Comparison of the therapeutic effect of amniotic membrane dressing with silver sulfadiazine ointment dressings in the management of superficial burns wounds, second degree of trunk and limb Ayatollah in Mousavi Hospital of Zanjan in 2016-2017
The overall objective of the project: to determine the treatment effect compared amniotic membrane dressing with silver sulfadiazine ointment dressings in superficial second degree burn wounds.
Study design: Randomized Clinical Trial.
Inclusion criteria: all patients with superficial thermal burns grade 2 less than 20% and no burns isolated to the head and neck; lack of burn areas genitalia; stable vital signs; no history of psychiatric disorders in patients with burns; the absence of drug and psychotropic; smoking, no history of heart, kidney and liver problems; no diabetes; no history of malnutrition; not taking corticosteroids or drugs that suppress the immune system; lack of burns inhalation; no history for sulfonamides toxicity; no previous burns in the recent burn site; no evidence of infection in burns and age over 18 years in patients presenting to the emergency department or clinic.
Exclusion criteria: allergic reaction to silver sulfadiazine ointment; side effects or sensitivity to amniotic membrane dressing; requirement to wound debridement in the operating room.
Sample size: The formula seems adequate number of patients in each group of 18 people but we have 25 patients in each group (groups) will be studied.
Intervention: in the intervention group burn used dressing with amniotic membrane.In the control group burn used dressing with Gauze soaked with siver sulfadiazine ointment.
Intervention period: one month.
Result of studied: the pain and analgesic consumption and the amount of scarring and infection; wound healing and dressing; and the cost and number of days of hospitalization in hospital has been compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110824947N1
Registration date:2017-02-06, 1395/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Mehran Salehian
Name of organization / entity
Departmen of surgery, Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
mehran.salehian@gmail.com
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of amniotic membrane dressing with silver sulfadiazine ointment dressings in the management of superficial burns wounds, second degree of trunk and limb Ayatollah in Mousavi Hospital of Zanjan in 2016-2017
Public title
Burn dressing with amniotic membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients wit; superficial thermal burns grade 2 less than 20% and no burns isolated to the head and neck; lack of burn areas genitalia; stable vital signs; no history of psychiatric disorders in patients with burns; the absence of drug and psychotropic; smoking, no history of heart, kidney and liver problems; no diabetes; no history of malnutrition; not taking corticosteroids or drugs that suppress the immune system; lack of burns inhalation; no history for sulfonamides toxicity; no previous burns in the recent burn site; no evidence of infection in burns and age over 18 years in patients presenting to the emergency department or clinic. Exclusion criteria: allergic reaction to silver sulfadiazine ointment; side effects or sensitivity to amniotic membrane dressing; requirement to wound debridement in the operating room.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Postal code
Approval date
2016-12-20, 1395/09/30
Ethics committee reference number
IR.ZUMS.REC.1395.226
Health conditions studied
1
Description of health condition studied
Degree 2 burn wounds
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Epithelializasion
Timepoint
Seven days, 14 days and 30 days after intervention (dressing with amniotic membrane)
Method of measurement
Based on the physical examination
2
Description
Wound infection
Timepoint
Daily visits during hospitalization and based on clinical evidence and cultivation of bending if positive clinical evidence (fever, discharge and cellulite)
Method of measurement
Clinical descriptions of daily visits
3
Description
Analgesia Consumption
Timepoint
Daily during admission
Method of measurement
Medical records
4
Description
Frequency of dressing exchange
Timepoint
From first until 30th day of the study
Method of measurement
The number of dressing exchange
Secondary outcomes
1
Description
Wound scar
Timepoint
30 days after the intervenion
Method of measurement
Physical examination (0 = no scar; 1 = mild ; 2 = moderate ; 3 = severe
2
Description
Pain
Timepoint
The seventh day after the intervention (dressing with amniotic membrane or silver sulfadiazine ointment)
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
In the intervention group burns area are dressing with amniotic membrane
Category
Treatment - Other
2
Description
In the control group burns area are dressing with gauze soaked with silver sulfadiazine ointment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi hospital
Full name of responsible person
Dr. Mehran Salehian
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan Universiy of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi blvd.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Universiy 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
Zanjan Universiy of Medical Sciences
Full name of responsible person
Dr Mehran Salehian
Position
MD
Other areas of specialty/work
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
mehran.salehian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Surgery, Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hosein Moghimi
Position
General Surgeon
Other areas of specialty/work
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
Mohammadhosein_moghimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan Universiy of Medical Sciences
Full name of responsible person
Dr. Mehran Salehian
Position
MD
Other areas of specialty/work
Street address
Mousavi hospital, Gavazng road
City
Zanjan
Postal code
Phone
+98 24 3313 0001
Fax
Email
mehran.salehian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)