Aim: The incidence of pressure sore in critically ill patients is high and this can be increased the risk of mortality. So this study designed to evaluation of the effect of topical oxygen therapy on pressure sore healing of traumatic critically ill patients.
Design: A double blind clinical trial study on 80 eligible patients (inclusion criteria: 17-65 Y/O, without underlying medical conditions including organ failure, diabetes and burns. Exclusion criteria: systemic corticosteroid usage, chronic skin disease organ failure) will be done after assigned to two groups.
Intervention: In the intervention group, the wound surface is in contact with moist oxygen at a rate of 10 liters per minute for 20 minutes, every day and then covered with a sterile gauze dressing. In the control group The routine dressing will be done. The intervening period will be 15 days.
Outcomes: The area of pressure ulcer (length, width and depth) with Push scale and the stage of wound by direct observation are determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602275426N9
Registration date:2016-08-12, 1395/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-12, 1395/05/22
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2016-05-17, 1395/02/28
Expected recruitment end date
2016-11-18, 1395/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Topical Oxygen on Wound healing of trauma patients admitted in Intensive Care Units of Kerman University of Medical Sciences
Public title
Effect of Topical Oxygen on healing of Pressure ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 17-65 Y/O; without underlying medical conditions including organ failure, diabetes and burns.
Exclusion criteria: systemic corticosteroid usage; chronic skin disease; organ failure; patient death
Age
From 17 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Postal code
7619813159
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.KMU.REC.1395.18
Health conditions studied
1
Description of health condition studied
Pressure ulcers
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Stage of Pressure ulcer
Timepoint
Every three day
Method of measurement
Direct observation of wound
2
Description
The area of pressure ulcer (length, width and depth)
Timepoint
Every three day
Method of measurement
Push Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the wound surface is in contact with moist oxygen at a rate of 10 liters per minute for 20 minutes, every day and then covered with a sterile gauze dressing.