Peritendinous adhesions after repair of an injury to the digital flexor tendons are a major problem in hand surgery. Nonsteroidal anti inflammatory drugs therapy may affect tendon healing and the development of peritendinous adhesions. Aim of this study is evaluation of Ibuprofen effect in patients function and prevent of tissue adhesions after flexor tendon surgical repair. In this clinical trial study, 60 patients with sharp laceration in zone two of the hand that need to repair of flexor tendon will be evaluated. Patients divided randomly in two parallel groups (30 patients in each group) and matched with together according to age, sex and size of laceration. Patients in control group will receive placebo in same shape and size. In intervention group patients will receive Ibuprofen (2400mg per day). Patients will be excluded if they had previous flexor tendons injury or gastrointestinal disease. Tendon adhesion and flexor tendons function will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301189857N2
Registration date:2013-02-14, 1391/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-14, 1391/11/26
Registrant information
Name
Ali Tabrizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 7183
Email address
tabrizia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ibuprofen therapy effect in prevent of tissue adhesion after flexor tendon repair in zone two of hand
Public title
Evaluation of medical therapy in improvement of hand tendons function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 60 years.
Laceration in vollar hand in zone two.
Exclusion criteria:
patients with cardiovascular or gastrointestinal disease,
patients with previous flexor tendons injury or surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this clinical trial study, patients will be divided in two parallel groups with simple random sampling. Patients will be received ibuprofen in intervention group and placebo in control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Tabriz University of Medical Sciences
Street address
Golgasht Ave, Tabriz Medical Faculty
City
Tabriz
Postal code
Approval date
2012-12-26, 1391/10/06
Ethics committee reference number
25/ب/91
Health conditions studied
1
Description of health condition studied
Tendon Injury
ICD-10 code
M65-M68
ICD-10 code description
Other contracture of tendon
Primary outcomes
1
Description
Flexor tendons function
Timepoint
Each two weeks
Method of measurement
Measurement of involved finger motion
2
Description
Tendon rupture
Timepoint
End of follow up
Method of measurement
Assay tendon motion clinically
Secondary outcomes
1
Description
Tissue adhesion
Timepoint
End of follow up
Method of measurement
By full moving the fingers and hands
2
Description
The need for further surgery
Timepoint
End of study
Method of measurement
Limitation of motion
Intervention groups
1
Description
Patients in interventional group will be received ibuprofen 2400 mg produced by Zahravy pharmaceutical companies in every day for a month.
Category
Treatment - Drugs
2
Description
Patients in control group will be received placebo in same shape and size similar to intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohda Educational Hospital
Full name of responsible person
Alireza Rouhani
Street address
Golshahr Ave, Shohada Educational Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Sadeghpour
Street address
Shohada Educational Hospital
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tabrizi
Position
MD\Orthopedic resident
Other areas of specialty/work
Street address
Shohada Educational Hospital
City
Tabriz
Postal code
Phone
+98 41 1329 7183
Fax
Email
Tabrizia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Rouhani
Position
Associated professor of orthopedic
Other areas of specialty/work
Street address
Shohada Educational Hospital
City
Tabriz
Postal code
Phone
+98 41 1384 3226
Fax
Email
rouhani.m.d@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Tabrizi
Position
MD/Orthopedic resident
Other areas of specialty/work
Street address
Golasahr Ave, Shohada Educational Hospital
City
Tabriz
Postal code
Phone
+98 41 1329 7183
Fax
Email
Tabrizia@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)