Polyurethane Foam on the Heel for Prevention in Children

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.

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Key information

Conditions

Flat Foot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Talipes

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyurethane foam dress

Device

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

Primary outcomes

Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)

Time frame: 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 outcomes

Pain (Score on the "Numeric Rating Scale")

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: SCHIUMABIMB

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 1, 2017
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed