Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-04 @ 6:45 AM
Study NCT ID:
NCT03417661
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2018-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-30', 'lastUpdatePostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of bacterial load at each test site.', 'timeFrame': '1 and 10 minutes after application.', 'description': 'Reduction in bacterial load of the test product in comparison to a negative control.'}], 'secondaryOutcomes': [{'measure': 'Persistence of reduction in bacterial load at each test site.', 'timeFrame': '30 minutes - 24 hours', 'description': 'Reduction in bacterial load of the test product in comparison to a negative control over a longer duration.'}, {'measure': 'Relative efficacy compared to a positive control', 'timeFrame': '1-10 minutes, and 30 minutes - 24 hours', 'description': 'To assess the reduction in bacterial load after application when compared to a similar commercially available product.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by a 5-point scale based on comment from the participant, and recorded assessments of erythema and oedema.', 'timeFrame': 'From application', 'description': 'Assessed by comments from the participant logged on a five-point scale, and recorded assessments of erythema and oedema by the investigator. Erythema and oedema are each assessed on a five-point scale of none to severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antimicrobial Effect']}, 'descriptionModule': {'briefSummary': 'This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a negative and a positive control product.', 'detailedDescription': 'HEXI-PREP by Clinell is a sterile single sachet wipe containing chlorhexidine gluconate and isopropyl alcohol. Both active ingredients are well-established ingredients commonly used for their disinfectant properties.\n\nThis trial is designed to assess the superiority of HEXI-PREP by Clinell Wipe against a negative control, and also to demonstrate the relative efficacy of HEXI-PREP by Clinell WIpe against a similar commercially available product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants 18 - 70 years, who have provided written informed consent to participate in the study\n* Test sites with a bacterial baseline count of ≥ 5.0 log10/cm2 at the inguinal (groin) test administration sites. ≥4.0 log10/cm2 at the abdominal test site and \\>3.0 log10/cm2 at the clavicular and/or median cubital regions at Day - 5 of screening\n* Participants, who in the opinion of the Investigator, are in suitable health for inclusion in the study.\n\nExclusion Criteria:\n\n* Exposure of the test sites to strong detergents, solvents or other irritants during the 14- day pre-test conditioning period or during the test period.\n* Use of systemic or topical antibiotic medications, steroid medications or any other product known to affect the normal microbial flora of the skin, up to 1 month prior to the screening period, during the 14-day pre-test conditioning period or during the test period.\n* Any known allergies to latex (rubber), alcohols, tape adhesives or to common antibacterial agents found in soaps, lotions or ointments, particularly chlorhexidine gluconate or chlorine.\n* Active skin rashes or breaks in the skin at the test site.\n* Active skin diseases or inflammatory skin conditions including contact dermatitis within 10cm of the test site.\n* Showering or bathing after the Day -5 baseline sampling and unwilling to refrain from showering or bathing whilst at Surrey CRC (Day 0 to Day 1).\n* Participation in another clinical trial within 90 days preceding randomisation.\n* Pregnant or breastfeeding women.\n* Any other medical condition, which in the opinion of the Investigator, should preclude participation.\n* Unwillingness to fulfil the performance requirements of the study.'}, 'identificationModule': {'nctId': 'NCT03417661', 'briefTitle': 'An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gama Healthcare Ltd.'}, 'officialTitle': 'An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes Versus Placebo and Chloraprep, for Use in Preoperative Skin Preparation', 'orgStudyIdInfo': {'id': 'GH001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEXI-PREP By Clinell Wipes vs Placebo', 'description': 'Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.', 'interventionNames': ['Drug: HEXI-PREP By Clinell Wipes', 'Drug: Placebos']}, {'type': 'EXPERIMENTAL', 'label': 'HEXI-PREP By Clinell Wipes vs Chloraprep', 'description': 'Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.', 'interventionNames': ['Drug: HEXI-PREP By Clinell Wipes', 'Drug: Chloraprep']}, {'type': 'EXPERIMENTAL', 'label': 'Chloraprep vs Placebo', 'description': 'Both trial products will be applied bilaterally to between one and four predetermined anatomical sites on each participant, depending on whether the inclusion criteria for bioburden has been met for each sampling site. Each site will be sampled for bacterial load at four predetermined time points.', 'interventionNames': ['Drug: Chloraprep', 'Drug: Placebos']}], 'interventions': [{'name': 'HEXI-PREP By Clinell Wipes', 'type': 'DRUG', 'description': 'Sterile single sachet wipe containing 3ml solution.', 'armGroupLabels': ['HEXI-PREP By Clinell Wipes vs Chloraprep', 'HEXI-PREP By Clinell Wipes vs Placebo']}, {'name': 'Chloraprep', 'type': 'DRUG', 'description': 'Sterile applicator containing 3ml solution.', 'armGroupLabels': ['Chloraprep vs Placebo', 'HEXI-PREP By Clinell Wipes vs Chloraprep']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'Sterile saline (0.9% w/v) wipe, containing 3ml of solution.', 'armGroupLabels': ['Chloraprep vs Placebo', 'HEXI-PREP By Clinell Wipes vs Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Surrey Clinical Research Centre', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Daryl Bendel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gama Healthcare Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}