The objective of present study was to determine the effects of “Topical High Pressure Oxygen Therapy” on healing of bedsore. Through a randomized single-blinded clinical trial, 100 patients were randomly allocated into 2 equal groups. Inclusion criteria were presence of bedsore, degree 1-4 based on classification of world bedsore category, and exclusion criteria was presence of vascular damage such as "Burger Syndrome". For intervention group in addition to routine wound care, topical high pressure oxygen (10 L/m) with catheter was applied for 20 minutes, 3 times a day but for control group Just routine wound care was done. Primary outcome was size of bedsore, measured before intervention and every 48 hours in both groups for 4 week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138708051407N1
Registration date:2009-04-25, 1388/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-04-25, 1388/02/05
Registrant information
Name
Jalil Azimian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 7267
Email address
jazzimian@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2006-03-11, 1384/12/20
Expected recruitment end date
2008-03-10, 1386/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of topical high pressure oxygen therapy on healing of bedsore
Public title
Topical oxygen therapy on healing of bedsore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of bedsore degree 1-4 based on classification of world bedsore category, signing written informed consent
Exclusion criteria: Presence of vascular damage such as "Burger Syndrome"
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
3414638588
Approval date
2006-01-10, 1384/10/20
Ethics committee reference number
28/20/2635
Health conditions studied
1
Description of health condition studied
Bed sore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer
Primary outcomes
1
Description
Bed sore size (square cm)
Timepoint
Before intervention and evrey 48 hour for 4 week
Method of measurement
with strerilized ruler( scaled abslang)
Secondary outcomes
empty
Intervention groups
1
Description
Irrigation of ulcer by normal saline solution, topical hyperbaric oxygen 10 /l/min with catheter for 20 min and then dressing by adequate sterile dry gauze, 3 times a day.
Category
Treatment - Other
2
Description
Irrigation of ulcer by normal saline solution, and then dressing by adequate sterile dry gauze, 3 times a day
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali Hospital
Full name of responsible person
Dr Zohal
Street address
Boali Hospital, Boali St.
City
Qazvin
2
Recruitment center
Name of recruitment center
Rajaii Hospital
Full name of responsible person
Dr Ebrahimi
Street address
Rajaii Hospital, Padegan St.
City
Qazvin
3
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Dr Shokouhossadat Abootorabi
Street address
Kosar Hospital, Valiasr St.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra kalantari
Street address
Qazvin University of Medical Sciences
City
Qazvin
Grant name
229
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jalil Azimian
Position
M.A degree, PhD student
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Faculty of Nursing and Midwifery
City
Qazvin
Postal code
34146388588
Phone
+98 28 1223 7267
Fax
+98 28 1223 7268
Email
jazzimian@qums.ac.ir
Web page address
www.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jalil Azimian
Position
M.A Degree, Ph.D student, Acaedemic member
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Nursing and midwifery faculty
City
Qazvin
Postal code
3414638588
Phone
+98 28 1223 7267
Fax
+98 28 1223 7268
Email
jazzimian@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jalil Azimian
Position
M.A.Degree, Ph.D student, Acaedemic member
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qazvin
Postal code
34147388588
Phone
+98 28 1223 7267
Fax
+98 28 1223 7268
Email
jazzimian@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)