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

NCT06384469 | Not Yet Recruiting

• 1 other identifier: 98984697615
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients undergoing open rhinoplasty approach

Patients undergoing open rhinoplasty approach, of which most of will be augmented by using autologous cartilage grafts.

Patients undergoing closed approach rhinoplasty.

Patients undergoing closed approach rhinoplasty of which only few will be augmented by using autologous cartilage grafts.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Officials

• Marko Velimir Grgić, MD, PhD

  UHC Sestre milosrdnice

  STUDY CHAIR

Central Study Contacts

Mateo Čukman, MD

CONTACT

+385992642621; mateo.cukman@hotmail.com

Marko Velimir Grgić, MD, PhD

CONTACT

+385993787059; marko_grgic@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, resident

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: January 2, 2025
• Primary Completion: January 2, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share