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This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delta Dry® Pantaloon Group | Experimental |
| |
| Cotton Padding Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta Dry® Waterproof Pantaloon | Other | Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness as a measure of change in ratings at different time points | The primary outcome (effectiveness) will be measured based on the change in ratings to the following variables/factors using a 10 point likert scale (1 being very poor and 10 being excellent): Comfort, Ability for the cast to dry if it became wet, Cast odor, Cast durability, Protection from skin irritation, Ease of care in the cast, Ease of Application, Padding Aesthetics, Application Time, Skin Condition, Lack of Maceration / Excoriation, Cast Odor, Padding Condition, and Ease of Removal. These will be collected at baseline, 2, 6 and 12 weeks post-application. | Baseline, 2, 6 and 12 weeks post-application |
| Measure | Description | Time Frame |
|---|---|---|
| Quality | The secondary outcome (quality) will be measured based on rating to the following using a 10 point likert scale (1 being very poor and 10 being excellent): Overall Quality | Baseline, 2, 6 and 12 weeks post-application |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D000082602 | Developmental Dysplasia of the Hip |
| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Cotton Padding | Other | Cast with traditional cotton liner. |
|
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |