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Cast Sores With Waterproof Vs. Standard Cast Padding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00504855
Recruitment Status : 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.)
First Posted : July 20, 2007
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
Jonathan B. Pellett, 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.

Condition or disease Intervention/treatment
Pressure Ulcer Other: Casting using Gortex (waterproof) 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cast Sores With Waterproof Vs. Standard Cast Padding in a Pediatric Population
Study Start Date : July 2007
Primary Completion Date : February 2012
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification. [ Time Frame: Cast application to final cast removal ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Jonathan B. Pellett, Shriners Hospitals for Children:
Pressure ulcer
Waterproof
Gortex
Cast padding
Pediatric
Heel

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action