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临床试验/NCT03735641
NCT03735641Unknown不适用

Evaluation of the Postoperative Effect of Expanded Pedicled Deltopectoral Flap to Repair the Facial-Cervical Scars

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Flap Color(the value of L*a*b*)

研究概览

简要总结

This study evaluates the effect of Expanded Pedicled Deltopectoral Flap on facial-cervical scars repair, including flap sensation, L*a*b* value,flap's elasticity,melanin content, hemoglobin content, and evaluation of scar and patient, doctor, and third-party satisfaction

详细描述

The scars of face and neck caused by burning often show as large faciocervical scar.Important areas of current focus in face and neck scars management are functional outcomes and quality of patient life.The deltopectoral flap was first described by Bakamjian in 1965, and was recognized as one of the first choices for facial reconstruction, as the texture, color of the flap skin is similar to the facial skin. Since the tissue expansion technique was used to the flap, the flap became one of the best choices for the facial defect reconstruction,especially for Asian patients. It can be used with pedicled or free transferred.Complications at the donor or recipient site have been widely reported and often include dilator exposure,the flap blood circulation disorder and delayed healing, but the pattern of sensory recovery ,flap's elasticitycolor change have been studied less well.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -
  • In compliance with ethical requirements, patients were voluntarily tested and signed informed consent.

排除标准

  • Peripheral neuropathy
  • Serious aphasia or cognitive impairment, and first-degree relatives can not get in touch.
  • Can not follow up
  • Allergic constitution
  • Connective tissue disease
  • Hormone or chemotherapy drugs are being used.

结局指标

主要结局

Flap Color(the value of L*a*b*)

时间窗: 3 month later

The Antera 3D is a camera for image acquisition and analysis of the skin.Every color is expressed in a three-dimensional coordinate system in terms of three units. L\* expresses the luminance and gives the relative brightness of the color ranging from total black (L\* ¼ 0) to total white (L\* ¼ 100).The terms a\* and b\* are coordinates of chromaticity, with a\* representing the balance between green (negative values)and red (positive values) and b\* representing the balance between blue (negative values) and yellow (positive values)

次要结局

  • Flap Elasticity(3 month later)
  • Melanin Content(3 month later)
  • Satisfaction questionnaire(3 month later)
  • Scar scaling(6 month later)
  • Hemoglobin Content(3 month later)
  • Temperature(3 month later)
  • Two-point Discrimination(2PD)(3 month later)
  • Light Touch(3 month later)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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