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临床试验/NCT03483480
NCT03483480Unknown不适用

Randomized Controlled Trial of Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

The National Children's Hospital, Tallaght2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
2
主要终点
Time to complete wound healing

研究概览

简要总结

Pilonidal Disease is disease of young patients with significant morbidity and is difficult to treat. Currently multiple methods are practiced for the treatment of the disease, two of them are preferred over others and practice extensively. First one involves excision of pilonidal sinus and dressings while the second one is excision of the pilonidal sinus with application of negative pressure wound therapy. None of these approaches is considered superior to the other, as not enough comparison studies of the two procedures have been done. In order to clarify this and find the best option for our patients, investigators are taking opportunity to compare these two modalities. If participants choose to participate in this study they will be randomly selected to one of these groups and the progress of wound healing will be monitored after surgery with the measurement of wound weekly and photographs. Investigators are hoping to find out which procedure is superior. This will allow investigators to provide the best treatment option for their patients in future.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient suffering from Pilonidal Disease willing to participate in study.

排除标准

  • Patients below the age of 16 years (not able to consent).
  • Not consenting to participate in study.
  • Patient with less than 3 cm between inferior opening of sinus and anus.

结局指标

主要结局

Time to complete wound healing

时间窗: Wound will be assessed for healing at 1 week to 6 weeks

Time between Surgery and complete healing when there is no further requirement to apply dressing

次要结局

  • VAS score (Visual Analogue Scale)(VAS for pain will be recorded at 1 week to 6 weeks at weekly intervals)
  • Analgesia Requirement(Recording will be done at 1 week to 6 weeks at weekly intervals)
  • Wound size ratio(Wound size ratio will be recorded at 1 week to 6 weeks at weekly intervals)
  • Time to resume daily activities(Assessment will be done at 1 week to 6 weeks at weekly intervals)
  • Recurrence(Patient will be assessed at 6 months from surgery)

研究者

发起方
The National Children's Hospital, Tallaght
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasir Bashir

Assistant Professor of Surgery

The National Children's Hospital, Tallaght

研究点 (2)

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