Effectiveness of Cotton vs. Waterproof Cast Padding
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|ClinicalTrials.gov Identifier: NCT03859232|
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Developmental Dysplasia of the Hip||Other: Delta Dry® Waterproof Pantaloon Other: Cotton Padding||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Cotton vs. Waterproof Cast Padding After Application of Hip Spica: A Randomized Controlled Study|
|Actual Study Start Date :||March 29, 2018|
|Estimated Primary Completion Date :||March 28, 2022|
|Estimated Study Completion Date :||December 28, 2022|
|Experimental: Delta Dry® Pantaloon Group||
Other: Delta Dry® Waterproof Pantaloon
Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.
|Active Comparator: Cotton Padding Group||
Other: Cotton Padding
Cast with traditional cotton liner.
- Effectiveness as a measure of change in ratings at different time points [ Time Frame: Baseline, 2, 6 and 12 weeks post-application ]
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.
- Quality [ Time Frame: Baseline, 2, 6 and 12 weeks post-application ]
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):
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859232
|Contact: Scott Rosenfeld, MDemail@example.com|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Scott Rosenfeld 832-822-3100 firstname.lastname@example.org|