Cotton Sock in Pediatric Patients With Leg-foot Splint

Effectiveness of Cotton Sock in Pediatric Patients With Leg-foot Splint After Surgery for Correction of the Foot, in Reducing the Incidence of Cutaneous Lesions. Randomized Controlled Trial.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03040882

Enrollment

100

Registered

2017-02-02

Start date

2016-07-01

Completion date

2017-01-30

Last updated

2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flat Foot

Brief summary

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.

Interventions

OTHERcotton sock

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

OTHERElastic Compression Wraps

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Heel Pressure Sores	every day until discharge (expected average of 3 days).	• 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.

Secondary

Measure	Time frame	Description
Pain	up to the first 3 days post intervention	Pain Score on the Numeric Rating Scale

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026