Cast Sores With Waterproof Vs. Standard Cast Padding

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00504855
• Other study ID #: SHCH-JPB-1
• Status: Terminated
• Phase: N/A
• First received: July 19, 2007
• Last updated: April 5, 2013
• Start date: July 2007
• Est. completion date: March 2014

Study information

• Verified date: April 2013
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: March 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

Other:
• Casting using Gortex (waterproof) cast padding materials

• Casting using cotton/cotton-poly cast padding materials

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children - Honolulu	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of cast sores, including size, location, grade using Wagner's Classification system for the severe diabetic foot ulcerations		Time of cast application to final cast removal	No
Secondary	Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification.		Cast application to final cast removal	No