Polyurethane Foam on the Heel for Prevention in Children (SCHIUMABIMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03039179
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : March 22, 2017
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Flat Foot Pressure Ulcer Device: polyurethane foam dress Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : August 31, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: Polyurethane foam Device: polyurethane foam dress
Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

No Intervention: standard care
Only application of the Walker in the immediate postoperative period.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03039179

Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Principal Investigator: Caterina Guerra, RN Istituto Ortopedico Rizzoli

Responsible Party: Istituto Ortopedico Rizzoli Identifier: NCT03039179     History of Changes
Other Study ID Numbers: 0024520
First Posted: February 1, 2017    Key Record Dates
Results First Posted: March 22, 2017
Last Update Posted: May 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Pressure Ulcer
Skin Ulcer
Skin Diseases
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities