- Aim of the study: comparison of nail bed repair with and without using nail plate in improving cosmetics and functional aspects
-Main inclusion criterion: nail bed rupture
-Main exclusion criterion: former deformity and nail bed rupture history in finger;
-Population being studied: patients with nail bed rupture
-The volume of the sample: 60
-Duration of intervention: 8 months
-Primary outcome measures: pain scale using Visual Analogue Scale(VAS), rate of infections, functional and cosmetics state
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111119901N1
Registration date:2014-11-25, 1393/09/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-25, 1393/09/04
Registrant information
Name
Hosein Ahmadzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 9314
Email address
dr.amir87@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-21, 1391/06/31
Expected recruitment end date
2013-04-19, 1392/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comprarison of effectiveness of using and not using nail plate from the point of infection and cosmetic aspects in patients with nail bed injuries
Public title
comprarison of nail bed repair with and without nail plate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: nail bed rupture
Exclusion criteria: former deformity history in finger; former history of nail bed rupture; presence of a defect in distal phalanx; fracture of the dital phalanx,that requires fixation
Age
No age limit
Gender
Both
Phase
N/A
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research council of Ethics Committe of Tabriz University of Medical Sciences
Street address
third floor,central building number 2,Tabriz university of medical sciences,Golgasht street
City
Tabriz
Postal code
5167846171
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
9396
Health conditions studied
1
Description of health condition studied
Nail bed rupture
ICD-10 code
s61.1
ICD-10 code description
open wound of fingers with damage to nail
Primary outcomes
1
Description
Pain scale based on Visual Analogue Scale(VAS)
Timepoint
First, second and third weeks,and second and third months after intervention
Method of measurement
Based on patient's statements, subjectively
2
Description
Infections
Timepoint
First, second and third weeks,and second and third months after intervention
Method of measurement
infectious drainage and erythma
3
Description
functional state
Timepoint
First, second and third weeks,and second and third months after intervention
Method of measurement
restoring function and normal interphalangeal joints of finger range of motion
4
Description
Comsetic aspects
Timepoint
First, second and third weeks,and second and third months after intervention
Method of measurement
preserving nail bed shape, without any deformities
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: nail bed repair with nail plate,without any fractures that need fixation
Category
Treatment - Surgery
2
Description
Control group: Nail bed repair without using nail plate
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Asghar Elmi
Street address
Shohada hospital, Golshahr street, Elgoli road
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Saeid Aslanabadi
Street address
Orthopedics educational group, Shohada hospital, Golshahr street, El Goli broadway
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 of 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
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
5167846171
Phone
+98 41338593147
Fax
Email
elmimail@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
5167846171
Phone
+98 41338593147
Fax
Email
elmia@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asghar Elmi
Position
Orthopedician
Other areas of specialty/work
Street address
Orthopedics educational group, Shohada hospital, Golshahr street, El Goli broadway
City
Tabriz
Postal code
5167846171
Phone
+98 41 3385 9314
Fax
Email
elmimail@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)