Effectiveness of Cotton vs. Waterproof Cast Padding

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Developmental Dysplasia of the Hip
• Intervention / Treatment: Other: Delta Dry® Waterproof Pantaloon; Other: Cotton Padding

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Rosenfeld, MD; Phone Number: 832.822.3100; Email: sbrosenf@texaschildrens.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Anticipated): March 28, 2022
• Study Completion (Anticipated): December 28, 2022

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: February 27, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: H-41712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No