Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-22
Brief Title:
The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
Sponsor:
University Hospital Sestre Milosrdnice
Organization:
University Hospital Sestre Milosrdnice
Study Overview
Official Title:
The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
The 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
The 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
Detailed Description:
This is a prospective observation cohort investigation100 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 hospitals 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 Persons 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
The 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
Since the investigation is to be performed during the regular working hours and since there is no intervention no external funding will be necessary
The 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
Since the investigation is to be performed during the regular working hours and since there is no intervention no external funding will be necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None