Comparing Recipient Site Preparation Using Dermabrasion, Dermaroller and Liquid Nitrogen Induced Blister in Non Cultured Epidermal Cell Suspension in Stable Vitiligo
NCT03668834 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2018-09-13
Summary
A COMPARATIVE STUDY BETWEEN RECEPIENT SITE PREPARATION USING DERMABRASION, LIQUID NITROGEN INDUCED BLISTER AND DERMAROLLING SYSTEM IN AUTOLOGOUS NON CULTURED EPIDERMAL CELL SUSPENSION PROCEDURE IN STABLE VITILIGO PATIENTS
Conditions
- Vitiligo
Interventions
- PROCEDURE
-
Dermabrasion with NCES
1. The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1). 2. Dermabrasion will be done using Manekshaw's dermabrader until tiny pinpoint bleeding spots are seen and extended 5mm beyond margins to prevent halo phenomenon. 3. The denuded area will be washed with PBS and covered with a PBS moistened gauze piece. 4. With 18 G needle attached to tuberculine syringe, few small drops of non cultured epidermal cell suspension will be placed over the denuded surface and spread evenly. 5. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
- PROCEDURE
-
Dermaroller with NCES
1. The recipient site will be shaved, cleaned with betadine and surgical spirit. 2. Microneedling will be done with a device containing 540 microneedles in 8 rows, each 0.25 mm in length. Microneedling will be extended 5 mm beyond margins to prevent halo phenomenon. 3. The roller will be passed repeatedly over the skin in a star-shaped way for about 10 minutes 4. The noncultured epidermal cell suspension will be carefully transferred to a tuberculin syringe. 5. NCES will be applied to the skin surface with a tuberculin syringe with an 18G needle and spread evenly after dermarolling treatment. 6. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
- PROCEDURE
-
Liquid nitrogen induced blister with NCES
1. The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1). 2. The site to be grafted is outlined with a surgical marking pen. 3. To induce blisters on the achromic areas, freezing with liquid nitrogen spray was performed during 10 to 20 seconds inside round circles previously drawn on the skin. 4. The patient is asked to visit 24 hours later. 5. The blister fluid is aspirated and NCES taken in tuberculin syringe with 18 G needle is injected into it such that the blister roof is preserved. 6. Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster).
Sponsors & Collaborators
-
Post Graduate Institute of Medical Education and Research, Chandigarh
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-01
- Primary Completion
- 2019-06-30
- Completion
- 2019-06-30
Countries
- India
Study Locations
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