Compared celox with using a compression bandage and compression bandage alone at time of bleeding control in patients with penetrating wounds of the extremities
In this randomized clinical trial on patients with penetrating trauma will be done during the study period, patients with penetrating wounds from knives, glass and car accidents with intentional or unintentional mechanism of injury to Imam Hossein hospital will be divided into experimental and control conditions. Inclusion criterias in the study were penetrating wounds in the extremities, aged 18 to 50 years, and lesion with length greater than 3 cm and less than 15 cm.
Celox to the extent required in the experimental group and the control group plus pressure dressing will be used to stop bleeding. Duration of time to bleeding control will be recorded. In order to measure of the amounts of bleeding after treatment, 10 × 10 eight layers of celox gases that are used to control bleeding counts, blood-stained gas equivalent to 20 cc of blood are considered.
Other variables such as demographic data and vital signs, methods and extent of hydration of patients in both groups will be determine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104206238N1
Registration date:2014-04-15, 1393/01/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Hamid Reza Hatamabadi
Name of organization / entity
Shahid Beheshti University of edical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 73430
Email address
hhatamabadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor forr Research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-03-13, 1392/12/22
Expected recruitment end date
2014-08-01, 1393/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compared celox with using a compression bandage and compression bandage alone at time of bleeding control in patients with penetrating wounds of the extremities
Public title
Compared celox with pressure bandages at time of bleeding control in penetrating extremity wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Penetrating wounds in extrimities with sharp objects and accidental or non accidental mechanism of injury.
2- Age 18 to 50 years
3- Length of lesion greater than 3 cm and less than 15 cm.
Exclusion criteria:
1- Foreign body in ulcer
2- There are coagulation defects and anticoagulation drugs
3- The patient has hypovolemic shock
4- The same material used to control clotting
5 - The patients needs to receive blood or blood products
Age
From 18 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahid Beheshti University of Medical Scinces
Street address
Tabnank St, Yaman St, Shahid Chamran highway
City
Tehran
Postal code
1985717443
Approval date
2012-07-08, 1391/04/18
Ethics committee reference number
121
Health conditions studied
1
Description of health condition studied
Open wound of upper and lower extrimity
ICD-10 code
T11/1-T13/
ICD-10 code description
open wound of upper and lower extrimity
Primary outcomes
1
Description
Time to achieve control of bleeding
Timepoint
5 min and 10 min
Method of measurement
hour
Secondary outcomes
1
Description
Bleeding volume
Timepoint
5 min and 10 min
Method of measurement
Numbers dipped in blood gas celox
Intervention groups
1
Description
compression bandage gases typical 10 × 10 eight layers after 5 and 10 minutes were reviewed and any gas-blood equivalent to 20 cc of blood
Category
Treatment - Other
2
Description
compression bandage gases typical 10 × 10 eight layers after 5 and 10 minutes were reviewed and any gas-blood equivalent to 20 cc of blood and
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Hamid Reza Hatamabadi
Street address
Shahid Madani St, Immam Hosein hospital,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hamid Reza hatamabadi
Street address
Tabnak St, Yaman St, Shahid Chamran highway Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research of Shahid Beheshti University of Medical Sciences