Determining the effect of active adhesive hydrogel consisting of polyacrylamide, hydroxyethyl cellulose, and polyquaternium 7 in second degree wound healing
Design
A clinical trial of drugs with two control and intervention groups, randomized with online software, phase 3 on 30 patients
Settings and conduct
The intervention groups are treated for 14 days with dressing changes every other day. After receiving explanations at Dr. Soltani's clinic and training on how to use them, photos of the wound healing process are taken every other day. Then, the surface of the wounds is analyzed by ImageJ software.
Participants/Inclusion and exclusion criteria
The conditions for entering/exiting the study are as follows:
Inclusion criteria: male and female patients with second-degree skin ulcers are included in the study.
Exclusion criteria: patients with diabetes, HIV, diseases and problems of the immune system, pregnant women, lactating women or those who intend to become pregnant, uncontrolled infection and people with various skin sensitivities.
Intervention groups
The control group received a conventional silver-impregnated dressing
The intervention group receiving active hydrogel dressing
Main outcome variables
Acceleration of skin wound healing compared to the control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060864N1
Registration date:2024-02-19, 1402/11/30
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Farjam Goudarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 521 6837
Email address
farjam.goudarzi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-18, 1403/01/30
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Active adhesive hydrogel as second grade wound dressing
Public title
Adhesive hydrogel for wound dressing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients include men and women with second-degree skin ulcers
Exclusion criteria:
Diabetes
HIV
Diseases and problems of the immune system
Pregnancy
Lactating or those planning to become pregnant
Uncontrolled infection
All types of skin allergies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used using blocks of 4. A third person who is not involved in the process of diagnosing and evaluating patients will create a random sequence using the site: https://www.sealedenvelope.com and the number of blocks will be determined based on the sample size. Each patient will be given a unique code that can be created on this site. Therefore, concealment is observed and the people involved in the study do not know in which group the next person will be placed and they will not know about the random sequence; Only the statistics consultant will know about the random sequence and the codes will remain with them.
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 Kermanshah Medical Sciences
Street address
Beheshti BLVD
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Approval date
2024-01-16, 1402/10/26
Ethics committee reference number
IR.KUMS.REC.1402.503
Health conditions studied
1
Description of health condition studied
Second degree skin wound
ICD-10 code
T14.1
ICD-10 code description
Open wound of unspecified body region
Primary outcomes
1
Description
The rate of skin wound closure compared to the control group
Timepoint
14 days
Method of measurement
Photographing the wound and analyzing it semi-quantitatively with ImageJ software
Secondary outcomes
1
Description
skin itching
Timepoint
During the intervention
Method of measurement
Oral
2
Description
Erythema
Timepoint
During the intervention
Method of measurement
Oral
3
Description
Dry skin feeling
Timepoint
During the intervention
Method of measurement
Oral
Intervention groups
1
Description
Control group: In this group, common commercial dressings that are dry and impregnated with silver are used. These dressings only play the role of preventing infection by silver and isolating the wound environment from the surrounding atmosphere.
Category
Treatment - Devices
2
Description
Intervention group: In this group, the unique hydrogel of this study is used for volunteers. This dressing is placed on the wound so that it covers the wound. Then they are changed every other day for 14 days.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Keyvan Soltani's specialized clinic
Full name of responsible person
Dr. Keyvan Soltani
Street address
Saadi Street Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 918 339 4870
Email
farjam.goudarzi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
Building No. 2 Medical Sciences - Research and Technology Vice-Chancellor,Shahid Beheshti Blvd. , Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
research_it@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farjam Goudarzi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Faculty of Medicine, Razi Blvd., Kermanshah, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 919 521 6837
Email
farjam.goudarzi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farjam Goudarzi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Razi Blvd. Faculty of Medicine
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 919 521 6837
Email
farjam.goudarzi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farjam Goudarzi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Faculty of Medicine, Razi Blvd., Kermanshah, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 919 521 6837
Email
farjam.goudarzi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of people's information and the possibility of commercialization of the dressing, it is not possible to share data