Polyurethane Foam on the Heel for Prevention in Children (SCHIUMABIMB)

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Pressure Ulcer; Flat Foot

Treatments: Device: polyurethane foam dress

Study type: Interventional

Funder types: Other

Identifiers

NCT03039179

0024520

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 aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.

Enrollment: 80 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged > 3 years underwent surgery 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 after surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Polyurethane foam

Experimental group

Treatment:

Device: polyurethane foam dress

standard care

No Intervention group

Description:

Only application of the Walker in the immediate postoperative period.