The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism

Rhinoplasty Clinical Trial

Official title:

The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384469
• Other study ID #: 98984697615
• Status: Not yet recruiting
• Start date: January 2, 2025
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2024
• Source: University Hospital "Sestre Milosrdnice"
• Contact: Mateo Cukman, MD
• Phone: +385992642621
• Email: mateo.cukman[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2026
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinoplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach	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.	immediately after the surgical procedure and 7 days after the procedure
Primary	Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope	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.	immediately after the surgical procedure and 7 days after the procedure