Comparison the effect of regular dressing and Acticoat on wound healing and pain in patients admitted to hospital for treatment of burns at Clinic Vali Asr (aj), Arak 2010-2012
Introduction: One of the new treatments in burn is producing of dressing by using Nanotechnology. This study compared the effects of silver sulfadiazine 1% cream and Acticoat dressing on burn wound healing. Methods: This randomized, controlled trial was done in vali Asr Hospital of Arak city in Iran. The patients were randomly divided into two equal groups: group I (n = 32), treated topically with silver sulfadiazine 1% cream and group II (n = 32), control group, treated topically with Acticoat dressing. Wound healing process wsa examined using the wound assessment tool of Bats-Jensen. Analysis of variance REMANOVA was used to evaluate the differences of wound healing parameters between treated and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123111940N2
Registration date:2013-09-07, 1392/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Azam Malek Hoseini
Name of organization / entity
Arak University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1226 7892
Email address
m.saeedi@arak.ac.ir
Recruitment status
Recruitment complete
Funding source
All costs were provided by the researcher
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of regular dressing and Acticoat on wound healing and pain in patients admitted to hospital for treatment of burns at Clinic Vali Asr (aj), Arak 2010-2012
Public title
The effect of Acticoat and usual dressing on Wound healing and burnt patients’ pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: all burn patients with the following conditions have been chosen as examples: 1)the subjects burned grade 2, grade 3, or a combination, of less than 15% body surface area burns were. 2) ulcer patients not treated with contaminated materials. Before entering the study, samples of any substance other than potable water were not used on wounds. 3) All subjects before entering the study were infected symptomatic of the body. 4) None of the participants in the research underlying immune deficiency diseases such as diabetes, cancer, AIDS, and high blood pressure. .... Did not. 6) willingness to participate in the study were injection molded, and able to answer questions.
Exclusion criteria were: 1) Patients who were admitted to the burn unit. 2) After approval of the study, patients were withdrawn from treatment. 3) In case of any allergies or sensitivity to drug treatment. 4) In case of any signs of wound infection in spite of treatment.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Islamic Azad University of Medical Sciences
Street address
Tehran, Shariati St, zargandeh, Islamic Azad University, Tehran Medical Unit
City
Tehran
Postal code
00981916893813
Approval date
2009-09-23, 1388/07/01
Ethics committee reference number
123-8-234
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20-25
ICD-10 code description
Burns and corrosions of external body surface, specified by site
Primary outcomes
1
Description
Wound healing
Timepoint
days 1, 7 and 15
Method of measurement
The wound assessment tool Baets - Jensen
2
Description
Pain at dressing change
Timepoint
Days 1,7 and 15
Method of measurement
Using the Numeric Pain tool
Secondary outcomes
1
Description
Pain
Timepoint
days 1, 7 and 15
Method of measurement
Using the Numeric Pain tool
Intervention groups
1
Description
The experimental group was treated with Acticoat dressing l for two weeks
Category
Treatment - Drugs
2
Description
The control group was treated with Sulfadiazine 1% for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital
Full name of responsible person
Azam Malekhoseini
Street address
Thirty yards Ayatollah Ghafari St., Vali Asr (aj)
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Tehran Medical Branch
Full name of responsible person
Dr. Syed Shahabuddin Mohseni
Street address
Tehran Medical Branch , Islamic Azad UniversityT, khaghani st, shariati Ave , Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Tehran Medical Branch
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
Arak University of Medical Sciences
Full name of responsible person
Azam malekhoseini
Position
MS in nursing
Other areas of specialty/work
Street address
Thirty yards Ayatollah Ghafari St., Vali Asr (aj)
City
Arak
Postal code
3817834467
Phone
+86 12267892
Fax
Email
malekhoseni.aram@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
arak university of medical science
Full name of responsible person
Azam malekhoseini
Position
MS in Nursing
Other areas of specialty/work
Street address
Bsyh Square, site Sardasht, School of Nursing and Midwifery
City
Arak
Postal code
38481-7-6941
Phone
+86 12267892
Fax
Email
Account Optionsmalekhoseni.aram@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak university of medical science
Full name of responsible person
Azam malekhoseini
Position
MS in Nursing
Other areas of specialty/work
Street address
Bsyh Square, site Sardasht, School of Nursing and Midwifery
City
Arak
Postal code
38481-7-6941
Phone
+86 12267892
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)