This study is a double blind clinical trial to determine the effect of silicone protective pad on pressure ulcers in patients undergoing coronary artery bypass surgery. Criteria for inclusion included : 1.Age 75-30 years 2. Connect to pump circulation outside the body, Exclusion criteria included: 1. Long operation time more than 5 hours 2. emergency surgery.
The sample size n = 82 for each group have been calculated. In the intervention group, of a silicone protective pad with length 90 width 60 thickness of 3.5 cm for pressure sores during the operation in the area of the sacrum and hips, which is the most common location of pressure ulcers,in hospital operating room Madani martyr in year 95- 94 will be used. The most important outcome of this study is to reduce the incidence of pressure ulcers in patients undergoing coronary artery bypass surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110619919N3
Registration date:2016-04-11, 1395/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-11, 1395/01/23
Registrant information
Name
Arefeh Davoodi Bavil Oliaii
Name of organization / entity
Nursing and Midwifery of Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
adavoodi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Tabriz University of Medical Sciences
Expected recruitment start date
2016-01-22, 1394/11/02
Expected recruitment end date
2017-01-21, 1395/11/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of silicone protective pad on pressure ulcers in patients undergoing coronary artery bypass
Public title
The effect of silicone protective pad on pressure ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Willingness to participate in the study and signed an informed consent form; Age 75-30 years; Undergo bypass surgery for first time; No history of blood disorders; Having BMI 18.5 to 24.9; Connect to pump circulation outside the body; No history of bedsores.
Exclusion criteria: Long operation time more than 5 hours; emergency surgery; Having skin problems such as hives, swelling, redness and sensitivity to drugs and environmental factors in the area of Batks; Having Sensorimotor disability[Such as stroke].
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
164
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The way of randomization is the blocking method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
University Street, University round, tabriz
City
Tabriz
Postal code
Approval date
2016-01-07, 1394/10/17
Ethics committee reference number
TBZMED.REC.1394.974
Health conditions studied
1
Description of health condition studied
Patients undergoing cardiac surgery
ICD-10 code
100-199
ICD-10 code description
120-125
Primary outcomes
1
Description
Reduce the incidence of pressure ulcers
Timepoint
Befor intervention, 24 and 48 hour after intervention and the time of discharge
Method of measurement
The measure Torrance Scale.
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 1: In the intervention group, silicone protective pad with length of 90,width of 60 and a thickness of 3.5 cm for the prevention of pressure ulcers during surgery on the sacrum and hip area will be used.
Category
Prevention
2
Description
Cntrol group: The control group will not be any interference and these groups will receive the same care and routine Intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Afkham Vargaeei
Street address
University Street, University round, tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi Mohammad Reza
Street address
University street, University round,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tabriz 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
School of Nursing and Midwifery- University of Medical Sciences
Full name of responsible person
Aghal Moosa
Position
MSc student- Expert
Other areas of specialty/work
Street address
School of Nursing and Midwifery- South Shariati- Shariati Square- tabriz
City
Tabriz
Postal code
Phone
+98 45323199
Fax
Email
Aghalm6768@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Position
instructor, MSc
Other areas of specialty/work
Street address
The end of South Shariati street, Faculty of Nursing and Midwifery- South Shariati Ave
City
Tabriz
Postal code
Phone
+98 41 3477 0648
Fax
Email
arefehdavoodi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery- University of Medical Sciences
Full name of responsible person
Arefeh Davoodi
Position
Istructor- MSc
Other areas of specialty/work
Street address
The end of shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3477 0648
Fax
Email
Arefehdavoodi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)