RhinoplastyNCT06384469
The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism
An observational study of Rhinoplasty and Nasal Skin-soft Tissue Envelope Metabolism, run by University Hospital Sestre Milosrdnice.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinoplasty, Nasal Skin-soft Tissue Envelope Metabolism, Lactic Acid
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2025to 1 Sep 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: immediately after the surgical procedure and 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateo Čukman, University Hospital Sestre Milosrdnice
- Investigators
- Marko Velimir Grgić, MD, PhD, Study chair, UHC Sestre milosrdnice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384469
- Sponsor's protocol ID
- 98984697615
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not to be shared with other researchers.