Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04961957
• Other study ID #: 2102248177
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: West Virginia University
• Contact: David Tager, MD
• Phone: (304) 293-1165
• Email: david.tager[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures
• Ankle Injuries
• Ankle Sprains
• Apophysitis; Juvenile
• Foot Fracture
• Fractures, Bone
• Sprains and Strains
• Tendinopathy

Intervention

Device:
• Waterproof padding
Apply waterproof padding to allow for normal bathing and water activities
• Non-waterproof padding
Apply standard padding that does not allow for normal bathing and water activities

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Upon Cast Removal (3-7 weeks from cast application)
Primary	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.	Upon Cast Removal (3-7 weeks from cast application)