Cotton Sock in Pediatric Patients With Leg-foot Splint
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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2017
CompletedFirst Submitted
Initial submission to the registry
February 1, 2017
CompletedFirst Posted
Study publicly available on registry
February 2, 2017
CompletedAugust 9, 2018
January 1, 2017
7 months
February 1, 2017
August 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pain
up to the first 3 days post intervention
Study Arms (2)
cotton sock
EXPERIMENTALElastic Compression Wraps
ACTIVE COMPARATORInterventions
Application of a cotton sock in the immediate postoperative period before applied the Walker
Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
Eligibility Criteria
You may qualify if:
- Children aged \> 3 years
- Treated for flat foot
- Children with intact skin at the heel
You may not qualify if:
- Caregivers who cannot speak Italian
- Those who refuse to give their consent to take part in the study
- Patients with lower limb casts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caterina Guerra, RN
Istituto Ortopedico Rizzoli
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2017
First Posted
February 2, 2017
Study Start
July 1, 2016
Primary Completion
January 30, 2017
Study Completion
January 30, 2017
Last Updated
August 9, 2018
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share