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临床试验/NCT02574936
NCT02574936已完成不适用

Effects of Reduction Dead Space Volume With Karydakis Modification

Siverek Devlet Hastanesi0 个研究点目标入组 80 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery

研究概览

简要总结

The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.

详细描述

The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.

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
18 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years
  • patients who accept the procedure
  • chronic p.sinüs disease

排除标准

  • previous sinüs surgery
  • active infection
  • patients who did not accept the procedure
  • patients under age of 18.

结局指标

主要结局

Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery

时间窗: 18 months

OUTCOME MEASURE: 1. Extracted sinus volume 2. The number of patients with complications 1. Delayed wound healing 2. seroma 3. hematoma formation 4. wound infection

次要结局

未报告次要终点

研究者

发起方
Siverek Devlet Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulcabbar Kartal

Principal Investigator

Siverek Devlet Hastanesi

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