Polyurethane Foam on the Heel for Prevention in Children

Pressure Ulcer Clinical Trial

— SCHIUMABIMB  

Official title:

Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039179
• Other study ID #: 0024520
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: August 31, 2015

Study information

• Verified date: April 2017
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Flat Foot
• Flatfoot
• Pressure Ulcer

Intervention

Device:
• polyurethane foam dress
Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heel Pressure Sores (Numbers of Participants With 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.: 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.	every day until discharge (expected average of 3 days)
Secondary	Pain (Score on the "Numeric Rating Scale")	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.	up to the first 3 days post intervention