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

April 25, 2024 updated by: Mateo Čukman, University Hospital "Sestre Milosrdnice"

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach
Time Frame: immediately after the surgical procedure and 7 days after the procedure
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
Time Frame: immediately after the surgical procedure and 7 days after the procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital "Sestre Milosrdnice"

Investigators

  • Study Chair: Marko Velimir Grgić, MD, PhD, UHC Sestre Milosrdnice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 2, 2025

Primary Completion (Estimated)

January 2, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 98984697615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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