A Comparative Study Between Recipient Site Preparation Using Dermabrasion,Liquid Nitrogen Induced Blister and Dermarolling System in Autologous Non Cultured Epidermal Cell Suspension Procedure in Stable Vitiligo Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Comparison of extent of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non culured epidermal cell suspension.
研究概览
简要总结
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
详细描述
With a sample size of 36, 3 patches of a single stable vitiligo patient will be prepared using dermabrasion,dermaroller system and liquid nitrogen induced blister. The autologous non cultured epidermal cell suspension will be prepared using cold trypsinization from the skin graft taken from patient.After preparation of the recipient site,the suspension is applied and dressing is done.The patient is followed up for 3 months and extent of repigmentation,colour match,pattern of repigmentation,patient satisfaction score, vitiligo quality of life index before and after surgery and effect on acral vs non acral regions are studied for all the 3 methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of generalized vitiligo
- •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.
排除标准
- •Age less than 18 years
- •Pregnancy and lactation
- •Patient with actively spreading vitiligo
- •History of Koebnerisation
- •History of hypertrophic scars or keloidal tendency
- •Bleeding disorders
- •Patients with unrealistic expectation
研究组 & 干预措施
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.
干预措施: Dermabrasion with NCES (Procedure)
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.
干预措施: Dermaroller with NCES (Procedure)
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.
干预措施: Liquid nitrogen induced blister with NCES (Procedure)
结局指标
主要结局
Comparison of extent of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non culured epidermal cell suspension.
时间窗: 3 months from the surgery
The extent of repigmentation is done by measurement of lesions in a tracer paper before and after surgery and comparison of pre operative and post operative images clicked in Canon Powershot SX620HS 20.2MP camera and grading is done as ≤25% Minimal repigmentation 26-50% Mild repigmentation 51-75% Moderate repigmentation 76-90% Marked repigmentation \>90% Excellent repigmentation
次要结局
- Comparison of colour match of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non culured epidermal cell suspension.(3 months from the surgery)
- Comparison of pattern of repigmentation in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension.(3 months from the surgery)
- Comparison of adverse events in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension.(3 months from the surgery)
- Comparison of repigmentation in acral vs non acral areas in the vitiligo patches following dermabrasion, dermaroller system and liquid nitrogen induced blister followed by autologous non cultured epidermal cell suspension.(3 months from the surgery)
- Patient satisfaction index(3 months from the surgery)
- Vitiligo quality of life index.(3 months from the surgery)
研究者
Davinder Parsad
Dr.Davinder Parsad
Post Graduate Institute of Medical Education and Research, Chandigarh