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Cast Sores With Waterproof Vs. Standard Cast Padding

Primary Purpose

Pressure Ulcer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Casting using Gortex (waterproof) cast padding materials

Casting using cotton/cotton-poly cast padding materials

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring Pressure ulcer, Waterproof, Gortex, Cast padding, Pediatric, Heel

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Shriners Hospitals for Children - Honolulu

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Gortex (Waterproof) Cast Padding

Cotton/Cotton-Poly Cast Padding

Arm Description

Randomized application of one of two cast padding materials

Outcomes

Primary Outcome Measures

Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations

Secondary Outcome Measures

Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.

Full Information

NCT ID

NCT00504855

First Posted

July 19, 2007

Last Updated

April 5, 2013

Sponsor

Shriners Hospitals for Children

1. Study Identification

Unique Protocol Identification Number

NCT00504855

Brief Title

Cast Sores With Waterproof Vs. Standard Cast Padding

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

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.

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gortex (Waterproof) Cast Padding

Arm Type

Active Comparator

Arm Description

Randomized application of one of two cast padding materials

Arm Title

Cotton/Cotton-Poly Cast Padding

Arm Type

Active Comparator

Arm Description

Randomized application of one of two cast padding materials

Intervention Type

Other

Intervention Name(s)

Casting using Gortex (waterproof) cast padding materials

Intervention Type

Other

Intervention Name(s)

Casting using cotton/cotton-poly cast padding materials

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.

Time Frame

Cast application to final cast removal

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan B Pellett, MD

Organizational Affiliation

Shriners Hospitals for Children, Honolulu

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arabella I Leet, MD

Organizational Affiliation

Shriners Hospitals for Children, Honolulu

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shriners Hospitals for Children - Honolulu

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96826

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

6723248

Citation

Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available.

Results Reference

background

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Cast Sores With Waterproof Vs. Standard Cast Padding

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