Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT06384469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2024-04-22', 'studyFirstSubmitQcDate': '2024-04-22', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach', 'timeFrame': 'immediately after the surgical procedure and 7 days after the procedure', 'description': 'In participants undergoing primary functional rhinoplasty, the capillary blood lactic acid concentration from the skin-soft tissue envelope will be assessed by using Statstrip lactate measuring device and Statstrip test strips immediately after the procedure and 7 days after the procedure.'}, {'measure': 'Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope', 'timeFrame': 'immediately after the surgical procedure and 7 days after the procedure', 'description': 'In the same participants undergoing different rhinoplasty approach, the volume of the used autologous cartilage grafts will be measured by using water displacement method, and this result will be correlated with the capillary blood lactic acid concentration from the skin-soft tissue envelope.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open rhinoplasty approach', 'Closed rhinoplasty approach', 'Lactic acid', 'Skin-soft tissue envelope', 'Metabolism', 'Autologous cartilage grafting'], 'conditions': ['Rhinoplasty', 'Nasal Skin-soft Tissue Envelope Metabolism', 'Lactic Acid', 'Autologous Cartilage Grafting']}, 'descriptionModule': {'briefSummary': 'This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure.\n\nThe aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism.', 'detailedDescription': "This is a prospective observation cohort investigation.100 adult participants undergoing primary functional rhinoplasty between the January 2nd 2025 and January 2nd 2026 will be assessed in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure. Prior to conducting the investigation, the participants will need to sign an informed consent for participating in the study, which would be previously approved by the ethics committee. For measuring capillary blood lactic acid concentration investigators are to use StatStrip® Lactate device and test strips. The volume of the used autologous cartilage autografts will be measured as well by using the water displacement method. Other used information regarding demographics and operation details will be drawn from the hospital's information systems, to which only medical personnel has an access. Using statistical analysis investigators are to perform the independent samples t-test, that is the Mann-Whitney U test, to analyze whether or not there is a difference in lactic acid concentration in participants undergoing open vs closed rhinoplasty approach. Furthermore by using Person's correlation coefficient method, the correlation between the used autologous cartilage grafts volume and lactate concentration will be assessed. The results of the lactic acid concentration will be interpreted with an assistance of the medical biochemistry and laboratory medicine specialist.\n\nThe aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism.\n\nSince the investigation is to be performed during the regular working hours and since there is no intervention, no external funding will be necessary."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients between 18 and 80 years of age, scheduled for primary functional rhinoplasty, who are willing to comply with the study and sign the informed consent, previously approved by the ethics commitee.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing primary functional rhinoplasty who comply with the study\n* Adult patients undergoing primary functional rhinoplasty who have singed the informed consent, previously approved by the ethics commitee.\n\nExclusion Criteria: -\n\n* patients with previous surgical procedures to the nose\n* patients with greater previous injury or burns to the nasal skin\n* patients with autoimmune skin conditions\n* patients with significant cardiovascular diseases\n* patients unwilling to comply with the study\n* patients who do not want to sign the informed consent, previously approved by the ethics commitee.'}, 'identificationModule': {'nctId': 'NCT06384469', 'briefTitle': 'The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Sestre Milosrdnice'}, 'officialTitle': 'The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism', 'orgStudyIdInfo': {'id': '98984697615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing open rhinoplasty approach', 'description': 'Patients undergoing open rhinoplasty approach, of which most of will be augmented by using autologous cartilage grafts.'}, {'label': 'Patients undergoing closed approach rhinoplasty.', 'description': 'Patients undergoing closed approach rhinoplasty of which only few will be augmented by using autologous cartilage grafts.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mateo Čukman, MD', 'role': 'CONTACT', 'email': 'mateo.cukman@hotmail.com', 'phone': '+385992642621'}, {'name': 'Marko Velimir Grgić, MD, PhD', 'role': 'CONTACT', 'email': 'marko_grgic@yahoo.com', 'phone': '+385993787059'}], 'overallOfficials': [{'name': 'Marko Velimir Grgić, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UHC Sestre milosrdnice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data are not to be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Sestre Milosrdnice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor, resident', 'investigatorFullName': 'Mateo Čukman', 'investigatorAffiliation': 'University Hospital Sestre Milosrdnice'}}}}