Polyurethane Foam on the Heel for Prevention in Children (SCHIUMABIMB)
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|ClinicalTrials.gov Identifier: NCT03039179|
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : March 22, 2017
Last Update Posted : May 18, 2017
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03039179
|Principal Investigator:||Caterina Guerra, RN||Istituto Ortopedico Rizzoli|