Cotton Sock in Pediatric Patients With Leg-foot Splint

Flat Foot Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040882
• Other study ID #: 0014868
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: January 2017
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Flat Foot
• Flatfoot

Intervention

Other:
• cotton sock
Application of a cotton sock in the immediate postoperative period before applied the Walker
• Elastic Compression Wraps
Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heel Pressure Sores	• 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.	every day until discharge (expected average of 3 days).
Secondary	Pain	Pain Score on the "Numeric Rating Scale"	up to the first 3 days post intervention