Split Thickness Donor Site Healing With MIST Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celleration, Inc.
ClinicalTrials.gov Identifier:
NCT01214980
First received: October 4, 2010
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Burns
Trauma
Venous Ulcers
Interventions: Device: MIST Therapy
Other: Standard of care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
MIST Therapy in Conjunction With Standard Care

Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment

MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.

Control Arm

Standard of care treatment

Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma


Participant Flow:   Overall Study
    MIST Therapy in Conjunction With Standard Care     Control Arm  
STARTED     16     16  
COMPLETED     13     14  
NOT COMPLETED     3     2  



  Baseline Characteristics
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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.
All enrolled subjects

Reporting Groups
  Description
MIST Therapy in Conjunction With Standard Care

Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment

MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days.

Control Arm

Standard of care treatment

Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma

Total Total of all reporting groups

Baseline Measures
    MIST Therapy in Conjunction With Standard Care     Control Arm     Total  
Number of Participants  
[units: participants]
  16     16     32  
Age  
[units: years]
Median (Full Range)
  32   (20 to 91)     54   (25 to 82)     49   (20 to 91)  
Gender  
[units: participants]
     
Female     5     5     10  
Male     11     11     22  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     12     12     24  
Hispanic/Latino     0     1     1  
African American     4     3     7  
Region of Enrollment  
[units: participants]
     
United States     16     16     32  
BMI  
[units: kilograms per meter squared]
Median (Full Range)
  24.7   (16.8 to 41.1)     25.0   (20.3 to 34.0)     24.7   (16.8 to 41.4)  
Number of donor sites  
[units: number of sites]
Median (Full Range)
  2   (1 to 4)     1.5   (1 to 5)     2   (1 to 5)  
Baseline donor site size  
[units: centimeters squared]
Median (Full Range)
  139.5   (36.0 to 200.0)     136.0   (36.0 to 216.0)     136.0   (36.0 to 216.0)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Wound Healing   [ Time Frame: Days to absence of drainage from the initial donor site harvest procedure ]

2.  Secondary:   Time to Full Epithelialization   [ Time Frame: Days to full epithelialization ]

3.  Secondary:   Numeric Pain Score   [ Time Frame: 5 weeks ]

4.  Secondary:   Numeric Itching Score   [ Time Frame: 5 weeks ]

5.  Secondary:   Donor Site Recidivism Rate   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Participants were not blinded to study treatment.


  More Information
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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: Dr. Lisa Gould
Organization: University South Florida
phone: (410) 736-4646
e-mail: lgould44@hotmail.com


No publications provided


Responsible Party: Celleration, Inc.
ClinicalTrials.gov Identifier: NCT01214980     History of Changes
Other Study ID Numbers: CR-86003
Study First Received: October 4, 2010
Results First Received: December 11, 2014
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board