A comparative study on cosmetic outcomes and hair follicular density of the surgical site incision in standard reverse question mark incision and L.G Kemp incision in patients undergoing Frontotemporoparietal craniotomy Surgery
Determining the effect of two methods of scalp incision L.G Kempe and Reverse question mark in terms of aesthetic effect and on the density of follicles on the inised area in patients undergoing Frontotemporoparietal Decompressive surgery.
Design
Patients who are candidates for frontotemporaneopranital craniotomy surgery are randomly divided into two groups by permutation block method. Biopsy of the sites to be taken and aesthetic evaluation is performed using SBSES and direct questioning from the patient. The results will be compared with the previous sample of the patient in the two groups.
Settings and conduct
Patients who are candidates for frontotemporaneopranital craniotomy surgery are randomly divided into two groups by permutation block method. Biopsy of the sites to be taken and aesthetic evaluation is performed using SBSES and direct questioning from the patient. The results will be compared with the previous sample of the patient in the two groups.
Participants/Inclusion and exclusion criteria
People between the ages of 18-65 who do not have an underlying disorders affecting follicular hair growth
Intervention groups
group 1: patients undergoing reverse question mark( standard) frontotemporoparietal craniotomy
group 2: patients undergoing LG-Kemp frontotemporoparietal craniotomy
Main outcome variables
LG kempe group hair follicular density, standard group hair follicular density, SBSES score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180906040962N1
Registration date:2020-10-06, 1399/07/15
Registration timing:retrospective
Last update:2020-10-06, 1399/07/15
Update count:0
Registration date
2020-10-06, 1399/07/15
Registrant information
Name
Behnia Ahmadi Halili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3225 5339
Email address
behnia.1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on cosmetic outcomes and hair follicular density of the surgical site incision in standard reverse question mark incision and L.G Kemp incision in patients undergoing Frontotemporoparietal craniotomy Surgery
Public title
A comparative study on cosmetic outcomes and hair follicular density of the surgical site incision in standard reverse question mark incision and L.G Kemp incision in patients undergoing Frontotemporoparietal craniotomy Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidates for frontotemporoparietal or lg kep craniotomy
age 18-65
Exclusion criteria:
traumatic scar wor wound in the craniotomy site
history of radiation therapy
diabetes mellitus
vascular diseases
dermatologic diseases ( e.g psoriasis, alpoecia, etc.)
use of immunosuppressive drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
2
salp biopsy
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups by permutation block method. In this way, patients will be randomly divided into a group of 40 blocks, which includes two groups in equal numbers and in the same time sequence, into a group of 20 people and a group of 20 controls.
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
ethics comittee of Ahaz Jundishapour university of medical scienecs
Street address
Golestan Blvd, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6174758965
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
ir.ajums.hgolestan.rec.1399.004
Health conditions studied
1
Description of health condition studied
craniotomy
ICD-10 code
S06.2X
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
follicular density of the scalp
Timepoint
6 months
Method of measurement
mean number per HPF
Secondary outcomes
1
Description
aesthetics evaluation
Timepoint
6 months
Method of measurement
Stony Brook Scar Evaluation Scale(SBSES), and direct question from the patient
Intervention groups
1
Description
Patients undergoing LG Kemp incision craniotomy. Before the operation, a skin biopsy will be taken from the incision area in the area described in the procedure. Six months later, another biopsy is taken from the affected area and compared with the preoperative sample for follicular density. Wound scars will also be assessed by the SBSES scoring system.
Category
Treatment - Surgery
2
Description
Control group: Patients undergoing standard reverse question mark incision craniotomy. Before the operation, a skin biopsy will be taken from the incision area in the area described in the procedure. Six months later, another biopsy is taken from the affected area and compared with the preoperative sample for follicular density. Wound scars will also be assessed by the SBSES scoring system.