Evaluation of the effectiveness of silver containing hydrocolloid dressings in the treatment of the donor site of partial- thickness skin grafts
Design
This study is a clinical trial with a control group, with parallel, double-blind and randomized groups on 30 patients. Block randomization method is used for randomization.
Settings and conduct
First, the partial- thickness skin grafts removed with an electric dermatome
The donor site is then covered with epinephrine-impregnated gas at 1 in 100,000 until proper homeostasis is established. In the next step, patients are randomly divided into two groups: Hydrocolloids containing silver are made under the Aquacel Ag brand. In the first group, the donor site is first placed on the wound with a gas soaked in Vaseline and then bandaged with one or two layers of dry gas and a crepe bandage.
In the second group, the donor site is done with Aquacel Ag dressing with dimensions of 15 by 15 cm or 20 by 30 cm, depending on the dimensions of the wound and according to the manufacturer's instructions, then one or two layers of dry gas are placed on this dressing and Finally, the crepe bandage is done. This study is performed in Hazrat Fatemeh Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who need partial partial- thickness skin grafts to repair skin defects for various reasons
Exclusion criteria: Patients who do not wish to participate in the study
Patients with previously known allergies to silver
Intervention groups
Intervention group: Patients undergoing Doner Wound treatment of partial- thickness skin grafts with silver-containing hydrocolloid dressings
Control group: Patients undergoing treatment of Doner Wound treatment of partial- thickness skin grafts by traditional dressing
Main outcome variables
The degree of adhesion of the dressing to the wound bed, wound infection, wound healing process
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054168N1
Registration date:2022-03-03, 1400/12/12
Registration timing:prospective
Last update:2022-03-03, 1400/12/12
Update count:0
Registration date
2022-03-03, 1400/12/12
Registrant information
Name
Amirali Mirfakhraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
dr.mirfakhraee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of silver-containing hydrocolloid dressings in the treatment of donor wounds of partial- thickness skin grafts
Public title
The effect of hydrocolloid dressing in the treatment of skin graft wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need partial partial- thickness skin grafts to repair skin defects for various reasons
Exclusion criteria:
Patients who do not wish to participate in the study
Patients with previously known allergies to silver
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.
To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks.
For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit.
Here, based on the block 4, we divide patients into groups.
1. TTCC 2. TCTC 3. TCCT
4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B
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 Sciences
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14496145351
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
Patients with skin defects
ICD-10 code
A66.2
ICD-10 code description
Other early skin lesions of yaws
Primary outcomes
1
Description
The degree of adhesion of the dressing to the wound bed
Timepoint
After dressing the wound up to 14 days after dressing
Method of measurement
Standard checklist
2
Description
Wound infection
Timepoint
After dressing the wound up to 14 days after dressing
Method of measurement
Standard checklist
Secondary outcomes
1
Description
wound healing process
Timepoint
After dressing the wound up to 14 days after dressing
Method of measurement
Standard checklist
Intervention groups
1
Description
Intervention group: First, the partial- thickness skin grafts removed with an electric dermatome.The location of the donor, the thickness of the skin removed, and the dimensions of the skin removed are recorded for each patient. Donor injection is not performed at the donor site before removal.The donor site is then covered with epinephrine-impregnated gas at 1 in 100,000 until proper homeostasis is established. In the next step, the donor site is done with Aquacel Ag dressing made by ConvaTec company with dimensions of 15 by 15 cm or 20 by 30 cm, depending on the dimensions of the wound and according to the manufacturer's instructions, then one or two layers of dry gas are placed on this dressing and Finally, the crepe bandage is done.
Category
Treatment - Devices
2
Description
Control group: First, the partial- thickness skin grafts removed with an electric dermatome.The location of the donor, the thickness of the skin removed, and the dimensions of the skin removed are recorded for each patient. Donor injection is not performed at the donor site before removal.The donor site is then covered with epinephrine-impregnated gas at 1 in 100,000 until proper homeostasis is established. In the next step, the donor site is first placed on the wound with a gas soaked in Vaseline and then bandaged with one or two layers of dry gas and a crepe bandage.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Amir Ali Mirfakhraei
Street address
Seyed Jamaluddin Asadabadi St.Twenty-first Street, next to Shafaq Park
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
Dr.mirfakhraee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosein Keyvani
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Email
keyvani.h@iums.ac.ir
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 Mirfakhraei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8871 7272
Email
Dr.mirfakhraee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
AmirAli Mirfakhraei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8871 7272
Email
Dr.mirfakhraee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
AmirAli Mirfakhraei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8871 7272
Email
Dr.mirfakhraee@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