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

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ClinicalTrials.gov Identifier: NCT01268189
Recruitment Status : Completed
First Posted : December 29, 2010
Results First Posted : October 9, 2015
Last Update Posted : October 9, 2015
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Burns
Interventions Device: Oxygen diffusing dressing
Device: Standard of care dressing
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Burn Wound Patients
Hide Arm/Group Description Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
Period Title: Overall Study
Started 20
Completed 17
Not Completed 3
Arm/Group Title Burn Wound Patients
Hide Arm/Group Description 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
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
35
(20 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
3
  17.6%
Male
14
  82.4%
Burn Size  
Mean (Full Range)
Unit of measure:  Percentage of total skin area
Number Analyzed 17 participants
9.2
(2 to 24)
1.Primary Outcome
Title Healing Time for Donor Site Wounds
Hide Description Wounds are inspected on postoperative days 4, 8, and then every two days until the wound is deemed to be healed.
Time Frame number of days to healing
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description:

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: days
9.4  (1.7) 12.4  (2.7)
2.Secondary Outcome
Title Pain Perceived by Patient
Hide Description Patient will be asked to rate pain 0-10 (0=no pain, 10=maximum pain) at the study site and the control site. Used Visual Analogue Scale (VAS) for this purpose.
Time Frame Post-Operative Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description:

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.6  (1.6) 1.6  (1.9)
3.Secondary Outcome
Title Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Hide Description [Not Specified]
Time Frame Post-Operative Day 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description:

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (1.3) 1.4  (2.2)
4.Secondary Outcome
Title Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Hide Description [Not Specified]
Time Frame Post-Operative Day 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description:

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.3  (1) 0.8  (1.5)
5.Secondary Outcome
Title Patient Will be Asked to Rate Pain 0-10/10 at the Study Site and the Control Site
Hide Description [Not Specified]
Time Frame Post-Operative Day 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description:

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (0.8) 0.5  (1.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Dressing Control Dressing
Hide Arm/Group Description

Oxygen diffusing dressing applied to wound

Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound

Xeroform (current standard of care) dressing applied to wound

Control dressing: Xeroform control dressing applied to control wound

All-Cause Mortality
Study Dressing Control Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Dressing Control Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Dressing Control Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      2/17 (11.76%)    
Skin and subcutaneous tissue disorders     
Blistering   2/17 (11.76%)  2 2/17 (11.76%)  2
Indicates events were collected by systematic assessment
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
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT01268189     History of Changes
Other Study ID Numbers: H-09-008
First Submitted: December 21, 2010
First Posted: December 29, 2010
Results First Submitted: December 10, 2013
Results First Posted: October 9, 2015
Last Update Posted: October 9, 2015