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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gortex (Waterproof) Cast Padding | Active Comparator | Randomized application of one of two cast padding materials |
|
| Cotton/Cotton-Poly Cast Padding | Active Comparator | Randomized application of one of two cast padding materials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casting using Gortex (waterproof) cast padding materials | Other |
| ||
| Casting using cotton/cotton-poly cast padding materials |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of: abrasion; pressure/sheer; maceration wetness; infection; cast modification. | Cast application to final cast removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan B Pellett, MD | Shriners Hospitals for Children, Honolulu | Principal Investigator |
| Arabella I Leet, MD | Shriners Hospitals for Children, Honolulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children - Honolulu | Honolulu | Hawaii | 96826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6723248 | Background | Wagner FW Jr. Treatment of the diabetic foot. Compr Ther. 1984 Apr;10(4):29-38. No abstract available. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Other |
|