Cast Sores With Waterproof Vs. Standard Cast Padding - Full Text View

Sponsored by:	Shriners Hospitals for Children
Information provided by:	Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00504855

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: Gortex cast padding Other: Cotton/cotton-poly cast padding

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	190
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009

Arms	Assigned Interventions
A: Active Comparator Waterproof (Gortex)cast padding	Other: Gortex cast padding Cast padding
B: Active Comparator Cotton/cotton-poly cast padding	Other: Cotton/cotton-poly cast padding Cast padding

Detailed Description:

Cast sores result in pain, scarring and sometines 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

Contacts

Contact: Jonathan B Pellett, MD	808-951-3711	jpellett@shrinenet.org
Contact: Ramona R Fillman, MHA, BSPT	808-951-3693	rfillman@shrinenet.org

Locations

United States, Hawaii
Shriners Hospitals for Children - Honolulu	Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Ramona R Fillman, MHA, BSPT 808-951-3693 rfillman@shrinenet.org
Contact: Jonathan B Pellett, MD 808-951-3711 jpellett@shrinenet.org
Principal Investigator: Jonathan B Pellett, MD
Sub-Investigator: Craig M Ono, MD
Sub-Investigator: Ellen M Raney, MD

Sponsors and Collaborators

Shriners Hospitals for Children

Investigators

Principal Investigator:

Jonathan B Pellett, MD

Shriners Hospitals for Children - Honolulu

More Information

Publications:

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

Study ID Numbers:	SHCH-JPB-1
Study First Received:	July 19, 2007
Last Updated:	July 19, 2007
ClinicalTrials.gov Identifier:	NCT00504855 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:

Pressure ulcer
Waterproof
Gortex

Cast padding
Pediatric
Heel

Study placed in the following topic categories:

Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:

Skin Diseases
Skin Ulcer
Pressure Ulcer

ClinicalTrials.gov processed this record on September 11, 2009