Cast Sores With Waterproof Vs. Standard Cast Padding

April 5, 2013 updated by: Jonathan B. Pellett, Shriners Hospitals for Children

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Shriners Hospitals for Children - Honolulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time of cast application to final cast removal

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCH-JPB-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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