Protocol summary

Study aim
Determining the consequences of washing and wound healing using tap water compared to sterile normal saline in soft tissue tears in Patients referred to the hospital's emergency room
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized by block method on 240 patients
Settings and conduct
The study is conducted in the emergency department of Madani Karaj Hospital. People with soft tissue tears meet the entry criteria and according to the Suture procedure, before repair, the wound is washed with tap water or normal saline. Using tap water with a gavage syringe, a sterile receiver, and a volume equal to normal saline serum (half a liter per 10 cm).The study is open label.
Participants/Inclusion and exclusion criteria
Patients referred to emergency room, Karaj Madani Hospital, over 18 years of age, with no history of taking antibiotics and immunosuppressive drugs, are included in the study؛ and if the exclusion criteria include: People who have cardiovascular diseases such as varicose veins and DVT at the beginning of the study and have blood supply disorders؛ People who have any underlying disease that weakens the immune system (for example, diabetes mellitus, chronic alcoholism, asplenism, primary immune disorder, use of steroids or chemotherapy) ؛People who are currently or recently taking antibiotics. have had biotics؛ Chronic wounds such as bedsores or diabetic foot ulcers and vascular and varicose wounds؛ Punctured or bitten wounds؛ Tendon ruptures or bone fractures؛ Wounds that have been created for more than 6 hours
Intervention groups
In the intervention group, wound washing for the suture procedure is done with tap water and in the control group with sterile normal saline.
Main outcome variables
Age؛ sex؛ wound site infection؛ wound healing time؛ wound length

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240613062112N1
Registration date: 2024-06-18, 1403/03/29
Registration timing: prospective

Last update: 2024-06-18, 1403/03/29
Update count: 0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
Mohammad mahdi khanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2219 2750
Email address
mahdiyarkhanzaadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-06, 1403/04/16
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of wound washing and repair using tap water compared to sterile normal saline in soft tissue lacerations in patients
Public title
Comparison of the results of wound washing and repair using tap water compared to sterile normal saline in soft tissue tears in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than or equal to 18 years Clean or relatively clean wounds without crushing or scratching with an indication for a suture procedure in the emergency room Not taking antibiotics and immunosuppressive drugs recently
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used for randomization. The length of the block for each of the treatment groups is considered to be 4, that is, each block will include two people from the intervention group and two people from the comparison group. If the people of the group Indicate the intervention with the letter A and the people of the comparison group with the letter B. In this case, according to the formula . then for Each of these blocks will generate random codes. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, eligible people will be assigned to treatment or comparison groups. This random process of selecting blocks and assigning people to intervention and comparison groups It will continue until reaching the desired sample size This method solves the problem of imbalance that can occur in simple randomization.
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
Research Ethics Committees of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, North Taleghani Boulevard, Karaj, Alborz Province
City
Tehran
Province
Tehran
Postal code
3149779453
Approval date
2024-06-09, 1403/03/20
Ethics committee reference number
IR.ABZUMS.REC.1403.070

Health conditions studied

1

Description of health condition studied
Lacerations of soft tissues
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Wound site infection
Timepoint
1, 2, 3, 5 days after the procedure
Method of measurement
Observation and doctor's examination

2

Description
Site of wound
Timepoint
When performing the procedure
Method of measurement
Asking the person and observation the doctor

3

Description
Repair and healing time
Timepoint
From 3 to 14 days depending on the location of the wound
Method of measurement
Doctor's clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Washing with tap water in order to repair the wound with sutures
Category
Treatment - Surgery

2

Description
Control group: Washing with normal saline sterile in order to repair the wound with sutures
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Zabihollah taleshi
Street address
Madani hospital, jahanshahr, karaj
City
Karaj
Province
Alborz
Postal code
3143744693
Phone
+98 26 3443 4700
Email
zabitaleshi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Raziyeh Lotfi
Street address
Alborz university of medical sciences, west boali, Karaj
City
Karaj
Province
Alborz
Postal code
۳۱۹۸۷۶۴۶۵۳
Phone
+98 26 3464 3705
Email
mahdiyarkhanzaadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Zabihollah taleshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Madani hospital, jahanshahr, karaj
City
Alborz
Province
Alborz
Postal code
3143744693
Phone
+98 26 3443 4700
Email
zabitaleshi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Zabihollah taleshi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Madani hospital, jahanshahr, karaj
City
Alborz
Province
Alborz
Postal code
3143744693
Phone
+98 26 3443 4700
Email
zabitaleshi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad mahdi Khanzadeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
No 4, yas Ave, Merhaban Ave, Artesh blvd, mini city
City
Tehran
Province
Tehran
Postal code
1955898331
Phone
+98 21 2219 2750
Fax
Email
Mahdiyarkhanzaadeh@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
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