Effectiveness of Cotton vs. Waterproof Cast Padding

Baylor College of Medicine

Status: Withdrawn

Conditions: Developmental Dysplasia of the Hip

Treatments: Other: Delta Dry® Waterproof Pantaloon; Other: Cotton Padding

Study type: Interventional

Funder types: Other

Identifiers

NCT03859232

H-41712

Details and patient eligibility

About

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.

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Delta Dry® Pantaloon Group

Experimental group

Treatment:

Other: Delta Dry® Waterproof Pantaloon

Cotton Padding Group

Active Comparator group

Treatment:

Other: Cotton Padding