Assessment of the efficiency of polysaccharide homeostasis powder in trauma patients of RAJAEI Hospital
Design
The present study is a single-blinded, stratified randomized controlled clinical trial with two arms in trauma patients over the age of 18 at shiraz Rajaei Hospital during the year 1400. For 192 samples, the randomization is done with a table of random numbers in three layers (skin, liver, abdomen) and two groups ( case and control) .
Settings and conduct
At Rajai Trauma Hospital in Shiraz, depending on the size of the wound, 1 to 5 grams of powder is sprayed to the bleeding site (the maximum allowed in a patient is 50 grams). The location of the wound and other information, including the effectiveness of the powder will be recorded. We check blood clot formation after 3 and 5 minutes of spraying. During a check, the spraying is repeated if the powder has been removed. Control group members follow the same powder-free steps using dry gauze and pressure. We count Gauze numbers with at least 50% bloody appearance. In the following days, the wound's surface is evaluated for tissue reactions and possibly powder residues (Also if the wound is reopened).
The TBS (Target bleeding site) and Surface Bleeding Severity Scale (SBSS) and the rate of hemostasis are used to report data.
Participants/Inclusion and exclusion criteria
Trauma patients over 18 years of age, with stable clinical conditions and non-infectious wounds, who did not have underlying renal, hepatic, diabetic, or coagulation disorders are included in the study.
Intervention groups
Intervention group: Trauma patients with mild to moderate bleeding wounds that the powder is used to control bleeding according to the instructions.
Control group: Similar patients but without the use of control powder for bleeding
Main outcome variables
Bleeding control time; Bleeding volume; Surgeon satisfaction; The rate of gross tissue reaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121117011491N3
Registration date:2021-11-12, 1400/08/21
Registration timing:prospective
Last update:2021-11-12, 1400/08/21
Update count:0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Hamid Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 8728
Email address
mohammadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-21, 1400/08/30
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the efficacy of new hemostatic polysaccharide powder to control bleeding in acute traumatic patients
Public title
Evaluation of the effect of new polysaccharide homeostasis powder in controlling bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Accepting and signing the informed consent of the patients' legal guardian to allow the use of the powder produced in controlled conditions for the patient
Existence of ulcers with mild to moderate bleeding with stable vital sign
Age more than 18 years
Liver and Pelvic damage without peritoneal perforation
Exclusion criteria:
Infectious or contaminated wounds with soil or abdominal contents
Peritoneal perforation
Diabetes
Renal or Liver failure
Past medical history of Hypersensitivity (Hospitalization or hypotension due to drug anaphylaxis)
Past medical history of Autoimmune or Immunodeficiency disease or disorder
Severe Malnutrition
Hereditary coagulation disorder or severe coagulation disorders that prevent patients from the operation
Gall bladder laceration of rupture
uncontrolled shock state
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
192
More than 1 sample in each individual
Number of samples in each individual:
2
Skin, Live, and abdominal laceration may be seen in a patient that each lesion can be nominated as a sample
Randomization (investigator's opinion)
Randomized
Randomization description
The stratified randomization method is used in this study. In order to achieve a balance , blocks with size of 4, 6 and 8 are used.
For randomization tools, online sources of random table generation have been used, and the generated tables comply with the following specifications.
Here are the specifications used to create this table.
Block sizes: 4,6,8
Actual list length: 190
Stratification factors: Site (Liver, Abdomen, Skin)
Treatment group: Group A, Group B
Allocation concealment will be used for concealment and will only be revealed when the patient is assigned to a patient group in the operating room. This is done using sealed envelopes that cannot be read from the outside; the envelope will be opened by the operating room in charge at the moment of surgery and the patient group will be identified. It is impossible to guess the group based on the envelope number since envelopes are randomly numbered.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the use of powder and lack of access to similar powders, double-blinding is not possible. Statisticians are unaware of the groups, but surgeons are. It is discussed with all patients that the powder will be used, but they don't know if it has been used. A patient does not notice that the powder was used during anesthesia because the wounds close as well. The analyst will be unaware of the two groups and analyzes will be conducted in two groups without drug specifications.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee School of Medicine - Shiraz University of Medical Sciences
Street address
Setad
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-09-06, 1400/06/15
Ethics committee reference number
IR.SUMS.MED.REC.1400.340
Health conditions studied
1
Description of health condition studied
bleeding
ICD-10 code
R58
ICD-10 code description
Hemorrhage, not elsewhere classified
Primary outcomes
1
Description
The rate of successful hemostasis
Timepoint
Record of hemostasis status at 3 and 5 minutes since powder spray time
Method of measurement
Recording the amount of residual bleeding based on the Surface Bleeding Severity Scale at 3 and 5 minutes after powder spraying
2
Description
Wound bleeding volume before reaching homeostasis
Timepoint
5 minutes after STARTING THE WOUND EVALUATION
Method of measurement
The number of sterile gauze consumed with more than 50% bleeding
Secondary outcomes
1
Description
Gross tissue reaction
Timepoint
One to three days after powder application as daily record
Method of measurement
Depending on the severity of the tissue reaction, the wound reaction is graded from one to six. Scoring one means there is no obvious tissue reaction, and scoring six means there is necrosis at the wound site. Data entry forms include this scoring system and the registering user check the appropriate grade.
Intervention groups
1
Description
Intervention group: Control bleeding in wounds with moderate or mild bleeding by modified and sterile polysaccharide powder, produced by Knowledge-based Healda Company and Shiraz University of Medical Sciences, with one to 5 grams depending on the size of the wound beside all common methods that are used to control bleeding. The powder may be used one to three times. The powder is biocompatible and biodegradable and is used in trauma patients in operating rooms under sterile conditions.
Category
Treatment - Drugs
2
Description
Control group: Trauma patients with mild to moderate bleeding wounds use gauze and pressure as a common method of bleeding control to control their bleeding. No placebo was used for these patients.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Hospital
Full name of responsible person
Hamid Mohammadi
Street address
Chamran Blv
City
Shiraz
Province
Fars
Postal code
7187757184
Phone
+98 71 3647 4298
Email
mohammadi219@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzadeh
Street address
Shiraz university of medical science central building , Zand Street
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
rezaeenz@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Unit 10, Golfam Building ,Golha av , Moaali Abad av
City
Shiraz
Province
Fars
Postal code
7187757184
Phone
+98 71 3623 1557
Fax
+98 71 3647 4298
Email
mohammadi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Unit 10, Golfam Building, Golha av, Moaali Abad av
City
Shiraz
Province
Fars
Postal code
7187757184
Phone
+98 71 3623 1557
Fax
+98 71 3647 4298
Email
mohammadi219@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Unit 10, Golfam Building, Golha av, Moaali Abad av
City
Shiraz
Province
Fars
Postal code
7187757184
Phone
+98 71 3623 1557
Fax
+98 71 3647 4298
Email
mohammadi219@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