Effectiveness of Cotton vs. Waterproof Cast Padding

NCT03859232 | Withdrawn

• 1 other identifier: H-41712
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality

  Baseline, 2, 6 and 12 weeks post-application

Study Arms (2)

Delta Dry® Pantaloon Group

EXPERIMENTAL

Other: Delta Dry® Waterproof Pantaloon

Cotton Padding Group

ACTIVE COMPARATOR

Other: Cotton Padding

Interventions

Delta Dry® Waterproof Pantaloon OTHER

Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.

Delta Dry® Pantaloon Group

Cotton Padding OTHER

Cast with traditional cotton liner.

Cotton Padding Group

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: March 1, 2019
• Study Start: March 29, 2018
• Primary Completion: March 28, 2022
• Study Completion: December 28, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

US (1)