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临床试验/NCT06384469
NCT06384469尚未招募不适用

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

University Hospital "Sestre Milosrdnice"0 个研究点目标入组 100 人开始时间: 2025年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope

时间窗: 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.

Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital "Sestre Milosrdnice"
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mateo Čukman

medical doctor, resident

University Hospital "Sestre Milosrdnice"

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