Cotton Sock in Pediatric Patients With Leg-foot Splint | NCT03040882

Studies
Cotton Sock in Pediatric Patients With Leg-foot Splint

NCT03040882

Sponsor

Istituto Ortopedico Rizzoli

Status

Completed

Last Update Posted

Aug 9, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Flat Foot

Interventions

cotton sock
Elastic Compression Wraps

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Jan 30, 2017Actual

Completion Date

Jan 30, 2017Actual

First Submitted Date

Feb 1, 2017

First Submission Date that Met QC Criteria

Feb 1, 2017

First Posted Date

Feb 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2018

Last Update Posted Date

Aug 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cotton sock	Experimental		Other: cotton sock
Elastic Compression Wraps	Active Comparator		Other: Elastic Compression Wraps

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cotton sock	Other	Application of a cotton sock in the immediate postoperative period before applied the Walker	cotton sock

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain	Pain Score on the "Numeric Rating Scale"	up to the first 3 days post intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Caterina Guerra, RN	Istituto Ortopedico Rizzoli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Ortopedico Rizzoli		Bologna		40136	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005413	Flatfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D058128	Compression Bandages

Ancestor Terms

ID	Term
D001458	Bandages
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided