Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ankle Fractures; Ankle Sprains; Apophysitis; Juvenile; Foot Fracture; Foot Sprain; Toe-walking; Tendonitis of Foot
• Intervention / Treatment: Device: Waterproof padding; Device: Non-waterproof padding

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Tager, MD; Phone Number: (304) 293-1165; Email: david.tager@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
      • Contact: David Tager; Phone Number: 304-293-1165; Email: david.tager@hsc.wvu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Waterproof padding; Waterproof, short leg walking cast for 3-7 weeks	Device: Waterproof padding; Apply waterproof padding to allow for normal bathing and water activities
Active Comparator: Non-waterproof padding; Non-waterproof, short leg walking cast for 3-7 weeks	Device: Non-waterproof padding; Apply standard padding that does not allow for normal bathing and water activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: David Tager, MD, West Virginia University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Fractures, Bone; Sprains and Strains; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: 2102248177

Drug and device information, study documents

• 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