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Cast Sores With Waterproof Vs. Standard Cast Padding

This study has been terminated.
(Staffing changes resulted in the expiration of IRB approval (2/15/12), and recruitment halted (n=84). IRB approval is now current for retrospective analysis.)
Sponsor:
Information provided by (Responsible Party):
Jonathan B. Pellett, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00504855
First received: July 19, 2007
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Pressure Ulcer
 Other: Casting using Gortex (waterproof) cast padding materials
Other: Casting using cotton/cotton-poly cast padding materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations [ Time Frame: Time of cast application to final cast removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification. [ Time Frame: Cast application to final cast removal ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: July 2007
Estimated Study Completion Date: March 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gortex (Waterproof) Cast Padding
Randomized application of one of two cast padding materials
 Other: Casting using Gortex (waterproof) cast padding materials
Active Comparator: Cotton/Cotton-Poly Cast Padding
Randomized application of one of two cast padding materials
 Other: Casting using cotton/cotton-poly cast padding materials

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00504855

Locations
United States, Hawaii
Shriners Hospitals for Children - Honolulu
Honolulu, Hawaii, United States, 96826
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Jonathan B Pellett, MD Shriners Hospitals for Children - Honolulu
Principal Investigator: Arabella I Leet, MD Shriners Hospitals for Children - Honolulu
  More Information

Publications:

Responsible Party: Jonathan B. Pellett, Staff Orthopaedic Surgeon, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00504855     History of Changes
Other Study ID Numbers: SHCH-JPB-1
Study First Received: July 19, 2007
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Pressure ulcer
Waterproof
Gortex
 Cast padding
Pediatric
Heel

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013