Protocol summary

Summary
Aim of this study is to compare the efficacy of nano crystalline silver dressings ‎compared with ‎conventional dressings in patients with impaired upper limb ‎crushed fingers. This study is clinical trials and double blind. Inclusion criteria: age ‎‎18 to 70 years with Finger injury with damage to the muscle of the ‎upper limb; ‎crush injury in ‎10 to20 centimeter in muscles. Exclusion criteria: involvement of ‎tendons, blood vessels, muscles, nerves and bones at the site of damage; systemic ‎diseases such as cardiovascular disease, metabolic disorders, collagen vascular, ‎immunosuppression (diabetes, transplant) malignant; inflammatory and ‎infectious diseases at the same time; malnutrition (important in wound healing); ‎addiction; pregnancy; breastfeeding; need for limb amputation; Loss of ‎consciousness and traumatic brain injury; need for further surgery on the wound; ‎history of skin allergy to silver; infected wounds before applying the dressing at first ‎stage. there are 70 patients . We will divide patients in to two groups randomly. ‎We treat 35 patients with nano crystalline silver in intervention group. We treat 35 ‎patients with normal wound dressing in control group. We will follow the wound improvement ‎at the end of first, second, third and fourth visits (4 times) after surgery. We will follow-up by phone.‎

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021520258N33
Registration date: 2017-03-06, 1395/12/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-06, 1395/12/16
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and research, Arak University of Medical Sciences
Expected recruitment start date
2016-06-14, 1395/03/25
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the efficacy of nanocrystalline silver dressings compared with ‎conventional dressings in patients with impaired upper limb crushed fingers
Public title
Compare the efficacy of nanocrystalline silver dressings compared with ‎conventional dressings in patients with impaired upper limb crushed fingers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 70 years with Finger injury with damage to the muscle of the ‎upper limb; crush injury in ‎10 to20 centimeter in muscles. Exclusion criteria: involvement of tendons, blood vessels, muscles, nerves and bones at the site of damage; systemic diseases such as cardiovascular disease, metabolic disorders, collagen vascular, immuno suppression (diabetes, transplant) malignant;   inflammatory and infectious diseases at the same time; malnutrition (important in wound healing); addiction; pregnancy; breastfeeding; need for limb amputation;Loss of consciousness and traumatic brain injury; need for further surgery on the wound; history of skin allergy to silver; infected wounds before applying the dressing first stage
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
‏1395.98. ‏IR.ARAKMU.REC‏

Health conditions studied

1

Description of health condition studied
Crush injury
ICD-10 code
S57
ICD-10 code description
Crushing injury of forearm

Primary outcomes

1

Description
Improving wound
Timepoint
End of first, second, third and fourth (4 times) after surgery
Method of measurement
Clinical

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: applying nano crystalline silver in intervention group.
Category
Treatment - Drugs

2

Description
Control group: applying normal wound dressing in control group.‎
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Amani
Street address
Valiasr Hospital, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
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, Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Gharibi
Position
Faculty, Emergency Medicine Specialist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr square, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
gharibi@arakmu.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Amani
Position
Faculty, Orthopedic
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
amani@arakmu.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Sarkheil
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 863222003
Email
sarkheil@arakmu.ac.ir
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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