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临床试验/NCT04430413
NCT04430413已完成不适用

Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method

Kafrelsheikh University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Assessment of the wound capacity

研究概览

简要总结

The aim of the study is to assess the healing promotion effect of platelet rich plasma in patient being operated for sacrococcygeal pilonidal sinus disease by open excision

详细描述

Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.

Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of age. It occurs rarely after the age of 45 and children.

Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle infection. The disease results from chronic infection of hair follicles and subsequent formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge through a midline sinus follow.

Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality of life and social function. These sinuses may become infected and present as acute abscesses. Management of these abscesses is uncontroversial and revolves around incision and drainage, however, the mode of surgical management of the chronic discharging sinus is variable, contentious, and problematic.

The Principles of Surgical strategies require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence. Many methods are available for surgical management of PNS which is treated by wide excision. After excision, the wound may be left open to heal with granulation tissue, or may be immediate closed with a midline closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is not yet a consensus on the optimal treatment.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age >18 years and <45 years.
  • All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).

排除标准

  • Pilonidal abscess.
  • Diabetic patient.
  • HGB < 10 g/dl.
  • Platelet count < 105/ul.
  • Anticoagulant treatment.
  • Wound cavity >35cc.

结局指标

主要结局

Assessment of the wound capacity

时间窗: One Year

Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.

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

Mohamed Gohar

Assistant Lecturer of General Surgery

Kafrelsheikh University

研究点 (2)

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