Cotton Sock in Pediatric Patients With Leg-foot Splint

NCT ID: NCT03040882

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-01-30

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 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.

Detailed Description

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Conditions

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Flat Foot

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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cotton sock

Group Type EXPERIMENTAL

cotton sock

Intervention Type OTHER

Application of a cotton sock in the immediate postoperative period before applied the Walker

Elastic Compression Wraps

Group Type ACTIVE_COMPARATOR

Elastic Compression Wraps

Intervention Type OTHER

Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)

Interventions

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cotton sock

Application of a cotton sock in the immediate postoperative period before applied the Walker

Intervention Type OTHER

Elastic Compression Wraps

Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caterina Guerra, RN

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0014868

Identifier Type: -

Identifier Source: org_study_id

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