Evaluation of the effect of overlapping wound edges with skin graft in reducing hypertrophic scar formation
Design
A clinical trial with a control group, with parallel groups, unblinded, randomized, on 74 patients. The block method will be used for randomization.
Settings and conduct
A study in Imam Reza Birjand Hospital, South Khorasan province, on 74 patients who were divided into two groups of two skin graft methods in a simple random manner. Patients are evaluated at the beginning of the study, 1 and 6 months after the start of the study
Participants/Inclusion and exclusion criteria
Patients admitted to the burn department of Imam Reza Birjand Hospital, who are candidates for graft transplantation, were included in the study in 2023. Inclusion criteria: 2nd and 3rd degree burns, patient consent to enter the study and exclusion criteria: pregnancy, history of chemotherapy, diabetes, substance abuse and receiving systemic drugs such as glucocorticosteroids.
Intervention groups
Burn patients are included in the study. The suitable donor site for the graft is selected by the plastic surgery specialist based on the burn area, thickness and color of the donor site. A skin graft with a thickness of 0.4-0.6 mm will be removed using a rechargeable dermatome and will be transferred to the intended burn site and grafted. The burn sites of the patients are randomly divided into two overlapping techniques and equal to the edges of the wound. In the matching technique with the edges of the burn wound, the area of the harvested tissue is exactly equal to the edges of the wound in the desired location. In the overlapping technique with a margin of 2 mm on each side, repair and grafting is done for patients. Staples are then removed 5 to 10 days after surgery. The preventive treatment of scar compression garments is prescribed for wounds in the same way.
Main outcome variables
Burn scar
pain
General information
Reason for update
Acronym
همپوشانی لبه های زخم با گرافت جلدی در کاهش ایجاد اسکار
IRCT registration information
IRCT registration number:IRCT20190618043934N22
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of overlapping wound edges with skin graft in reducing hypertrophic scar formation
Public title
Evaluation of the effect of overlapping wound edges with skin graft in reducing hypertrophic scar formation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2nd and 3rd degree burns
Patient consent to enter the study
Exclusion criteria:
pregnancy
History of chemotherapy
diabetes
Drug abuse
Receiving systemic medications such as glucocorticosteroids
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in two areas of the total number of burns in the body of patients who are similar in terms of percentage of burns will be selected and will be repaired by two graft methods: 1. Overlapping and 2. Equal to the edges of the burn wound. The selection of the site and repair method is simple random and in a blocked method inside a closed and sealed envelope, which includes the burn site and repair with a graft using the overlapping method (A) or a burn site with a graft using the same method as the edges of the burn wound (A). B) is divided. In this way, various quadruple blocks were created first (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks is randomly selected and the patients are divided into one of two groups A or B. Then randomization is done for other patients as well.
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
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2022-02-28, 1400/12/09
Ethics committee reference number
IR.BUMS.REC.1400.403
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
M61.3
ICD-10 code description
Calcification and ossification of muscles associated with burns
Primary outcomes
1
Description
Pain
Timepoint
The beginning of the study, 1 month and 6 months after the start of the study
Method of measurement
Using a visual pain scale
2
Description
Burn scar
Timepoint
The beginning of the study, 1 month and 6 months after the start of the study
Method of measurement
Using the Vancouver scar scale including four vascular indices, flexibility, pigmentation and the height of the wound edges are evaluated.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1, patients hospitalized in the burn department, candidates for graft transplantation, Imam Reza Birjand Hospital, where the burn site and repair with graft will be done by overlapping method.
Category
Treatment - Surgery
2
Description
Intervention group: Intervention group 2 patients admitted to the burn ward of Imam Reza Birjand Hospital, who are candidates for graft transplantation, where the burn site will be treated with a graft in the same way as the edges of the burn wound.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital-Birjand
Full name of responsible person
Dr Abdollah Adib
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3232 3232
Email
public_r@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr masoud Yousefi
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mahdi Ghoncheh
Position
Member of the Faculty
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Surgery, School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
mahdighoncheh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@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
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available