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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.
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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Polyurethane Foam polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
Standard Care Only application of the Walker in the immediate postoperative period.

Participant Flow:   Overall Study
    Polyurethane Foam   Standard Care
STARTED   38   42 
COMPLETED   38   42 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Polyurethane Foam polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
Standard Care No text entered.
Total Total of all reporting groups

Baseline Measures
   Polyurethane Foam   Standard Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   42   80 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.79  (1.27)   11.64  (1.44)   11.71  (1.35) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
 37   39   76 
type of analgesia:peripheral nerve blocks analgesia 
[Units: Participants]
Count of Participants
 10   13   23 


  Outcome Measures

1.  Primary:   Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)   [ Time Frame: every day until discharge (expected average of 3 days) ]

2.  Secondary:   Pain (Score on the "Numeric Rating Scale")   [ Time Frame: up to the first 3 days post intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: cristiana.forni@ior.it



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