionNames': ['Device: Standard bordered polyurethane dressing']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'CHG Bordered Polyurethane Dressing', 'interventionNames': ['Device: Chlorhexidine gluconate impregnated bordered polyurethane dressing']}], 'interventions': [{'name': 'Chlorhexidine gluconate impregnated bordered polyurethane dressing', 'type': 'DEVICE', 'otherNames': ['Tegaderm™ Antimicrobial I.V. Advanced Securement (9132)'], 'description': 'PIVCs will be dressed and secured at the participating sites\n\n* 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.\n* 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.', 'armGroupLabels': ['Intervention']}, {'name': 'Standard bordered polyurethane dressing', 'type': 'DEVICE', 'otherNames': ['Tegaderm™ IV Advanced (1682 or 1683)'], 'description': 'PIVCs will be dressed and secured as per standard practice at the participating sites\n\n* RBWH and PUH: Bordered polyurethane dressing (Tegaderm™ IV Advanced 1683) and non-sterile tape strip over extension tubing.\n* 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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'ProP - Project Manager', 'role': 'CONTACT', 'email': 'catherine.obrien2@health.qld.gov.au', 'phone': '+61 (0) 7 36467671'}, {'name': 'Nicole Marsh', 'role': 'CONTACT', 'email': 'nicole.marsh@health.qld.gov.au', 'phone': '+61 (0) 7 36468590'}, {'name': 'Nicole Marsh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amanda Corley, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kate McCarthy, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Catherine O'Brien", 'role': 'SUB_INVESTIGATOR'}], 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Tricia Kleidon', 'role': 'CONTACT', 'email': 'tricia.kleidon@health.qld.gov.au', 'phone': '+61 (0) 7 30683827'}, {'name': 'Amanda Ullman', 'role': 'CONTACT', 'email': 'a.ullman@uq.edu.au', 'phone': '+61 400 553 709'}, {'name': 'Amanda Ullman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tricia Kleidon', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': '86000', 'city': 'Poitiers', 'state': 'Nouvelle-Aquitaine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand Drugeon', 'role': 'CONTACT', 'email': 'bertrand.drugeon@chu-poitiers.fr'}, {'name': 'Olivier Mimoz', 'role': 'CONTACT', 'email': 'olivier.mimoz@chu-poitiers.fr'}, {'name': 'Olivier Mimoz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeremy Guenezam', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bertrand Drugeon', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raphael Couvreur', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sabrina Seguin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'centralContacts': [{'name': 'ProP - Project Manager', 'role': 'CONTACT', 'email': 'catherine.obrien2@health.qld.gov.au', 'phone': '+61 (0) 7 36467671'}, {'name': 'Daner Ball', 'role': 'CONTACT', 'email': 'd.ball@uq.edu.au', 'phone': '+61 (7) 3346 6077'}], 'overallOfficials': [{'name': 'Claire Rickard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Queensland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Available to individuals who provide a methodologically sound proposal and at the discretion of the Principal Investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'collaborators': [{'name': "Queensland Children's Hospital", 'class': 'OTHER_GOV'}, {'name': "Royal Brisbane and Women's Hospital", 'class': 'OTHER_GOV'}, {'name': 'University Hospital of Poitiers', 'class': 'UNKNOWN'}, {'name': 'Griffith University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}