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临床试验/NCT04906967
NCT04906967Unknown不适用

A Comparative Study of Modified Sural Flap and Anterolateral Thigh Flap in Soft Tissue Reconstruction of Lower Extremity

Sohag University0 个研究点目标入组 32 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
32
主要终点
Viability of the flap

研究概览

简要总结

The aim of the study is to evaluate the outcomes of coverage of soft tissue defects of leg and foot by modified sural flap versus anterolateral thigh flap

详细描述

The leg and foot contain a thin subcutaneous layer and few muscles, thus the tibia and tendons can easily become exposed due to trauma. Therefore leg and foot injuries are often associated with a loss of soft tissues and exposed fractures.

one of the following reconstructive options are chosen:

  1. The defect is allowed to heal by secondary intention.
  2. The wound is closed primarily.
  3. A split or full thickness skin graft and or neodermis is applied.
  4. A local random flap or propeller flap is transposed or advanced.
  5. A pedicled or island flap is transferred.
  6. A microvascular free flap is transferred. The method of soft tissue reconstruction chosen hinges on the patient's medical condition, the surgeon's experience, the size of the wound, the vascular status of the foot and the exposed structures the skin in this region has low flexibility and the subcutaneous circulation does not allow the use of long randomized flaps, the task of finding flaps to cover bones or tendons in wounds with cutaneous loss in the legs and feet is difficult.

The sural flap acts as an axial flap and has 3 sources of nutrition,the vascular plexus of the deep fascia, the medial superficial sural artery which follows the medial sural nerve and the arteries that follow the minor saphenous vein. Venous return is ensured by the minor saphenous vein which may be used as a distal pedicle to provide reverse flow.

sural flap has the advantages of easy and quick harvesting without sacrificing major arteries and can be done in one stage operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • •• patients aging 5 to 70 years.
  • •Defect at the lower leg ,ankle or foot
  • •Palpable distal pulse

排除标准

  • •• Peripheral vascular disease
  • •Underling bone osteomyelitis
  • •Unhealthy skin of posterior or lateral aspect of leg.
  • •Vascular injury.
  • •Patients with chronic diseases
  • •Patients associated with vital organ injuries
  • •Patients unfit to surgery

研究组 & 干预措施

modified sural flap

Active Comparator

modified sural flap used to cover soft tissue defect around ankle

干预措施: flaps (Procedure)

anterolateral thigh flap

Active Comparator

anterolateral thigh flap used to cover soft tissue defect around ankle

干预措施: flaps (Procedure)

结局指标

主要结局

Viability of the flap

时间窗: baseline

Viability of flap detected by numbers of flap survived in each group

Resistance to infection

时间窗: Baseline

Detected by numbers of flabs in each group that resist infection

Size of defect covered(size of the flap)

时间窗: Baseline

Detected by measuring the length and width in cms

次要结局

未报告次要终点

研究者

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

Ahmed Faisal Esmael Mahmoud

Assistant lecturer in orthopedic department,faculty of medicine,sohag university,Sohag Governorate

Sohag University

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