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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06384469
Enrollment
100
Registered
2024-04-25
Start date
2025-01-02
Completion date
2026-09-01
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autologous Cartilage Grafting, Lactic Acid, Nasal Skin-soft Tissue Envelope Metabolism, Rhinoplasty

Keywords

Open rhinoplasty approach, Closed rhinoplasty approach, Lactic acid, Skin-soft tissue envelope, Metabolism, Autologous cartilage grafting

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.

Interventions

None listed

Sponsors

University Hospital Sestre Milosrdnice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approachimmediately after the surgical procedure and 7 days after the procedureIn 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.
Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelopeimmediately after the surgical procedure and 7 days after the procedureIn 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.

Contacts

Primary ContactMateo Čukman, MD
mateo.cukman@hotmail.com+385992642621
Backup ContactMarko Velimir Grgić, MD, PhD
marko_grgic@yahoo.com+385993787059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026