Polyurethane Foam on the Heel for Prevention in Children

Istituto Ortopedico Rizzoli80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Flat Foot Pressure Ulcer

Interventions

polyurethane foam dressDEVICE

Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: every day until discharge (expected average of 3 days)

Secondary Outcomes

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.

Time frame: up to the first 3 days post intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.