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

Primary Purpose

Flat Foot, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
polyurethane foam dress
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Flat Foot

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Polyurethane foam

    standard care

    Arm Description

    Only application of the Walker in the immediate postoperative period.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 31, 2017
    Last Updated
    January 22, 2020
    Sponsor
    Istituto Ortopedico Rizzoli
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03039179
    Brief Title
    Polyurethane Foam on the Heel for Prevention in Children
    Acronym
    SCHIUMABIMB
    Official Title
    Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    July 31, 2015 (Actual)
    Study Completion Date
    August 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Istituto Ortopedico Rizzoli

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flat Foot, Pressure Ulcer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Polyurethane foam
    Arm Type
    Experimental
    Arm Title
    standard care
    Arm Type
    No Intervention
    Arm Description
    Only application of the Walker in the immediate postoperative period.
    Intervention Type
    Device
    Intervention Name(s)
    polyurethane foam dress
    Intervention Description
    Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
    Primary Outcome Measure Information:
    Title
    Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
    Description
    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.
    Time Frame
    every day until discharge (expected average of 3 days)
    Secondary Outcome Measure Information:
    Title
    Pain (Score on the "Numeric Rating Scale")
    Description
    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.
    Time Frame
    up to the first 3 days post intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caterina Guerra, RN
    Organizational Affiliation
    Istituto Ortopedico Rizzoli
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Polyurethane Foam on the Heel for Prevention in Children

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