Comparison of the results of partial thickness skin graft of the scalp with partial thickness skin graft of the leg for the treatment of scalp skin defects
Design
A randomized controlled study, with 40 patients between January 2018 and March 2019 and followed for three months
Settings and conduct
Study place: plastic surgery ward of Besat Hospital in Hamedan. The partial thickness skin graft from healthy scalp areas adjacent to the scalp defect. The middle thickness (inch 0.04) skin tissue is prepared with D80 or D42 electric dermatome or manual dermatome. The donor area is covered by a layer of gas, and then a layer of dry gas. The skin graft is covered in the recipient region follows the principles of plastic surgery with tie-over dressing. Some complications and outcomes such as pain, graft take, total epithelialization time, patient satisfaction in terms of cosmetic and scar removal induced by the graft in healthy and distant areas of the limbs, folliculitis, scab formation, and alopecia are evaluating in determined dates after the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients of any age and gender with scalp defect requiring the skin graft repair primarily for existing defect or secondary to repair the defect resulting from rotation of flap in the scalp. Exclusion criteria: patient dissatisfaction, scarring or skin diseases such as eczema, folliculitis, tumoral or precancerous lesions, such as keratosis, scaring scalps due to severe scalp burns or atrophy, or radiation
Intervention groups
Intervention group: patients with scalp skin defects with various etiologies that scalp skin graft is used for them. Control group: twenty patients with scalp defects treated with routine and commonly used skin grafts (leg skin graft).
Main outcome variables
Graft take; patient pain after grafting; patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031928N2
Registration date:2018-08-16, 1397/05/25
Registration timing:registered_while_recruiting
Last update:2018-08-16, 1397/05/25
Update count:0
Registration date
2018-08-16, 1397/05/25
Registrant information
Name
Mehrdad Taghipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3262 4331
Email address
m.taghipour@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Outcome of Partial Thickness Skin Graft Harvesting from Scalp with the Calf for Scalp Skin Defects
Public title
Evaluating the effects of Partial Thickness Skin Graft Harvesting from Scalp for Scalp Skin Defects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients of any age and gender with scalp defect requiring repair of the skin graft primarily for the present defect or secondary to the defect in order to repair the defect result from flap rotation in the scalp.
Exclusion criteria:
Patient dissatisfaction, scarring or skin disease that prevents skin graft from the scalp, such as eczema, folliculitis, tumor or pre-cancerous lesions such as keratosis, scalp scar due to severe scalp burn or severe atrophy, or radiation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients of all ages and sexes were randomly assigned into two groups of 20 patients and 20 patients receiving routine treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shahid Beheshti Blvd, Besat Hospital
City
Hamedan
Province
Hamadan
Postal code
48138
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.UMSHA.REC.1397.224
Health conditions studied
1
Description of health condition studied
Scalp skin defect
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head, face, and neck
2
Description of health condition studied
Scalp skin defect
ICD-10 code
C43.4
ICD-10 code description
Malignant melanoma of scalp and neck
3
Description of health condition studied
Scalp skin defect
ICD-10 code
D23.4
ICD-10 code description
Other benign neoplasm of skin of scalp and neck
4
Description of health condition studied
Scalp skin defect
ICD-10 code
S08
ICD-10 code description
Avulsion and traumatic amputation of part of head
5
Description of health condition studied
Scalp skin defect
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score in VAS index
Timepoint
measuring of the pain based on VAS score during the days 5, 16,35 and 90
Method of measurement
VAS score checklist
2
Description
Graft take based on Likert index
Timepoint
graft take during the days 5,16,35 and 90
Method of measurement
Likert score checklist
Secondary outcomes
1
Description
Patient Satisfaction
Timepoint
At the end of the study
Method of measurement
Likert index
Intervention groups
1
Description
Intervention group: Partial thickness skin graft from healthy areas of the adjacent scalp and scalp defect/ electric dermatome D80 or D42 or manual dermatome for the preparation of middle-thickness skin grafts (0.04 inch ) / Marking the skin of scalp in Temporal, parietal or occipital areas with methylene blue / the designed area swells with infusion of some normal saline solution/defects up to 50% of the scalp can be reconstituted with 50% of the rest of the skull's healthy skin. The donor area is covered by a gas and jelly layer followed by a dry gaseous layer/ the graft in the receptor is covered in accordance with the principles of plastic surgery with "tie-over dressing" and then the entire scalp including the receiver and donor area is enclosed with Sergi Fix.
Category
Treatment - Surgery
2
Description
Control group: Twenty-one patients with scalp defects that are treated with the routine and commonly used skin graft (leg skin graft) are selected as a control group.
Hamadan, Shariati Ave, Shahid fahmideh blvd, vice-chancellor for research and technology
City
Hamadan
Province
Hamadan
Postal code
48136
Phone
+98 81 3838 0717
Email
s.bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehrdad Taghipour
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Khaje Rashid Crossroads - Ayatollah Kashani Blvd.
City
Hamedan
Province
Hamadan
Postal code
48138
Phone
+98 81 3262 4331
Fax
+98 81 3262 4331
Email
m.taghipour@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahdi Eskandarlou
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic surgery
Street address
Besat hospital, Shahid beheshti blvd.
City
Hamadan
Province
Hamadan
Postal code
48137
Phone
+98 81 3264 0030
Email
Dr.eskandarlou@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehrdad Taghipour
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Blvd, Besat hospital
City
Hamadan
Province
Hamadan
Postal code
48138
Phone
+98 81 3264 0030
Email
m.taghipour@edu.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All results from the analysis of the preliminary data of the study and the resulting article will be shared.
When the data will become available and for how long
Access to the data will be possible immediately after the final paper is printed.
To whom data/document is available
All authors, researchers, and clinical experts will have access to the data of this study.
Under which criteria data/document could be used
A broad analysis of data of this study will be welcomed along with data from other studies for writing meta-analytic review articles.
From where data/document is obtainable
For more information, please contact Dr. Mehrdad Taghipour on 09128407085. All correspondence with e-mail: m.taghipour@edu.umsha.ac.ir will be accepted.
What processes are involved for a request to access data/document
After making a phone call and submitting an application in the mail, the final reply will be sent at least one month.