Objectives: Evaluation the effect of Sucralfate 15% gel on degree I & II bedsore, in Sari Imam Khomeini hospital's patients
Design: Parallel, double blind, placebo control, clinical trial
Setting and conduction: In this study 30 cases and 30 controls of bedridden patients with bedsore will enroll accidentally to the study.
Participants: Inclusion criteria:
All of patients that have bedsore I &II degree; base on American Society of Anesthesiology protocols
Exclusion criteria: Adverse reaction to the product; Or the bedsore degree increase to III and IV
Intervention: During 7 days, all of the patients, will receive normal treatment including: frequent change position, daily washing and dressing, also case group will receive Sucralfate 15% gel and control group will receive placebo.
Main outcomes: Each day ulcer will observe for discharge, color and size (Based on PUSH tool)
.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107053014N5
Registration date:2012-05-02, 1391/02/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-02, 1391/02/13
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
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
Investigating the effect of sucralfate 15% gel in decreasing of bedsore degree I & II , in bedridden patients of Sari Imam Khomeini hospital.
Public title
Investigating the effect of sucralfate 15% gel in decreasing of bedsore degree I & II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of patients that have bedsore I &II degree; base on American Society of Anesthesiology protocols
Exclusion criteria: Adverse reaction to the product; Or the bedsore degree increase to III and IV
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics department of Mazandaran University of Medical Sciences
Street address
Ethics department of Mazandaran University of Medical Sciences, Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, sari, Mazandaran, Iran
City
Sari
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
203
Health conditions studied
1
Description of health condition studied
Bedsore
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Discharge
Timepoint
7 days
Method of measurement
drainage
2
Description
Ulcer size
Timepoint
7 days
Method of measurement
ruler
3
Description
Ulcer color
Timepoint
7 days
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
There are 30 case with bedsore rank 1 or 2 in this study that will receive Sucralfate 15% gel during 7 days. Then the ulcer will observe for size, color and discharge.
Category
Treatment - Drugs
2
Description
There are 30 control with bedsore rank 1 or 2 in this study that will receive placebo gel during 7 days. Then the ulcer will observe for size, color and discharge.