Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
Primary Purpose
Ankle Fractures, Foot Fracture, Ankle Sprains
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Waterproof padding
Non-waterproof padding
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Fractures
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
- Patients with wounds to the foot or ankle prior to cast placement
- Patients with cognitive dysfunction
Sites / Locations
- West Virginia University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Waterproof padding
Non-waterproof padding
Arm Description
Waterproof, short leg walking cast for 3-7 weeks
Non-waterproof, short leg walking cast for 3-7 weeks
Outcomes
Primary Outcome Measures
Preference for Same Type of Cast (waterproof short leg walking cast)
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)
Proportion of patients who, after treatment, express a preference for the same type of cast.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961957
Brief Title
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
Official Title
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts: a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures, Foot Fracture, Ankle Sprains, Foot Sprain, Toe-walking, Tendonitis of Foot, Apophysitis; Juvenile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This prospective, randomized controlled trial involves the subject being randomized (similar to flipping a coin) by envelope to receive either waterproof padding or non-waterproof padding in their short leg walking cast. The study will take approximately three to seven weeks for the subject to complete (pending date of cast removal).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Waterproof padding
Arm Type
Active Comparator
Arm Description
Waterproof, short leg walking cast for 3-7 weeks
Arm Title
Non-waterproof padding
Arm Type
Active Comparator
Arm Description
Non-waterproof, short leg walking cast for 3-7 weeks
Intervention Type
Device
Intervention Name(s)
Waterproof padding
Intervention Description
Apply waterproof padding to allow for normal bathing and water activities
Intervention Type
Device
Intervention Name(s)
Non-waterproof padding
Intervention Description
Apply standard padding that does not allow for normal bathing and water activities
Primary Outcome Measure Information:
Title
Preference for Same Type of Cast (waterproof short leg walking cast)
Description
Proportion of patients who, after treatment, express a preference for the same type of cast.
Time Frame
Upon Cast Removal (3-7 weeks from cast application)
Title
Preference for Same Type of Cast (non-waterproof short leg walking cast)
Description
Proportion of patients who, after treatment, express a preference for the same type of cast.
Time Frame
Upon Cast Removal (3-7 weeks from cast application)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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
Exclusion Criteria:
Patients with wounds to the foot or ankle prior to cast placement
Patients with cognitive dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Tager, MD
Phone
(304) 293-1165
Email
david.tager@hsc.wvu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tager, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Tager
Phone
304-293-1165
Email
david.tager@hsc.wvu.edu
12. IPD Sharing Statement
Learn more about this trial
Waterproof Casting Versus Standard Casting for Short Leg Walking Casts
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