This study compares the effect of hydrocolloid dressing and silver nanoparticles on the healing of pressure ulcers in patients with spinal cord injuries with pressure ulcers grade 2 and 3 who were admitted in university hospitals in Tehran. Inclusion criteria are: patients with pressure ulcers grade 2 and 3, age 18 to 65 years, lack of infection in the wound, lack of necrotic tissue, patients who are willing to be changing position every hour and no use of other dressings. Exclusion criteria are: occurrence of malnutrition in the study; surgical Wound; lack of patient cooperation; changing position every hour for more than 10 times during the study and discharge from the hospital before the change in the stage of wound. Characteristics of lesions in 120 patients with BWAT tool will be evaluated. The dressing will be administered by the manufacturer guideline and wound healing evaluation is performed by a process in which the partner does not know the type of dressing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112038286N1
Registration date:2011-12-11, 1390/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-11, 1390/09/20
Registrant information
Name
Fatemeh Bahramnezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
fatemeh_bahramnezhad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hydrocolloid dressing and silver Nano particles in the healing of pressure ulcers in patients with spinal cord injuries
Public title
Pressure ulcer & dressing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with pressure ulcers grade 2 and 3; age 18 to 65 years; lack of infection in the wound or necrotic tissue; patients who are willing to be changing position every hour and no use of other dressings. Exclusion criteria: occurrence of malnutrition in the study; surgical Wound; lack of patient cooperation; changing position every hour for more than 10 times during the study and discharge from the hospital before the change in the stage of wound
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences
Street address
6th floor, Centeral building of Tehran University of Medical Sciences, Ghods St, Keshavarz BLD.
City
Tehran
Postal code
Approval date
2011-11-01, 1390/08/10
Ethics committee reference number
90/130/1561
Health conditions studied
1
Description of health condition studied
Pressure Ulcer
ICD-10 code
L89.9
ICD-10 code description
Decubitus ulcer and pressure area, unspecified
Primary outcomes
1
Description
Duration of recovery
Timepoint
After each dressing change
Method of measurement
jJensen wound assessment tool or pressure sore status tool
2
Description
The depth of the wound
Timepoint
After each dressing change
Method of measurement
Jensen wound assessment tool or pressure sore status tool
3
Description
Money spent for dressing change
Timepoint
After each dressing change
Method of measurement
They calculated the total number of dressings and Price
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group (Silver nano-particles) were dressed according to the manufacturer's (How to change, time and frequency of dressing changes) instructions they receive, and depth of wound, duration of wound healing with BWTA will be evaluated
Category
Treatment - Drugs
2
Description
In the control group (Hydrocolloid) were dressed according to the manufacturers (How to change, time and frequency of dressing changes) instructions they receive, and depth of wound, duration of wound healing with BWTA will be evaluated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roghayeh Karimi
Street address
6th floor,Centeral building of Tehran University of Medical Sciences, Ghods St, Keshavarz BLD.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
MSc
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st, Tohid sq
City
Tehran
Postal code
Phone
+98 21 6690 4252
Fax
Email
fatemeh_bahramnezhad
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Zolfaghari
Position
PhD
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st, Tohid sq
City
Tehran
Postal code
00982166904252
Phone
+98 21 6690 4252
Fax
Email
Zolfaghm@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Bahramnezhad
Position
MSc
Other areas of specialty/work
Street address
Nursing & Midwifery School, East Nosrat st, Tohid sq
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)