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临床试验/NCT04974918
NCT04974918Unknown不适用

The Reliability and Versatility of Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of Lip Defects

Sohag University0 个研究点目标入组 20 人开始时间: 2021年7月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
change of donor site scar

研究概览

简要总结

Nasolabial flaps have limited mobility and may need two stages, mostly for intraoral defects .The facial artery perforator-based flap is the first true perforator flap in the face. It allows one-stage reconstruction and allows freedom in flap design.

The nasolabial perforator flap has certain advantages such as repair using a similar tissue, a wider rotation arc around the pedicle compared to the other regional flaps, and the primary closure of the donor area.

详细描述

Recently, perforator flaps have become popular in many areas of reconstructive surgery. They provide design freedom and reduce donor-site morbidity. Many traditional local flaps including nasolabial flaps are based on the use of the axial facial artery with multiple perforators. Flaps based on one perforator of the facial artery have been introduced and are used more frequently because of their advantages over perforator flaps.

According to recent literatures, facial artery provides numerous cutaneous perforators, on which skin flaps can be islanded, with greater mobility and liability for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage. .

Multiple perforators along the facial artery, a mean of 4 on each half of the face (range: 2-8), with a mean diameter of 0.94 mm (range: 0.53-1.36 mm) and maximum perforators between 20 and 60 mm from the origin along the length of the facial artery. This roughly corresponds to an area near the angle of the mouth around the nasolabial fold. A local skin flap based on such perforators can be islanded, with greater freedom in flap designing for reconstruction of small-to-moderate-sized intraoral and facial defects in one stage Ethical consideration This study will be approved by the ethics committee of Faculty of Medicine Sohag University. A written informed consent will be taken from every patient that will be included in this study and all patients will be informed about the nature & the aim of the study and the possibility of any complication.

Surgical technique:

After tumor ablation the facial artery perforator along the nasolabial fold was found and marked with a handheld Doppler probe. A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement. For protection against shear forces, the investigators left a small cuff of subcutaneous fat around the perforator

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lip defect more than half of lip
  • Patients aging 7 to 70 years

排除标准

  • Lip defect less than half of lip
  • Patients with a major uncontrollable medical illness, chronic heavy smokers

结局指标

主要结局

change of donor site scar

时间窗: one year

the possibility of a one-stage reconstruction and customization. In addition, the use of this flap increases aesthetic results, as it uses a local flap and conceals the donor scar within a natural fold. prevent furthur operations for reconstructions. We use( 0..100 visual analog scale) to show change of skin texture to basal line as 0 is the worst result and 100 the best ...patient questionnaire about the result will be done

次要结局

  • change of lip size(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aya Ahmed Ahmed

resident doctor at plastic surgery sohag university hospital

Sohag University

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