The effect of traditional dressing and amniotic dressing on the repair of facial superstructuration
Design
This study is a prospective clinical trial consisting of 24 patients with facial abrasion, which will be conducted by oral and maxillofacular surgery (OMFS) of Velayat and Poursina hospitals during 1401. The transplant method used (traditional or amniotic membrane) will be explained in detail for each patient individually, including benefits, disadvantages, and informed written consent will be taken from everyone. Patients will be randomly divided into two groups (each group of 13 patients). A group of people receiving standard or traditional treatment (control group). And the other group of people whose wounds will be covered with amniotic membrane and will be treated (intervention group). In the amniotic group, the transplant will be placed on the wound bed and then the dressing will be performed for 2 weeks. Amniotic membrane sticks to the wound bed when placed on the wound and there will be no need for stitches. Patients will be examined by an OMFS specialist on days 4, 7, 14 and 30 and the thickness of scars will be evaluated by Vancouver scar scale. Itching ratings from 0 (no itching) to 4 (severe itching) will be done by the same specialist. The collected data will be analyzed in IBM SPSS Statistics software version 26 at a significant level of 5%.
Settings and conduct
Velayat Burn Center
Participants/Inclusion and exclusion criteria
Patient with facial abrasion
Intervention groups
Patient with facial abrasion. In this group, patients are candidates for traditional dressing and amniodon dressing.
Main outcome variables
The intensity of itching, degree of pain, and incidence of infection (days 4, 7, 14)
General information
Reason for update
Acronym
HAM
IRCT registration information
IRCT registration number:IRCT20221116056518N1
Registration date:2022-11-29, 1401/09/08
Registration timing:registered_while_recruiting
Last update:2022-11-29, 1401/09/08
Update count:0
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
Rahman Hosseini Karizomr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7795 8432
Email address
s.rahman.hosseiny@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of traditional dressing and aminiotic dressing on facial abrasion repair: a randomized control trial
Public title
Facial abrasions and amniotic membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
... Emergency department admission less than 24 hours after the incident
Satisfaction with participating in the study
Ages between 18 and 60
Facial ulcers at least 15% of the surface of the skin on the patient's face
Exclusion criteria:
late referral
history of heart, kidney, diabetes and other metabolic organs (e.g. thyroid, pituitary, etc.)
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to allocate patients to intervention and control groups, resticted randomization approach will be used in parallel with block randomization method. We will consider the blocks as a 4-size random. The allocation ratio of samples will be (1:1) and will be in two groups of control and intervention. Then, based on the obtained blocks and sequencing, allocation of dressings will be placed on patients in the control and intervention group. To generate random numbers, various packages in R software will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
namjoo street, rasht, guilan
City
Rasht
Province
Guilan
Postal code
1111-1111
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.GUMS.REC.1401.409
Health conditions studied
1
Description of health condition studied
Facial abrasion
ICD-10 code
T14.0
ICD-10 code description
Superficial injury of unspecified body region
Primary outcomes
1
Description
The intensity of itching
Timepoint
(days 4, 7, 14)
Method of measurement
Itching ratings from 0 (no itching) to 4 (severe itching) will be done by the same specialist
2
Description
degree of pain
Timepoint
(days 4, 7, 14)
Method of measurement
Pain Score on a scale of one to ten by patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This study is a prospective cohort consisting of 24 patients with ulcers, which will be conducted by the Department of Oral and Maxillofacial Surgery (OMFS) of Porsina Hospital during the year 1401. The method of implantation used (conventional or amniotic membrane) will be explained in detail to each patient individually, including advantages, disadvantages, and written informed consent will be obtained from all. Patients will be randomly divided into 2 groups (12 people in each group). A group of people receiving standard or traditional treatment (control group). and another group of people whose wound will be covered with amniotic membrane and treated (intervention group). Permission for all stages of this study will be obtained from the university ethics committee. In the intervention group, after cleaning the wound surface with normal saline serum and separating foreign bodies (if any), washing with 0.9% normal saline and then biological dressing (amnion) will be done. Amnion biological surrogate (mother's pair) is used for non-diseased and healthy mothers after elective caesarean section in Al-Zahra Hospital. According to health protocols for mothers, blood samples are sent to the laboratory to check for HCV, HBS and HIV. The embryonic layers of the placenta are separated under the hood and then washed under sterile conditions with Ringer's solution, and the amnion layer is separated and transferred to sterile containers (4°C). In order to remove blood and other contaminants, it is washed four times with normal saline and then once with 0.25% sodium hypochlorite solution and washed again with normal saline. Then the samples are transferred to the refrigerator in sterile containers.To rule out bacterial contamination, routine cultures are performed from the stored membranes. Amniotic curtains should be prepared no later than 12 hours after delivery, and after freezing and drying, they can be stored for about a year. Regarding the placement of the amnion membrane, care must be taken to ensure that the lower layer, which has the ability to multiply, is placed on the wound and that the tissue is not placed on the wound from behind. Then dressing will be done for 2 weeks on days 4, 7 and 14. When the amniotic membrane is placed on the wound, it will stick to itself and there will be no need for stitches. Pieces of amniotic membrane measuring 1-2 x 3-5 cm can be selected depending on the size and extent of the wound.Patients will be examined by an OMFS specialist at intervals of 1 month, 2 months, and 6 months, and the thickness of the scars will be evaluated with the Vancouver scar scale (VSS). Also, the rating of itching from 0 (no itching) to 4 (severe itching) will be done by the same expert.
Category
Treatment - Surgery
2
Description
Control group: In this study, the control group will receive standard treatment. This treatment includes using gentamicin ointment or tetracycline for decontamination, sutures if necessary, and then covering wounds with wet-to-dry dressing in this method after one week, the dressing is removed and after pulling the sutures, the person will be prescribed anti-scar ointment.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Burn Center
Full name of responsible person
Rahman Hosseini Karizomr
Street address
Velayat Hospital, Namjoo Street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
S.rahman.hosseiny@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Deputy of Research and Technology, in front of 17 Shahrivar Hospital, Namjo St
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Rahman Hosseiny kariz omar
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Namjo St, Velayat Hospital
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8540
Email
S.rahman.hosseiny@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Rahman Hosseiny kariz omar
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 21 7795 8432
Fax
Email
s.rahman.hosseiny@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Rahman Hosseini Karizomr
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 21 7795 8432
Fax
Email
s.rahman.hosseiny@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available