Determining and comparing the incidence of infection in repaired wound wounds with different dressing models in the emergency room
Design
Clinical trial on patients with limb ulcers after wound healing with three different dressing models (saline plain dressing group, vaseline dressing group and local tetracycline antibiotic gas dressing group) randomized without blinding, phase 3 on Rand function of Excel software was used on 150 randomized patients.
Settings and conduct
Patients after dressing the wound after randomization, are dressed with three different models and are examined for infection up to 7 days after the initial dressing for wound infection.
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Participants/Inclusion and exclusion criteria
Inclusion criteria::
Patients with limb wounds who are admitted to the emergency room of Khatam Al-Anbi Hospital for wound healing.
Exclusion criteria:
Patients receiving antibiotics while taking injectable antibiotics.
Wounds that have healed in more than one layer.
People with immunodeficiency / chronic corticosteroids / DM
Wounds caused by animal bites
Wounds with fractures
People under the age of 18 and over the age of 60
People with chronic internal diseases (RF / RA / SLE / endocrine disorders)
dirty wounds
Wounds that have been repaired in other centers and referred to the emergency room of Khatam Al-Anbia Hospital for dressing.
People with malnutrition, obesity and smoking
Intervention groups
A simple saline-impregnated dressing group, a vaseline dressing group, and a gas-dressing group impregnated with topical tetracycline antibiotics.
Main outcome variables
Wound infection (yes / no)
Follow-up time (daily up to 7 days after wound healing)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054869N1
Registration date:2022-06-07, 1401/03/17
Registration timing:registered_while_recruiting
Last update:2022-06-07, 1401/03/17
Update count:0
Registration date
2022-06-07, 1401/03/17
Registrant information
Name
ali abdolrazaghnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3323 2890
Email address
ali.abdolrazaghnejad@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2022-12-07, 1401/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the incidence of infection of repaired wound wounds with different dressing models in the emergency room
Public title
Evaluation and comparison of the incidence of infection of repaired wound wounds with different dressing models in the emergency room
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with limb wounds who are admitted to the emergency room of Khatam Al-Anbi Hospital for wound healing.
Exclusion criteria:
Patients receiving antibiotics while taking injectable antibiotics.
Wounds that have healed in more than one layer.
People with immunodeficiency / chronic corticosteroids / DM
Wounds caused by animal bites
Wounds with fractures
People with chronic internal diseases (RF / RA / SLE / endocrine disorders)
Clearly dirty wounds
Complex, crushed and twisted wounds
The size of the wounds is more than 20 cm
Wounds that have been repaired in other centers and referred to the emergency room of Khatam Al-Anbia Hospital for dressing.
Patients who have referred for wound healing for more than 6 hours
People with malnutrition, obesity and smoking
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
.Random allocation of patients to two groups is done by permuted block stratified randomization. In this way, first, the eligible patients are classified according to age and sex, respectively. Then, based on 6 blocks (consisting of three groups A, B and C and two repetitions for each) that are randomly selected from all possible modes of permutations, they are assigned to the desired group. These blocks are created using R statistical software version 4.0.2. These codes are located in a sealed package to hide the allocation in the envelope, which will be assigned to patients in order.
Matching
The two groups are matched in terms of age and sex (Frequency matching) using the permutation block stratified randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst are unaware of the types of interventions (different dressing models).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Daneshgah blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.ZAUMS.REC.1401.062
Health conditions studied
1
Description of health condition studied
Sutured wound infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound infection (having or not having)
Timepoint
Daily up to 7 days after the initial dressing
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dressing with sterile gauze impregnated with saline. Put a layer of 0.9% saline-impregnated gas on the wound and then put a layer of dry sterile gas on it and fix it on the skin with glue. We change the dressing for up to 7 sessions daily.
Category
Prevention
2
Description
Intervention group: Gas stove to Vaseline. Put a layer of Vaseline impregnated gas on the wound and then put a layer of dry sterile gas on it and then fix it on the wound with glue. We change the dressing up to 7 times a day.
Category
Prevention
3
Description
Intervention group: Gas tetracycline-impregnated topical antibiotic gas. Apply a layer of tetracycline topical antibiotic-impregnated gas to the wound, then apply a layer of dry sterile gauze, and then fix the adhesive to the wound. We change the dressing up to 7 times a day.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-al-anbia hospital
Full name of responsible person
ali abdolrazaghnejad
Street address
khatam square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3223 2890
Email
ali.abdorazzagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
normohammad bakhshani
Street address
Daneshgah blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3323 2890
Email
ali.abdorazzagh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
ali abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Daneshgah blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3323 2890
Email
ali.abdorazzagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
ali abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
daneshgah blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3323 2890
Email
ali.abdorazzagh@gamil.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Abdolrazaghnejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Khatam-al-anbia
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3323 2890
Fax
Email
ali.abdolrazaghnejad@zaums.ac.ir
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers, including in laboratory and scientific institutions.
Under which criteria data/document could be used
In order to use the data in research work and after sending the request, if the researcher agrees, the data responsible will be provided to the applicant.
From where data/document is obtainable
Correspond with the responsible researcher (Ali Abdolrazaqnejad) via email.
What processes are involved for a request to access data/document
After submitting the request, the applicant will have access to the data up to 1 month after the request, if he / she meets the conditions.