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Evaluation of the therapeutic effect of dressing containing Silver(Ag coat) in the process of healing skin blisters caused by limb fractures

Protocol summary

Study aim
Evaluation of the therapeutic effect of dressing containing Ag coat in the process of healing skin blisters caused by limb fractures
Design
The therapeutic research plan was to use two types of dressings containing silver and gaz vaseline and to compare the size of the wound surface , the rate of recovery, pain, visit time and cost,over time. 40 patients referred to Kashani Hospital in Isfahan. They were randomly selected and randomly assigned to silver dressing and vaseline gaz dressing groups using secret random cards.
Settings and conduct
This study was conducted on patients with skin blisters caused by bone fractures in Kashani Hospital, Isfahan. Blister areas were photographed on days 0, 7, and 14 and compared by mosaic software. Also, the amount of pain was compared by the Vas questionnaire, the time of visit and number of dressing, and cost of dressing between the two groups. Participants were blinded to grouping.
Participants/Inclusion and exclusion criteria
all patients with blister due to bone fracture, aged between 18-65 and Consent to participate in the study.
Intervention groups
Among the 40 selected patients, 31 patients were divided into two groups of 15 people with silver dressing (case) and 16 people with Vaseline gas (control) according to the entry and exit criteria. The wound surface of the patients was photographed by a photographer based on protocol and analyzed by Mosaic software.
Main outcome variables
wound area, duration of visit, Number of dressings,Net cost of dressing, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221207056744N1
Registration date: 2023-01-08, 1401/10/18
Registration timing: registered_while_recruiting

Last update: 2023-01-08, 1401/10/18
Update count: 0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Sahar Lalehzar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 6684
Email address
saharsadatlalehzar4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-03, 1401/10/13
Expected recruitment end date
2023-08-12, 1402/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of dressing containing Silver(Ag coat) in the process of healing skin blisters caused by limb fractures
Public title
Therapeutic effect of dressing containing silver on skin blister
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with blister due to bone fracture aged between 18-65 years old Consent to participate in the study
Exclusion criteria:
Sensitivity to silver Amputation indication patients who did not agree to participate in the study those who did not participate in the study until the end and did not come for follow-up sessions
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
This is a pioneering randomized trial that compares the effectiveness of two dressings containing silver(Ag coat) and gaz vaseline among patients with skin blisters caused by bone fractures who were randomly selected from patients referred to the Kashani Medical Training Center. After the selection, the participants were randomly assigned to the experimental and control groups using lottery cards, so that the results of their allocation to the groups were accessible only after the completion of the initial evaluations by the research staff.
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 isfahan university of medical science
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Services, central headquarters
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.MUI.MED.REC.1401.025

Health conditions studied

1

Description of health condition studied
blister due to bone fracture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
wound area
Timepoint
Measurement of wound area at the beginning of the study (before the intervention), day 7 and day 14
Method of measurement
Taking a photo of the wound at a distance of 15 cm and perpendicular to the wound and analyzing it using the mosaic software.

Secondary outcomes

1

Description
pain
Timepoint
Measurements on day 0, 7 and 14
Method of measurement
VAS score questioner

2

Description
Duration of visit
Timepoint
Measurements on day 0, 7 and 14
Method of measurement
The length of time that the wound specialist visits the patient to change the dressing

3

Description
Number of dressings
Timepoint
From day 0 to day 14
Method of measurement
Counting the number of dressings by a wound expert

4

Description
Net cost of dressing
Timepoint
From day 0 to day 14
Method of measurement
The price of the total number of dressings used in the entire 14 days of the study

Intervention groups

1

Description
Intervention group: Intervention group: silver dressing (Ag coat) was placed on the blister for 14 days and changed every one week. On days 0, 7, and 14, blisters were photographed. Wound area was calculated by mosaic software and size changes were measured over time.
Category
Treatment - Drugs

2

Description
Control group: Vaseline gaz dressing was placed on the blister for 14 days and changed every day. On days 0, 7, and 14, blisters were photographed. Wound area was calculated by mosaic software and size changes were measured over time.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Kashani Hospital
Full name of responsible person
Mehdi Teimouri
Street address
Isfahan - Kashani St. - Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
8184854783
Phone
+98 31 3235 6684
Email
saharsadatlalehzar4@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Isfahan University of Medical Sciences and Health Services, central headquarters ,Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 6684
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan university of medical science
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Mehdi Teimouri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Kashani Hospital ,Kashani St.
City
Isfahan
Province
Isfehan
Postal code
8184854783
Phone
+98 31 3235 6684
Email
mteimouri@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar sadat Lalehzar
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Isfahan, Felezi bridge, Motahari street, Mahstan residential complex, ground floor unit
City
Isfahan
Province
Isfehan
Postal code
8184854783
Phone
+98 31 3235 6684
Email
saharsadatlalehzar4@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sahar sadat Lalehzar
Position
general practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Isfahan, Felizi bridge, Motahari street, Mehstan residential complex, ground floor unit
City
Isfahan
Province
Isfehan
Postal code
8184854783
Phone
+98 31 3235 6684
Email
saharsadatlalehzar4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available to everyone
Under which criteria data/document could be used
There will be no special condition
From where data/document is obtainable
Sahar sadat Lalehzar saharsadatlalehzar4@gmail.com
What processes are involved for a request to access data/document
There will be no special process, we will respond only by sending an email
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