Evaluation of efficacy and side effects of chitosan alginate dressings in chronic wound heal in patients refer to shohadaye tajrish hospital during two years
In this trial chitosan and alginate which are produced in Europe are mixed with different proportions and chitosan-alginate dressing is formed.Then it is compared with traditional dressing used routinely in chronic ulcer treatment; these dressings are sterilized by different beams and then in open-label trial in Shohadaye Tajrish hospital, 32 patients are enrolled in our trial and randomely assigned to two groups. First group treated with chitosan-alginate dressing and the second one with traditional dressing. In first visit after gathering information we take photograph of their ulcer and dressing is placed and changes every 48-72 hours. In each visit photographs are taken from the ulcers. Follow up continuous until 4 weeks after healing of the ulcer. Images are evaluated by two dermatologists who are unaware of treatment groups and adverse effects and degree of remission are assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041927480N1
Registration date:2017-01-07, 1395/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Yasaman Ketabi
Name of organization / entity
Shahid beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 22292895
Email address
yketabi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Skin disease research center, Shohadaye Tajrish hospital
Expected recruitment start date
2016-09-19, 1395/06/29
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and side effects of chitosan alginate dressings in chronic wound heal in patients refer to shohadaye tajrish hospital during two years
Public title
Evaluation of efficacy and side effects of chitosan alginate dressings in chronic wound heal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years old; chronic wound with duration more than 4-6 weeks; wound diameter 1-200 square centimeter; consent for entering trial.
Exclusion criteria: refuse to enroll; allergy to shellfish, lobster; attending other trials; pregnancy; lactation; severe co-morbidity; collagen vascular ulcers or severe infected ulcers.
Age
From 18 years old to 99 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
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
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo blvd., Velenjak