Cast Sores With Waterproof Vs. Standard Cast Padding

Not Applicable

Terminated

• Conditions: Pressure Ulcer
• Interventions: Other: Casting using Gortex (waterproof) cast padding materials; Other: Casting using cotton/cotton-poly cast padding materials

• Registration Number: NCT00504855
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-19
• Study First Submitted QC: 2007-07-19
• Study First Posted: 2007-07-20
• Primary Completion: 2012-02
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gortex (Waterproof) Cast Padding	Casting using Gortex (waterproof) cast padding materials	Randomized application of one of two cast padding materials
Cotton/Cotton-Poly Cast Padding	Casting using cotton/cotton-poly cast padding materials	Randomized application of one of two cast padding materials

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.	Cast application to final cast removal

Trial Locations

Locations (1)

Shriners Hospitals for Children - Honolulu; 🇺🇸 Honolulu, Hawaii, United States