Comparing Recipient Site Preparation Using Dermabrasion, Dermaroller and Liquid Nitrogen Induced Blister in Non Cultured Epidermal Cell Suspension in Stable Vitiligo
NCT ID: NCT03668834
Last Updated: 2018-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2018-01-01
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dermabrasion with NCES
Intervention-Dermabrasion with autologous non cultured epidermal cell suspension Recipient site preparation using dermabrasion followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
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).
Dermaroller with NCES
Intervention-Dermaroller with autologous non cultured epidermal cell suspension Recipient site preparation using dermaroller system followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
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).
Liquid nitrogen induced blister with NCES
Liquid nitrogen induced blister with autologous non cultured epidermal cell suspension Recipient site preparation using liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension technique of 1 stable vitiligo patch of each of the 36 patients.
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).
Interventions
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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).
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).
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).
Eligibility Criteria
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Inclusion Criteria
* Patients with symmetrical lesions of size \> 1.5cm x 1cm present on trunk or extremities including acral areas.
* Vitiligo lesions has been stable for 1 year.
* Disease not responding to medical treatment, or there are residual patches (after medical therapy) of vitiligo .
* Maximum size of vitiligo patches to be selected for surgery will not be \>100cm2.
Exclusion Criteria
* Pregnancy and lactation
* Patient with actively spreading vitiligo
* History of Koebnerisation
* History of hypertrophic scars or keloidal tendency
* Bleeding disorders
* Patients with unrealistic expectation
18 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Davinder Parsad
Dr.Davinder Parsad
Locations
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PGIMER
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INT/TEC/2018/000424
Identifier Type: -
Identifier Source: org_study_id
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