Polyurethane Foam on the Heel for Prevention in Children

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial

Conditions
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Flat Foot, Pressure Ulcer

Intervention / Treatment
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* Device: polyurethane foam dress


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyurethane foam<br> | Device: polyurethane foam dress<br>* Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker<br>|
| No Intervention: standard care<br>Only application of the Walker in the immediate postoperative period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) | Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss. | every day until discharge (expected average of 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Score on the Numeric Rating Scale) | Pain Score on the Numeric Rating Scale > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain. | up to the first 3 days post intervention |