Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

West Virginia University

Status: Withdrawn

Conditions: Foot Fracture; Toe-walking; Ankle Sprains; Foot Sprain; Tendonitis of Foot; Ankle Fractures; Apophysitis; Juvenile

Treatments: Device: Non-waterproof padding; Device: Waterproof padding

Study type: Interventional

Funder types: Other

Identifiers

NCT04961957

2102248177

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Waterproof padding

Active Comparator group

Description:

Waterproof, short leg walking cast for 3-7 weeks

Treatment:

Device: Waterproof padding

Non-waterproof padding

Active Comparator group

Description:

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

Treatment:

Device: Non-waterproof padding