The purpose of this study is comparison between effect of Alpha and Silver Sulfadiazine ointments in treatment of burned patients. In this study we compare difference of wound healing, scar formation, infection, pain scale, analgesic receipt and days of hospitalization in patient who are treated with Alpha and Silver Sulfadiazine ointments.
Our study is a prospective study which is a Randomized Clinical Trial. This study was done on 20 patient with two upper or two lower limb burning, where in each patient; one limb dressed with Alpha ointment and the other limb was dressed with Silver Sulfadiazine ointment.
Patients with inclusion criteria which was second degree burning and burning surface between 10% to 20% enter to this study. In these patient we choose the patients who had two burned limb. Some patients exclude from study by exclusion criteria which was old burning and other medical diseases.
In all, 20 patient with 40 burned limb was studied.
We dressed all wounds once a day with 20 milligrams of each ointment for every 1% of burning wound. In the first and 7th and 14th day of burning we got cultures from wounds swaps, and in the 7th and 14th and 30th day we evaluate the healing of wounds through photogeraphy and objective evaluation.
In 30th day of burning we evaluate scar of wounds in the patients for compare between Alpha and Silver Sulfadiazine ointments wounds.
Patients’ pain scale was assessed with Visual Analog Scale (VAS) in first fourteen days of admit. And use or do not use of pethidine analgesia in first fourteen days of admit was evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110624905N1
Registration date:2016-02-09, 1394/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
Payman Sadri
Name of organization / entity
Zanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 0651
Email address
sadrip@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2014-09-27, 1393/07/05
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between effect of Alpha and Silver Sulfadiazine ointments in treatment of burned patients
Public title
The effect of alpha ointment in treatment of burned patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Second degree heat burned patients; burning surface area between 10% and 20%
Exclusion criteria:Iisolated head and neck burning; burning of genitalia; pregnant women; first and third and fourth degree burning; unstable patients; burning surface area above 20% or under 10%; patients with history of neurocycotic diseases who are under treatment; addiction to opioids; smokers; patients with history of cardiac, renal or hepatic diseases; diabetic patients; malnutrished patients; patients under treatment of corticosteroids or other immune suppressive treatments; inhalative burnings; sulfunamid toxicity; old burnings
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Science
Street address
Central office of Zanjan University of Medical Science, Azadi Blvd, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2014-09-14, 1393/06/23
Ethics committee reference number
ZUMS.REC1393.199
Health conditions studied
1
Description of health condition studied
Burning
ICD-10 code
X10; X11;
ICD-10 code description
Contact with hot drinks, food, fats and cooking oils; Contact with hot tap-water; Contact with other hot fluids
Primary outcomes
1
Description
Rate of ulcer healing
Timepoint
Seventh, 14th, 30th day
Method of measurement
Evaluation of patient in the admission time and evaluation of ulcers in 7th and 14th day of admission and out patient in day 30th. In every visit photography of ulcers was done.
2
Description
The rate of scar
Timepoint
Thirtieth day
Method of measurement
Two other colleagues who were not aware of our protocol, visited patients in 30th day and scored rate of scar in 4 qualitative scale item like excellent, good, intermediate, poor. And the remaining scar was reported in percentage.
3
Description
The rate of positive culture
Timepoint
First, 7th, 14th day
Method of measurement
The cuture of wound swap in the first, 7th and 14th day of admission.
Secondary outcomes
1
Description
The rate of patients' pain
Timepoint
Daily
Method of measurement
VAS (visual analogue scale) in first 14 day
2
Description
Dose of recieved analgesia
Timepoint
Daily
Method of measurement
Evaluation of pethidine consumption in firs 14 day
3
Description
Days of admission
Timepoint
Daily
Method of measurement
Questionnarie
Intervention groups
1
Description
Patients in the burning ward, was treated accidentally with Alpha ointment which made in Rejoderm company and Silver Sulfadiazine ointment which made in Sina Darou company. In this study we choose patients with two burned limbs and if they were compatible with our criterias, the intervention was done in two separate limbs where one limb dressed with Alpha and the other limb was dressed with Silver Sulfadiazine. Dressing of wounds was done daily after washing of the wounds with sterile Normal Saline serum. Every one percent of wounds was macerated with twenty Gram of Alpha or Silver Sulfadiazine ointment. We used vaseline gauzes to cover the Alpha ointment dressings and sterile gauzes to cover the Silver Sulfadiazine dressings. Then these dressings was fixed with cotton bands. Dressing of wounds was continued until epithelialization of whole wounds.
Category
Treatment - Drugs
2
Description
Because this study was done over patients with two burned limbs, in all patients one limb accidentally was dressed with Alpha ointment and the other limb was dressed with Silver Sulfadiazine ointment.