Protocol summary

Study aim
Assessment of the effectiveness of hydrocolloid, silver containing dressing in the treatment of split thickness skin graft donor site
Design
Two arm Clinical trial, with a control group, with parallel groups, double-blind, on 42 patients This study includes two groups of 21 people who are assigned to each group based on the inclusion and random criteria. It is used to randomize the table of random numbers.
Settings and conduct
The study is carried out in two groups of 21 people who undergo half-thickness skin removal from the thigh area at Tehran Hazrat Fatemeh Hospital. In both groups, the skin is treated with electric tools. Then, the harvesting areas in the intervention group are dressed with silver-containing hydrocolloid dressing, and in the control group, they are dressed in the traditional way with petroleum jelly. The wound healing process and the final wound scar in two groups are investigated and compared. During the procedure, only the main researcher, who also performs the dressing, is aware of the type of dressing. But the patients, the wound care, the person who evaluates and records the findings, and the person who is in charge of the statistical analysis, none of them will have any information about the way of dressing in each person or even in each group.
Participants/Inclusion and exclusion criteria
Patients above 18 and under 60 years old who need to harvest skin graft
Intervention groups
In the intervention group, hydrocolloid dressing containing silver is used, and in the control group, traditional dressing (Vaseline gas) is used for dressing.
Main outcome variables
Wound infection, speed of wound healing, frequency of need for dressing, pain when changing dressing, final scar of wound

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221210056768N1
Registration date: 2022-12-14, 1401/09/23
Registration timing: prospective

Last update: 2022-12-14, 1401/09/23
Update count: 0
Registration date
2022-12-14, 1401/09/23
Registrant information
Name
Amirali Mirfakhraee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 3050
Email address
ahiakhanahmadi1985@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of hydrocolloid, silver containing dressing in the treatment of partial thickness skin graft donor sites.
Public title
Silver containing dressing in wound management.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo split thickness skin graft Age above 18, and under 60 No interfering medical conditions Getting the informed consent
Exclusion criteria:
Age under 18, or above 60 Reluctance of the patient Any significant morbidity such as uncontrolled diabetes
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way. Patients who meet the inclusion criteria will receive one of two different types of dressings. Of course, only the researcher will know the type of dressing used and the randomization sequence. Patients, nurses who provide care services, evaluators, and ultimately data analysts will not be aware of these things.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know the type of dressing used on the wound. The nurse who performs the service of changing the external layers of the dressing is not aware of the type of the main dressing used in the lower layer. The evaluator of the results who checks the results after removing the dressing does not know what type of dressing was used in each person. The data analyst does not know who the control group and the control group are
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Iran university of medical science, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1916953576
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.IUMS.FMD.REC.1400.609

Health conditions studied

1

Description of health condition studied
final scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin

2

Description of health condition studied
Reepithelialization rate
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The final scar of the wound - at the end of the first and sixth months, the quality of the scar and the scar score are evaluated based on the Vancouver scar measurement criteria, and the average scar score in the two groups is compared.
Timepoint
After 1 month, and 6 months
Method of measurement
According to the Vancouver Scar Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Using the hydrocolloid, silver containing dressing in the treatment of split-thickness skin graft donor site
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Saint Fatima, plastic and reconstructive surgery hospital
Full name of responsible person
Amirali Mirfakhraee
Street address
21 Alley, Yousefabad Ave.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2249 3050
Email
ahiakhanahmadi1985@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Abbaszade
Street address
Iran university of medical science, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۲۳۴۵۶۷۸۹۰
Phone
+98 21 2249 3050
Email
ahiakhanahmadi1985@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Amirali Mirfakhraee
Position
Subspecialty student
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No 78, Heidari Ave, Zargande
City
Tehran
Province
Tehran
Postal code
۱۲۳۴۵۶۷۸۹۰
Phone
+98 21 2249 3050
Email
ahiakhanahmadi1385@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Akhoondi nasab
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
21 Alley, Yousefabad Ave.
City
Tehran
Province
Tehran
Postal code
۱۲۴۴۵۶۷۸۹۰
Phone
+98 21 2249 3050
Email
ahiakhanahmadi1985@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amirali Mirfakhraee
Position
Subspecialty student
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No78, Heidari Ave, Zargande
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2249 3050
Fax
Email
ahiakhanahmadi1985@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the variables for each individual will be published, as well as the demographic information of each individual. All findings and documents, except identity information, can be published.
When the data will become available and for how long
The findings will be available three months after the publication of the results.
To whom data/document is available
All academic researchers, and commercial users and employers in the field of wound healing products can use this data.
Under which criteria data/document could be used
The use of data and results is unimpeded under any circumstances, citing the source.
From where data/document is obtainable
I, Dr. Amir Ali Mirfakhrai, as the main person in charge of the project, am ready to share the data. Applicants can send their application to the email address Dr.mirfakhrae@gmail.com.
What processes are involved for a request to access data/document
After sending the application to the mentioned email, the data will be sent to the applicant within 2 weeks.
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