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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
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Flat Foot
Pressure Ulcer
Intervention Device: polyurethane foam dress
Enrollment 80
Recruitment Details The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.
Pre-assignment Details  
Arm/Group Title Polyurethane Foam Standard Care
Hide Arm/Group Description polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker Only application of the Walker in the immediate postoperative period.
Period Title: Overall Study
Started 38 42
Completed 38 42
Not Completed 0 0
Arm/Group Title Polyurethane Foam Standard Care Total
Hide Arm/Group Description polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 38 42 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 42 participants 80 participants
11.79  (1.27) 11.64  (1.44) 11.71  (1.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
Female
15
  39.5%
16
  38.1%
31
  38.8%
Male
23
  60.5%
26
  61.9%
49
  61.3%
type of surgery:Calcaneal Osteotomy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
37
  97.4%
39
  92.9%
76
  95.0%
type of analgesia:peripheral nerve blocks analgesia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
10
  26.3%
13
  31.0%
23
  28.7%
1.Primary Outcome
Title Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyurethane Foam Standard Care
Hide Arm/Group Description:
polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
[Not Specified]
Overall Number of Participants Analyzed 38 42
Measure Type: Count of Participants
Unit of Measure: Participants
17
  44.7%
21
  50.0%
2.Secondary Outcome
Title Pain (Score on the "Numeric Rating Scale")
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polyurethane Foam Standard Care
Hide Arm/Group Description:
polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
[Not Specified]
Overall Number of Participants Analyzed 38 42
Measure Type: Count of Participants
Unit of Measure: Participants
26
  68.4%
25
  59.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyurethane Foam Standard Care
Hide Arm/Group Description polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker [Not Specified]
All-Cause Mortality
Polyurethane Foam Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/42 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Polyurethane Foam Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polyurethane Foam Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Head of the Research Nursing Unit
Organization: Istituto Ortopedico Rizzoli
Phone: 0516366694 ext 0039
Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03039179     History of Changes
Other Study ID Numbers: 0024520
First Submitted: January 31, 2017
First Posted: February 1, 2017
Results First Submitted: February 1, 2017
Results First Posted: March 22, 2017
Last Update Posted: May 18, 2017