Clinical trial NCT06384469: The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
Official title: The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rhinoplasty
Nasal Skin-soft Tissue Envelope Metabolism
Lactic Acid
Autologous Cartilage Grafting
Keywords: Open rhinoplasty approach
Closed rhinoplasty approach
Lactic acid
Skin-soft tissue envelope
Metabolism
Autologous cartilage grafting
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing primary functional rhinoplasty who comply with the study
* Adult patients undergoing primary functional rhinoplasty who have singed the informed consent, previously approved by the ethics commitee.

Exclusion Criteria: -

* patients with previous surgical procedures to the nose
* patients with greater previous injury or burns to the nasal skin
* patients with autoimmune skin conditions
* patients with significant cardiovascular diseases
* patients unwilling to comply with the study
* patients who do not want to sign the informed consent, previously approved by the ethics commitee.

Primary outcomes:
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
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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UHC Sestre milosrdnice
name: Marko Velimir Grgić, MD, PhD
role: STUDY_CHAIR
References: