Cotton Sock in Pediatric Patients With Leg-foot Splint

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Flat Foot

Treatments: Other: Elastic Compression Wraps; Other: cotton sock

Study type: Interventional

Funder types: Other

Identifiers

NCT03040882

0014868

Details and patient eligibility

About

The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The problems persist also after placing a polyurethane foam dress at the heel in the immediate postoperative period. The aim of this study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous lesions.

Enrollment: 100 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged > 3 years
• Treated for flat foot
• Children with intact skin at the heel

Exclusion criteria

• Caregivers who cannot speak Italian
• Those who refuse to give their consent to take part in the study
• Patients with lower limb casts

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

cotton sock

Experimental group

Treatment:

Other: cotton sock

Elastic Compression Wraps

Active Comparator group

Treatment:

Other: Elastic Compression Wraps