Polyurethane Foam on the Heel for Prevention in Children

Not Applicable

Completed

• Conditions: Pressure Ulcer; Flat Foot
• Interventions: Device: polyurethane foam dress

• Registration Number: NCT03039179
• Lead Sponsor: Istituto Ortopedico Rizzoli

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 aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2015-07-31
• Study Completion: 2015-08-31
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Results First Submitted: 2017-02-01
• Results First Submitted QC: 2017-02-01
• Results First Posted: 2017-03-22
• Status Verified: 2017-04
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children aged > 3 years underwent surgery 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 after surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyurethane foam	polyurethane foam dress	-

Primary Outcome Measures

Name	Time	Method
Heel Pressure Sores (Numbers of Participants With 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.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.

Secondary Outcome Measures

Name	Time	Method
Pain (Score on the "Numeric Rating Scale")	up to the first 3 days post intervention	Pain Score on the "Numeric Rating Scale" \> 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.