Cast Sores With Waterproof Vs. Standard Cast Padding

Study Overview
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Brief Summary
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The purpose of this study is to compare waterproof cast padding material to standard cotton/poly-cotton cast padding material to the presence or absence of cast sores of the heel.

Detailed Description
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Cast sores result in pain, scarring and sometimes disfigurement. No study has specifically evaluated the efficacy of waterproof cast padding with respect to preventing lower extremity cast sores. Comparison: Non-blinded randomization to waterproof or cotton/cotton-poly cast padding material in a pediatric population who have lower extremity casts that include the foot and are applied in the operating room. Comparison of cast sore incidence will be made in the two randomized groups.

Official Title
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Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Other: Casting using Gortex (waterproof) cast padding materials
* Other: Casting using cotton/cotton-poly cast padding materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at Shriners Hospital for Children - Honolulu Ages 0-18 Short leg, long leg, spica or Petrie cast that includes the foot Cast applied in the operating room Exclusion Criteria: Ponsetti casts (club foot casts with no more surgery than Achilles tenotomy, age < 1 year) Splints cylinder casts or spicas which don't include the foot

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gortex (Waterproof) Cast Padding<br>Randomized application of one of two cast padding materials | Other: Casting using Gortex (waterproof) cast padding materials<br> <br> |
| Active Comparator: Cotton/Cotton-Poly Cast Padding<br>Randomized application of one of two cast padding materials | Other: Casting using cotton/cotton-poly cast padding materials<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations |  | Time of cast application to final cast removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification. |  | Cast application to final cast removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Waterproof, Gortex, Cast padding, Pediatric, Heel