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Effectiveness of Cotton vs. Waterproof Cast Padding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859232
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Scott Rosenfeld, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Developmental Dysplasia of the Hip Other: Delta Dry® Waterproof Pantaloon Other: Cotton Padding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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):

    Overall Quality




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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Scott Rosenfeld, MD 832.822.3100 sbrosenf@texaschildrens.org

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Scott Rosenfeld    832-822-3100    sbrosenf@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
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Responsible Party: Scott Rosenfeld, Associate Professor of Orthopaedic Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03859232    
Other Study ID Numbers: H-41712
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hip Dislocation, Congenital
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities