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Completed

NCT Number: NCT03040882

Cotton Sock in Pediatric Patients With Leg-foot Splint

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.

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Key information

Conditions

Flat Foot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cotton sock

Other

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

Elastic Compression Wraps

Other

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

Primary outcomes

  1. Heel Pressure Sores

    Time frame: 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 outcomes

  1. Pain

    Time frame: up to the first 3 days post intervention

    Pain Score on the "Numeric Rating Scale"

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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