Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT03508492
Status:
UNKNOWN
Last Update Posted:
2018-04-25
First Post:
2018-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Surgeon's global satisfaction with the applicators.", 'timeFrame': 'Intraoperative', 'description': 'Using an analog visual scale we will record the total score, over a maximum of 80 points, that assess the following quality aspects of the applicators:\n\n* Satisfaction with the presentation of the product\n* Satisfaction with the simplicity of activation\n* Satisfaction with the mix of the different components of the product\n* Satisfaction with the comfort of product use\n* Satisfaction with the surface covered by an applicator\n* Satisfaction with the shape of the applicator for painting areas of difficult access\n* Satisfaction with the drying time of the product\n* Satisfaction with the area delimited with the use of the product'}, {'measure': 'Qualities of each applicators', 'timeFrame': 'Intraoperative', 'description': 'Using an analog visual scale, were one end represents "totally disagree" and the other "totally agree" (0-10 points), we will record the score of each of the following quality aspects of the applicators:\n\n* Satisfaction with the presentation of the product\n* Satisfaction with the simplicity of activation\n* Satisfaction with the mix of the different components of the product\n* Satisfaction with the comfort of product use\n* Satisfaction with the surface covered by an applicator\n* Satisfaction with the shape of the applicator for painting areas of difficult access\n* Satisfaction with the drying time of the product\n* Satisfaction with the area delimited with the use of the product'}], 'secondaryOutcomes': [{'measure': 'Costs of using the applicators', 'timeFrame': 'Through study completion, an average of 3 months'}, {'measure': 'Adhesion to preoperative measures to avoid surgical site infections (SSI)', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Analyze the verification check list for surgical site infection preoperative prevention. This check list has been provided by the Preventive Medicine, Public Health and Hygiene Spanish Society as part of the Zero Surgical Site Infection Protocol.\n\nThis verification check list includes indicators of:\n\n* Antibiotic prophylaxis\n* Intraoperative Alcoholic Chlorhexidine application\n* Hair removal from the surgical site\n* Normotherapy\n* Glycemic control'}, {'measure': 'Surgical site infection incidence', 'timeFrame': 'During the first 30 to 90 days after surgery, according to the SSI prevention protocol'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Satisfaction', 'Product Quality']}, 'descriptionModule': {'briefSummary': "The development of surgical site infections (SSI) in clean-contaminated surgery is regarded as being preventable. Known to be effective in the prevention of surgical site infection are the adequate sterilization of the surgical instruments, asepsis during operation, antibiotic prophylaxis where indicated, and certainly the preparation of the skin at the incision site. During the last decades the use of alcoholic chlorhexidine has replaced povidone iodine for preoperative skin preparation. In order to improve the way alcoholic chlorhexidine is applied, pharmaceutical industry has developed new applicators.\n\nThis randomized study was conducted to know the surgeons' satisfaction within the use of two tinted applicators: Chloraprep® and Nex Clorex 2%"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer surgeons from colon, cardiac, knee and hip surgical departments. Once surgeon has enrolled the study, patients will be selected if they have hospital admission with scheduled surgery and have signed informed consent\n\nExclusion Criteria:\n\n* Urgent surgeries\n* Outpatient surgery\n* Surgical complex cures\n* Mixed interventions: exploratory or sequential\n* Unscheduled surgeries\n* Rejection of participation\n* Chlorhexidine or isopropyl alcohol hypersensibility patients\n* If any patients changed its mind after signing the informed consent will be removed from the study.'}, 'identificationModule': {'nctId': 'NCT03508492', 'briefTitle': "Surgeons' Satisfaction With Two Types of Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)", 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Comparative Study to Asses the Satisfaction With Tinted Chlorhexidine Applicators (Chloraprep® and Nex Clorex 2%)', 'orgStudyIdInfo': {'id': 'CA-IQZ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Knee surgeons', 'description': 'Four knee surgeons', 'interventionNames': ['Other: Surgical tinted Chloraprep® applicators', 'Other: Surgical tinted Nex Clorex 2% applicators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hip surgeons', 'description': 'Six hip surgeons', 'interventionNames': ['Other: Surgical tinted Chloraprep® applicators', 'Other: Surgical tinted Nex Clorex 2% applicators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cardiac surgeons', 'description': '6 cardiac surgeons', 'interventionNames': ['Other: Surgical tinted Chloraprep® applicators', 'Other: Surgical tinted Nex Clorex 2% applicators']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colon surgeons', 'description': '6 colon surgeons', 'interventionNames': ['Other: Surgical tinted Chloraprep® applicators', 'Other: Surgical tinted Nex Clorex 2% applicators']}], 'interventions': [{'name': 'Surgical tinted Chloraprep® applicators', 'type': 'OTHER', 'description': 'We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.', 'armGroupLabels': ['Cardiac surgeons', 'Colon surgeons', 'Hip surgeons', 'Knee surgeons']}, {'name': 'Surgical tinted Nex Clorex 2% applicators', 'type': 'OTHER', 'description': 'We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.', 'armGroupLabels': ['Cardiac surgeons', 'Colon surgeons', 'Hip surgeons', 'Knee surgeons']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cristina Fernandez Perez, Ph D.', 'role': 'CONTACT', 'email': 'cfernandezp@salud.madrid.org', 'phone': '+34913303430'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cristina Fernandez Perez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Preventive and Public Health Department', 'investigatorFullName': 'Cristina Fernandez Perez', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}