Comparison of Outcomes of Amniotic Membrane Dressing with Conventional Dressing in Donor Graft Site of Patients with Donor Site of Patients Admitted in Mousavi Hospital, Zanjan
Comparison of the results of two dressing methods with amniotic membrane and classic dressing at the site of harvest in patients admitted to Ayatollah Mousavi Hospital in Zanjan
Design
Randomized clinical trial with control group, single center
Settings and conduct
This research will be conducted in Ayatollah Mousavi Hospital in Zanjan in 1399 as a randomized clinical trial of futuristic two-way blindness in 1398 on patients who have suffered burns or need to be half-skinned due to another disease.
Participants/Inclusion and exclusion criteria
Inclusion
patients who need a semi-thick skin graft for another reason and have a donor site
Donor location in the limbs
No injuries other than burns
General physical and mental health
7 years and 60 years
Trauma, are less than 40 percent of the wound
Exclusion
Patients with blood-borne viral infections
Dissatisfaction of patients
Lack of follow-up
Presence of any cerebrovascular
alcohol and drug abuse
use of antibiotics
use of steroids
Infected patients
Intervention groups
Patients are randomly divided into two groups: the recipient of the classic dressing (Vaseline gas) at the donor site and the amniotic membrane at the donor site.
Main outcome variables
Oscar percentage
Healing rate
Wound healing process
Infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200615047782N1
Registration date:2020-07-09, 1399/04/19
Registration timing:prospective
Last update:2020-07-09, 1399/04/19
Update count:0
Registration date
2020-07-09, 1399/04/19
Registrant information
Name
Salman Sotoudeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 1000
Email address
salman_1238@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Outcomes of Amniotic Membrane Dressing with Conventional Dressing in Donor Graft Site of Patients with Donor Site of Patients Admitted in Mousavi Hospital, Zanjan
Public title
Effect of Amniotic Membrane Dressing in Donor Graft Site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with second- or third-degree burns or patients who need a semi-thick skin graft for any other reason and have a donor site
Donor location in the limbs
No injuries other than burns
General physical and mental health
Age between 7 years and 60 years
Other conditions, such as trauma, are less than 40 percent of the wound and are on the limb and need to be removed
Exclusion criteria:
Patients with blood-borne viral infections including hepatitis B and C and HIV
Dissatisfaction of patients to enter the study
Lack of follow-up ability
Presence of any cerebrovascular, cardiovascular, endocrine, liver and kidney diseases; Pregnancy
History of alcohol and drug abuse
Concomitant use of antibiotics (orally and topically)
Concomitant use of steroids or immunosuppressive drugs
Infected patients at the donor site
Age
From 7 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
We will assign participants in study group using random blocks (each block size =4). Considering A and B as interventions for participants, we could have six blocks each have 2 A and 2 B (AABB, ABAB, ABBA, BABA, BBAA, BAAB). Ten block will be selected randomly (by rand function of Microsoft Excel) and we will recruits the participants according to final order.
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 Ethics Committee
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
11345678
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.ZUMS.REC.1399.056
Health conditions studied
1
Description of health condition studied
Patients suffered thermal burns in need skin graft
ICD-10 code
X09
ICD-10 code description
Exposure to unspecified smoke, fire and flames
Primary outcomes
1
Description
Scar percentage
Timepoint
The amount of scar on the fifth, fourteenth, and finally thirty-sixth days is evaluated as outpatient in the clinic by the relevant professor and its amount is recorded with a qualitative scale of 4 items: excellent, good, average, weak.
Method of measurement
A measure of the body's scar level that is measured objectively
2
Description
Healing rate
Timepoint
The time required for wound healing on the fifth, fourteenth, and finally 30th days of the clinic is evaluated on an outpatient basis by the relevant professor and its amount is recorded with a qualitative scale of 4 items: excellent, good, average, weak.
Method of measurement
Healed: the wound area where the medicine wasapplied is completely healed ObviouslyEffective:70 % of the wound is healed Effective: over 30 % of the wound is healed Ineffective: the effective standard is not met
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention sites with a thickness of 0.4 to 0.6 mm are given using an electric dermatome with the same level of oxidation; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is randomly covered with an amniotic membrane. Amniotic membrane is taken from sero negative mothers who accepted to deliver their tissue as Volunteer. Then biologic dressing is covered by strile gauze.
Category
Treatment - Other
2
Description
Control group: The control group of control locations are both given a thickness of 0.4 to 0.6 mm using an electric dermatome with equal levels in both groups of oxions; Bleeding is controlled using epinephrine 1 in 50,000 with sterile gauze. One of the donor sites is accidentally covered with ordinary dressing, ie Vaseline gas (control group).In the control group, the cover is done directly with Vaseline gas. In the control group, the dressing is done with Vaseline gas and it will not be touched for 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Mohammad Hossein Moghimi
Street address
Ayatollah Mousavi Hospital
City
Zanjan
Province
Zanjan
Postal code
11234567
Phone
+98 24 3313 0001
Email
salman_1238@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Gavazang road
City
Zanjan
Province
Zanjan
Postal code
1123456789
Phone
+98 24 3313 0001
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Hosein Moghimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mousavi hospital, Gavazang road
City
Zanjan
Province
Zanjan
Postal code
1123456789
Phone
+98 24 3310 0001
Email
Mohammadhosein_moghimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Hosein Moghimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mousavi hospital, Gavazang road
City
Zanjan
Province
Zanjan
Postal code
1123456789
Phone
+98 24 3313 0001
Email
Mohammadhosein_moghimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Hossein Moghimi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Mousavi hospital, Gavazang road
City
Zanjan
Province
Zanjan
Postal code
1123456789
Phone
+98 24 3313 0001
Email
Mohammadhosein_moghimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as the original or similar information, can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only scientific use of data is possible
From where data/document is obtainable
Salman sotoudeh
Salman_1238@yahoo.com
What processes are involved for a request to access data/document
Data files will be received by the applicant within a maximum of three days