The Comparison of skin grafts harvested from wrist area versus groin area in patients with finger tip injury referring to Imam Reza Hospital during the year 2014 to 2015
In this study we compare wrist and groin harvested finger tip skin grafts to find out which site suits best finger tip skin defects.Seventy two patients in need of finger tip skin grafting aged twenty to seventy years old with no neuropathic disorders are randomized to a 36-patient group with skin graft harvested from the wrist or another 36-patient group with skin graft harvested from the groin. All the patients will be operated by one technique (full-thickness skin garft). The minimum follow up would be eighteen months.The intervention in this study would be skin grafting from two different sites, wrist area and groin area. The grafted skin between the two groups will be evaluated clinically regarding two point discrimination (T.P.D) with Dellon-McKinnon Disk-Criminator, light touch with Semmes-Weinstein monofilaments aesthesiometer , ulcer, graft contracture, hair growth on the grafted skin, and color difference between the graft and recipient site with Photoshop Analayzer Program. The significancy of mean differences in both groups will be compared statistically
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110413259N1
Registration date:2014-12-01, 1393/09/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-01, 1393/09/10
Registrant information
Name
Farzam Mokarami
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8350
Email address
farzam_m2001@yahoo.com
Recruitment status
Recruitment complete
Funding source
Artesh University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of skin grafts harvested from wrist area versus groin area in patients with finger tip injury referring to Imam Reza Hospital during the year 2014 to 2015
Public title
evaluation of skin grafts harvested from wrist area versus groin area
Purpose
Treatment
Inclusion/Exclusion criteria
-The inclusion criteria: normal sensation and judgment, and age between twenty and seventy years old.
-The exclusion criteria: patients with neuropathic disorders including diabetes, autoimmune diseases (eg; sclerodermia), congestive heart failure, chronic liver diseases, chronic renal failure, peripheral vascular diseases and smokers
Age
From 20 years old to 70 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The patients will be randomized to a Wrist group or Groin group with a number allocated by Research Randomizer Program.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Palestine St., Zand Blvd.
City
Shiraz
Postal code
14336-71348
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
ct.p.91.2611
Health conditions studied
1
Description of health condition studied
Injuries to the wrist and hand
ICD-10 code
S60, S61,
ICD-10 code description
Superficial injury of wrist and hand, Open wound of wrist and hand , Crushing injury of wrist and hand , Other and unspecified injuries of wrist and hand
Primary outcomes
1
Description
Skin Color
Timepoint
Before surgery and at least six months afterwards
Method of measurement
Brightness of the skin will be measured by PhotoShop software after taking photos of the grafted area and data will be collected in a questionnaire
2
Description
Contracture
Timepoint
Before surgery and at least six months afterwards
Method of measurement
The proportion of the grafted area to the area of the primary injury will be calculated and data will be collected in a questionnaire
3
Description
Light Touch
Timepoint
Before surgery and at least six months afterwards
Method of measurement
Semmes-Weinstein monofilaments aesthesiometer with different thicknesses data will be collected in a questionnaire
4
Description
Hair Follicle Counts
Timepoint
Before surgery and at least six months afterwards
Method of measurement
The counts of hair follicles in the grafted area and data will be collected in a questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Skin grafts from wrist area (group1): We harvested the adjusted skin graft from the wrist area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days.
Category
Treatment - Surgery
2
Description
Skin grafts from groin area (group2): We harvested the adjusted skin graft from the groin area in elliptical form to incorporate to the size of the loss region in finger tips and tried to remove the subcutaneous fat completely to increase the odds of successful grafting. No meshing procedure were used, Grafts were fixed with absorbable 4.0 (Vicryl, Ethicon Inc, New Jersey) running sutures. Then dressing was applied on by 4-layered sterile gauze in a moderately tight fashion. and due to the low risk of hematoma formation the grafts were seen after 5-7days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazee Hospital
Full name of responsible person
Dr. Behdad Eskandari
Street address
Nemazee Square
City
Shiraz
2
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Farzam Mokarami
Street address
Etemadzade St., West Fatemi St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Palestine St., Zand Blvd.
City
Shiraz
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, Shiraz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice chancellor for research, Artesh University of Medical Sciences
Full name of responsible person
Dr. Kamran Azma
Street address
Etemad Zadeh St., West Fatemi St.
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, Artesh University of Medical Sciences
Proportion provided by this source
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
Artesh University of Medical Sciences
Full name of responsible person
Farzam Mokarami
Position
Orthopaedic Surgery, Medical Doctor
Other areas of specialty/work
Street address
Etemad Zadeh St., West Fatemi St.
City
Tehran
Postal code
Phone
00
Fax
Email
Farzam_m2001@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Reza Sharifzadeh
Position
Orthopaedic surgery, Medical Doctor
Other areas of specialty/work
Street address
Etemad Zadeh St., West Fatemi St.
City
Tehran
Postal code
Phone
00
Fax
Email
Reza.sharifzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Farzam Mokarami
Position
Orthopaedic Surgery, Medical Doctor
Other areas of specialty/work
Street address
Etemad Zadeh St., West Fatemi St.
City
Tehran
Postal code
Phone
00
Fax
Email
Farzam_m2001@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)