Cotton Sock in Pediatric Patients With Leg-foot Splint

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 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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 30, 2017

Interventions

  • Other: cotton sock
    • Application of a cotton sock in the immediate postoperative period before applied the Walker
  • 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)

Arms, Groups and Cohorts

  • Experimental: cotton sock
  • Active Comparator: Elastic Compression Wraps

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Pain
    • Time Frame: up to the first 3 days post intervention
    • Pain Score on the “Numeric Rating Scale”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istituto Ortopedico Rizzoli
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Caterina Guerra, RN, Principal Investigator, Istituto Ortopedico Rizzoli

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.