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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach [Срок оценки: 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 [Срок оценки: immediately after the surgical procedure and 7 days after the procedure]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06384469 · 98984697615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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