Effectiveness of Cotton vs. Waterproof Cast Padding

Not Applicable

Withdrawn

• Conditions: Developmental Dysplasia of the Hip
• Interventions: Other: Delta Dry® Waterproof Pantaloon; Other: Cotton Padding

• Registration Number: NCT03859232
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-29
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Primary Completion: 2022-03-28
• Study Completion: 2022-12-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delta Dry® Pantaloon Group	Delta Dry® Waterproof Pantaloon	-
Cotton Padding Group	Cotton Padding	-

Primary Outcome Measures

Name	Time	Method
Effectiveness as a measure of change in ratings at different time points	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

Name	Time	Method
Quality	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

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States