Effectiveness of Cotton vs. Waterproof Cast Padding

Developmental Dysplasia of the Hip Clinical Trial

Official title:

Effectiveness of Cotton vs. Waterproof Cast Padding After Application of Hip Spica: A Randomized Controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03859232
• Other study ID #: H-41712
• Status: Withdrawn
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: December 28, 2022

Study information

• Verified date: May 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation, Congenital

Intervention

Other:
• Delta Dry® Waterproof Pantaloon
Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.
• Cotton Padding
Cast with traditional cotton liner.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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