Polyurethane Foam on the Heel for Prevention in Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-01

Study Completion Date

2015-08-31

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.

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Detailed Description

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Conditions

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Flat Foot Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Polyurethane foam

Group Type EXPERIMENTAL

polyurethane foam dress

Intervention Type DEVICE

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

standard care

Only application of the Walker in the immediate postoperative period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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polyurethane foam dress

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

Intervention Type DEVICE

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No