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Cast Sores With Waterproof Vs. Standard Cast Padding

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00504855
Enrollment
84
Registered
2007-07-20
Start date
2007-07-31
Completion date
2014-03-31
Last updated
2013-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Pressure ulcer, Waterproof, Gortex, Cast padding, Pediatric, Heel

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.

Interventions

OTHERCasting using Gortex (waterproof) cast padding materials
OTHERCasting using cotton/cotton-poly cast padding materials

Sponsors

Shriners Hospitals for Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerationsTime of cast application to final cast removal

Secondary

MeasureTime frame
Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.Cast application to final cast removal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026