Cast Sores With Waterproof Vs. Standard Cast Padding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gortex (Waterproof) Cast Padding

Randomized application of one of two cast padding materials

Group Type ACTIVE_COMPARATOR

Casting using Gortex (waterproof) cast padding materials

Intervention Type OTHER

Cotton/Cotton-Poly Cast Padding

Randomized application of one of two cast padding materials

Group Type ACTIVE_COMPARATOR

Casting using cotton/cotton-poly cast padding materials

Intervention Type OTHER

Interventions

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Casting using Gortex (waterproof) cast padding materials

Intervention Type OTHER

Casting using cotton/cotton-poly cast padding materials

Intervention Type OTHER

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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No