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Evaluation of Oxygen Diffusion Dressing for Accelerating Healing of Donor Site and Other Wounds

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT01268189
First received: December 21, 2010
Last updated: September 8, 2015
Last verified: September 2015
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Burns
Interventions: Device: Oxygen diffusing dressing
Device: Standard of care dressing

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Burn Wound Patients Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites

Participant Flow:   Overall Study
    Burn Wound Patients  
STARTED     20  
COMPLETED     17  
NOT COMPLETED     3  



  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.
Subjects serve as their own control as experimental and standard of care dressings applied to 2 different donor sites. Total of 17 participants completed, with 34 donor sites.

Reporting Groups
  Description
Burn Wound Patients Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft

Baseline Measures
    Burn Wound Patients  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Mean (Full Range)
  35  
  (20 to 49)  
Gender  
[units: participants]
 
Female     3  
Male     14  
Burn Size  
[units: percentage of total skin area]
Mean (Full Range)
  9.2  
  (2 to 24)  



  Outcome Measures
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1.  Primary:   Healing Time for Donor Site Wounds   [ Time Frame: number of days to healing ]

2.  Secondary:   Pain Perceived by Patient   [ Time Frame: Post-Operative Day 4 ]

3.  Secondary:   Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site   [ Time Frame: Post-Operative Day 8 ]

4.  Secondary:   Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site   [ Time Frame: Post-Operative Day 10 ]

5.  Secondary:   Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site   [ Time Frame: Post-Operative Day 12 ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leopoldo C. Cancio, COL, MC
Organization: USAISR
phone: 210-916-3301
e-mail: leopoldo.c.cancio.mil@mail.mil



Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT01268189     History of Changes
Other Study ID Numbers: H-09-008
Study First Received: December 21, 2010
Results First Received: December 10, 2013
Last Updated: September 8, 2015
Health Authority: United States: Federal Government