The objective of this nonrandomized,trial study is to investigate the efficacy of crossed needle thechniqe on surgical removal of neglected soft tissue foreign bodies. In this study, forty-one neglected soft tissue foreign bodies were selected in fifteen patientes. Successful surgical removal of soft tissue foreign bodies was assessed. Pre operative neurologic and functional assessments were performed. The cosmetic result and any complications such as neurologic and/or functional impairement were assessed in the follow up period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201141906N2
Registration date:2012-05-07, 1391/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-07, 1391/02/18
Registrant information
Name
Ali Ebrahimi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 3862
Email address
aebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2006-03-10, 1384/12/19
Expected recruitment end date
2010-08-14, 1389/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical Removal of Neglected Soft Tissue Foreign Bodies by Needle Guided Technique
Public title
Surgical Removal of Neglected Soft Tissue Foreign Bodies by Needle Guided Technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all soft tissue foreign bodies which were detected by physical examination and foreign bodies without any sign and symptom of neurologic and functional impairment.
Exclusion criteria: deep embeded foreign bodies which did not detected by physical examination and foreign bodies with neurologic and/or functional impairment and foreign bodies which were located in high risk areas.
Age
From 10 years old to 54 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Number 2bulding, Kermanshah University of Medical Sciences, Shahid beheshti blvd
City
Kermanshah
Postal code
Approval date
2006-02-07, 1384/11/18
Ethics committee reference number
پ/84/96
Health conditions studied
1
Description of health condition studied
Surgical removal of neglected soft tissue foreign body
ICD-10 code
M79.5
ICD-10 code description
Residual foreign body in soft tissue
Primary outcomes
1
Description
Surgica removal of foreign body
Timepoint
End of operation
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Neurologic and functiona assessment of operation site.cosmetic result of surgical site
Timepoint
End of operation,the end of first and second post operative weeks,the end of third and sixth post operative months
Method of measurement
Clinical observation
Intervention groups
1
Description
surgcal incision by needle guided techniqu for removal of neglected soft tissue foreign body/ treatment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Street address
Haj daii clinic of dermatology, Golestane sq
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Number 2 bulding, Kermanshah University of Medical Sciences, Shahid beheshti blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Position
Dermatologist/ faculty member
Other areas of specialty/work
Street address
Haj daii clinic of dermatology, Golestane sq
City
Kermanshah
Postal code
Phone
+98 83 1823 3862
Fax
Email
aebrahimi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Position
Dermatologist/ faculty member
Other areas of specialty/work
Street address
Haj daii clinic of dermatology, Golestane sq
City
Kermanshah
Postal code
Phone
+98 83 1823 3862
Fax
Email
aebrahimi@kums.ac .ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Position
Dermatologist/ faculty member
Other areas of specialty/work
Street address
Haj daii clinic of dermatology, Golestane sq
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)