Back to resultsEffectiveness of Cotton vs. Waterproof Cast Padding
Primary Purpose
Developmental Dysplasia of the Hip
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delta Dry® Waterproof Pantaloon
Cotton Padding
Sponsored by
About this trial
This is an interventional other trial for Developmental Dysplasia of the Hip
Eligibility Criteria
Inclusion Criteria:
- Paediatric patients (<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.
Exclusion Criteria:
- Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon
- Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Delta Dry® Pantaloon Group
Cotton Padding Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03859232
Brief Title
Effectiveness of Cotton vs. Waterproof Cast Padding
Official Title
Effectiveness of Cotton vs. Waterproof Cast Padding After Application of Hip Spica: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Could not enroll participants
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
March 28, 2022 (Anticipated)
Study Completion Date
December 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Dysplasia of the Hip
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delta Dry® Pantaloon Group
Arm Type
Experimental
Arm Title
Cotton Padding Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Delta Dry® Waterproof Pantaloon
Intervention Description
Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.
Intervention Type
Other
Intervention Name(s)
Cotton Padding
Intervention Description
Cast with traditional cotton liner.
Primary Outcome Measure Information:
Title
Effectiveness as a measure of change in ratings at different time points
Description
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.
Time Frame
Baseline, 2, 6 and 12 weeks post-application
Secondary Outcome Measure Information:
Title
Quality
Description
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
Time Frame
Baseline, 2, 6 and 12 weeks post-application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Paediatric patients (<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.
Exclusion Criteria:
Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon
Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effectiveness of Cotton vs. Waterproof Cast Padding
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