- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03040882
Cotton Sock in Pediatric Patients With Leg-foot Splint
August 8, 2018 updated by: Istituto Ortopedico Rizzoli
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cotton sock
|
Application of a cotton sock in the immediate postoperative period before applied the Walker
|
Active Comparator: Elastic Compression Wraps
|
Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
every day until discharge (expected average of 3 days).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: up to the first 3 days post intervention
|
Pain Score on the "Numeric Rating Scale"
|
up to the first 3 days post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caterina Guerra, RN, Istituto Ortopedico Rizzoli
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
January 30, 2017
Study Completion (Actual)
January 30, 2017
Study Registration Dates
First Submitted
February 1, 2017
First Submitted That Met QC Criteria
February 1, 2017
First Posted (Estimate)
February 2, 2017
Study Record Updates
Last Update Posted (Actual)
August 9, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0014868
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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