Effectiveness of Cotton vs. Waterproof Cast Padding

NCT ID: NCT03859232

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2022-12-28

Brief Summary

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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

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Conditions

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Developmental Dysplasia of the Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Delta Dry® Pantaloon Group

Group Type EXPERIMENTAL

Delta Dry® Waterproof Pantaloon

Intervention Type OTHER

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

Cotton Padding Group

Group Type ACTIVE_COMPARATOR

Cotton Padding

Intervention Type OTHER

Cast with traditional cotton liner.

Interventions

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Delta Dry® Waterproof Pantaloon

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

Intervention Type OTHER

Cotton Padding

Cast with traditional cotton liner.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Scott Rosenfeld

Associate Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-41712

Identifier Type: -

Identifier Source: org_study_id

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