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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity Hospital Sestre Milosrdnice

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Patients undergoing open rhinoplasty approach
Group B: Patients undergoing closed approach rhinoplasty.

Trial outcomes

Primary outcomes

1

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.

Time frame
immediately after the surgical procedure and 7 days after the procedure
2

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.

Time frame
immediately after the surgical procedure and 7 days after the procedure

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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