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Cast Sores With Waterproof Vs. Standard Cast Padding

S

Shriners Hospitals for Children

Status

Terminated

Conditions

Pressure Ulcer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00504855
SHCH-JPB-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Gortex (Waterproof) Cast Padding
Active Comparator group
Description:
Randomized application of one of two cast padding materials
Treatment:
Other: Casting using Gortex (waterproof) cast padding materials
Cotton/Cotton-Poly Cast Padding
Active Comparator group
Description:
Randomized application of one of two cast padding materials
Treatment:
Other: Casting using cotton/cotton-poly cast padding materials

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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