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Cotton Sock in Pediatric Patients With Leg-foot Splint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03040882
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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.

Condition or disease Intervention/treatment Phase
Flat Foot Other: cotton sock Other: Elastic Compression Wraps Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : July 1, 2016
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: cotton sock Other: cotton sock
Application of a cotton sock in the immediate postoperative period before applied the Walker

Active Comparator: Elastic Compression Wraps 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)

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain [ Time Frame: up to the first 3 days post intervention ]
    Pain Score on the "Numeric Rating Scale"

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03040882

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Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
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Principal Investigator: Caterina Guerra, RN Istituto Ortopedico Rizzoli
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Responsible Party: Istituto Ortopedico Rizzoli Identifier: NCT03040882    
Other Study ID Numbers: 0014868
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities