Waterproof Casting Versus Standard Casting for Short Leg Walking Casts

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	5 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04961957
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	West Virginia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Tager, MD
Principal Investigator Affiliation	West Virginia University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ankle Fractures, Foot Fracture, Ankle Sprains, Foot Sprain, Toe-walking, Tendonitis of Foot, Apophysitis; Juvenile

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Waterproof padding

Waterproof, short leg walking cast for 3-7 weeks

Active Comparator: Non-waterproof padding

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

Interventions

Device: - Waterproof padding

Apply waterproof padding to allow for normal bathing and water activities

Device: - Non-waterproof padding

Apply standard padding that does not allow for normal bathing and water activities

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

West Virginia University, Morgantown, West Virginia

Status

Address

West Virginia University

Morgantown, West Virginia, 26506

Site Contact

David Tager

[email protected]

304-293-1165

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