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临床试验/NCT04961957
NCT04961957撤回不适用

Waterproof Casting Versus Standard Casting for Short Leg Walking Casts: a Prospective Randomized Controlled Trial

West Virginia University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9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
撤回
入组人数
100
试验地点
2
主要终点
Preference for Same Type of Cast (waterproof short leg walking cast)

研究概览

简要总结

The purpose of the study is to determine whether the use of waterproof padding in short leg walking casts will lead to an increase in cast-related complications, as compared to the standard non-waterproof casting in children.

详细描述

This study aims to prospectively examine a group of pediatric patients that receive either a waterproof or non-waterproof short leg cast. From this, we will be able to determine if there are any significant differences between the two groups. If waterproof short leg casts do not cause increased skin breakdown or lead to increases in cast complications and unintended clinic visits, then we can more confidently apply them to pediatric patients, particularly in the summer months when children are more likely to swim.

On application of a waterproof, short leg walking cast, a questionnaire will be distributed to the patient/family to track how many times the cast gets wet. During the application of the cast, materials will be tracked for cost analysis. The subject will return between 3 and 7 weeks for cast removal. On cast removal, the following questionnaires will be completed: cast condition, skin condition, overall patient/family satisfaction, and PROMIS Pediatric Lower Extremity Function - Mobility. Questionnaires will take approximately 5 - 10 minutes to complete. The parent survey regarding how many times the cast got wet will be returned (if applicable). Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference.

Outside of the randomization itself, all standard of care procedures or normal practice activities will occur. Each participant will undergo cast application as recommended per standard of care. Study participation does not involve more than minimal risk since everything outside of the randomization is standard of care.

Waterproof and non-waterproof groups will be compared in the basis of cast condition, PROMIS lower extremity survey outcomes, skin condition, overall patient/family satisfaction, number of unintended cast changes or return clinic visits, as well as cost difference. A Chi-Square test will be used to analyze the data.

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
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Being placed in a short leg walking cast for one of the diagnoses listed below:
  • •ankle fracture
  • •foot fracture
  • •ankle sprain
  • •foot sprain
  • •toe-walking
  • •tendonitis
  • •apophysitis

排除标准

  • •Patients with wounds to the foot or ankle prior to cast placement
  • •Patients with cognitive dysfunction

研究组 & 干预措施

Non-waterproof padding

Active Comparator

Non-waterproof, short leg walking cast for 3-7 weeks

干预措施: Non-waterproof padding (Device)

Waterproof padding

Active Comparator

Waterproof, short leg walking cast for 3-7 weeks

干预措施: Waterproof padding (Device)

结局指标

主要结局

Preference for Same Type of Cast (waterproof short leg walking cast)

时间窗: Upon Cast Removal (3-7 weeks from cast application)

Proportion of patients who, after treatment, express a preference for the same type of cast.

Preference for Same Type of Cast (non-waterproof short leg walking cast)

时间窗: Upon Cast Removal (3-7 weeks from cast application)

Proportion of patients who, after treatment, express a preference for the same type of cast.

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

David Tager

Assistant Professor

West Virginia University

研究点 (2)

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