Cotton Sock in Pediatric Patients With Leg-foot Splint

• Sponsor: Istituto Ortopedico Rizzoli (Other)
• Overall Status: Completed
• CT.gov ID: NCT03040882
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 14.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Flat Foot	Other: cotton sock; Other: Elastic Compression Wraps	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2016
• Actual Primary Completion Date: Jan 30, 2017
• Actual Study Completion Date: Jan 30, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Heel Pressure Sores [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 [up to the first 3 days post intervention]

   Pain Score on the "Numeric Rating Scale"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Ortopedico Rizzoli	Bologna		Italy	40136

Sponsors and Collaborators

• Istituto Ortopedico Rizzoli

Investigators

• Principal Investigator: Caterina Guerra, RN, Istituto Ortopedico Rizzoli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istituto Ortopedico Rizzoli
• ClinicalTrials.gov Identifier: NCT03040882
• Other Study ID Numbers: 0014868
• First Posted: Feb 2, 2017
• Last Update Posted: Aug 9, 2018
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Flatfoot

Study Results

No Results Posted as of Aug 9, 2018