Back to resultsCotton Sock in Pediatric Patients With Leg-foot Splint
Primary Purpose
Flat Foot
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
cotton sock
Elastic Compression Wraps
Sponsored by
About this trial
This is an interventional prevention trial for Flat Foot
Eligibility Criteria
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
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cotton sock
Elastic Compression Wraps
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain
Pain Score on the "Numeric Rating Scale"
Full Information
NCT ID
NCT03040882
First Posted
February 1, 2017
Last Updated
August 8, 2018
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT03040882
Brief Title
Cotton Sock in Pediatric Patients With Leg-foot Splint
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Foot
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cotton sock
Arm Type
Experimental
Arm Title
Elastic Compression Wraps
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
cotton sock
Intervention Description
Application of a cotton sock in the immediate postoperative period before applied the Walker
Intervention Type
Other
Intervention Name(s)
Elastic Compression Wraps
Intervention Description
Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
Primary Outcome Measure Information:
Title
Heel Pressure Sores
Description
• 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.
Time Frame
every day until discharge (expected average of 3 days).
Secondary Outcome Measure Information:
Title
Pain
Description
Pain Score on the "Numeric Rating Scale"
Time Frame
up to the first 3 days post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Guerra, RN
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cotton Sock in Pediatric Patients With Leg-foot Splint
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