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临床试验/NCT07552753
NCT07552753已完成不适用

Semi-occlusive Dressing Therapy for Pediatric Fingertip Amputations: a Prospective Observational Study on Pain Progression and Clinical Outcomes

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Pain Progression

研究概览

简要总结

The aim of this prospective cohort study is to assess the outcome and pain progression of fingertip (partial) amputations treated with a semi-occlusive wound dressing (regular care) in childhood and adolescence.The main questions it aims to answer are:

  • What is the pain progression of children and adolescents with fingertip amputations treated with semi-occlusive wound dressing?
  • What is the outcome of children and adolescents with fingertip amputations treated with semi-occlusive wound dressing?

详细描述

The semi-occlusive wound dressing has now become an established method for treating fingertip (partial) amputations. Very good outcomes have been published for adults. A retrospective study also reports very good results in children (Schultz et al., 2018). However, prospective studies describing the outcomes and pain progression of semi-occlusive wound dressings for fingertip (partial) amputations in children and adolescents are not available.

All children and adolescents treated at our clinic for fingertip (partial) amputations using semi-occlusive wound therapy will be included in the study-following written informed consent from the patients and/or their parents.

A case report form will be completed for each patient. On the day of the accident, data regarding the injury will be recorded and photographic documentation will be performed. Patients or their parents will be given a pain diary to be completed once daily at home. The first follow-up examination will take place after two days, with additional visits scheduled weekly up to and including five weeks after the injury (these visits are part of routine care and would occur regardless of the study).

As part of the study-specific follow-ups at six months, range of motion of the affected distal phalanx (compared side-to-side) will be assessed, and any nail growth disturbances will be documented. Photographs of the affected fingertip and the contralateral side will be taken. Patient satisfaction will be recorded on a scale from 0 (dissatisfied) to 100 (very satisfied).

The routine treatment of these injuries at our clinic will not be altered by the study. The only study-related interventions are the daily completion of a pain diary and clinical follow-up examinations at six months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age 0-17 years
  • fingertip amputations Allen I-IV
  • signed informed consent

排除标准

  • no signed informed consent

研究组 & 干预措施

fingertip amputation

children and adolescents with (partial) fingertip amputations (Allen I-IV) treated with semi-occlusive dressings

干预措施: semi-occlusive dressings (Procedure)

结局指标

主要结局

Pain Progression

时间窗: Assessment once daily until end of treatment with semi-occlusive dressings

A pain diary using a visual analogue scale (VAS 0-10); whereas 0 corresponds to no pain and 10 to worst pain

次要结局

  • Length Loss of the finger(once at follow-up at 6 months post-injury)
  • active range of motion(once at follow-up at 6 months post-injury)
  • Percentage of patients with nail growth abnormalities(once at follow-up at 6 months post-injury)
  • Satisfaction with the cosmetic results(once at follow-up at 6 months post-injury)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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