NCT04472715已完成不适用
EVALUATION OF THE EFFICACY OF FOLLICULAR UNIT EXTRACTION VERSUS FOLLICULAR UNIT EXTRACTION WITH PLATELETS RICH PLASMA IN TREATMENT OF CICATRICAL ALOPECIA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- hair regrowth
研究概览
简要总结
follicular unit extraction as a method of hair transplantation in cicatricial alopecia
详细描述
The study will include 20 patients with cicatrical alopecia.Patients will be randomly assigned into two groups:Group (A):include ten patients will undergo (FUE) alone.
Group (B): include ten patients will undergo(FUE) and (PRP).3-Surgical technique:
- Preoperative Investigations including complete blood count, coagulation profile and hepatitis viral markers.
1-Group(A): will undergo (FUE)
- Washing the scalp with antiseptic shampoo before the procedure.
- Tumuscentanaesthesia:The donor area is anesthetized with a lidocaine 1% solution diluted with 20 cc saline in addition to adrenaline.
- Creation of micropunches(0.7-1 mm) using micromotor.
- After removal of the punch,the follicular unit is extracted with Jweler's forceps.
- Extracted grafts are then placed on chilled saline gauze for maximum four hours until ready for transplantation.
- The recipient area is prepared with rectangular scalpel blades 1mm or hypodermic blades 0.9 mm.
- Implantation using fine tipped jweler's forceps.
- Finally, receptor and donor areas will be softly cleansed with saline and crepe bandage is applied.
2-Group (B): FUE+PRP
- The same procedure will be done but grafts will be placed in Prp solution.
- Prp session one week before transplantation then monthly for 3 monthes after (FUE).
- Preparation of PRP
- 10 cc blood will be aspirated in test tube contained a modified solution of anticoagulant,called acid-citrate-dextrose type (ACDA), in which the physiological pH will reached to preserve the platelet integrity.
- The first spin of whole blood sample will be at 2500 rpm for 4 minutes
- The second spin at 4000 for 20 minutes for obtained plasma.
- Platelets are separated as a pellet at the bottom of the tube from platelet-poor plasma (PPP) above. The platelet-rich pellet is resuspended in remaining amount of plasma. The resulting suspension is used as PRP.
- Prp is injected in the recipient area. 4-Follow up:
- Follow up clinically by digital photographs and trichoscopy 1 week after operation, after 3 months and after 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with unacceptable visible scarring alopecia.
- •Adequate donor area.
- •patient free of signs of disease activity evidenced by trichoscopy.
- •Patients having inadequate laxity for a strip excision (too tight skin).
- •When previous scars of strip surgeries make further strips impossible.
排除标准
- •• Inadequate donor area.
- •Signs of active disease or infection.
- •Patient who is not willing for long sessions for several hours or multiple sessions as needed due to the slowness of the process
- •Contraindications for surgical procedure as bleeding tendency.
- •Contraindications for PRP as (cardiovascular, autoimmune disorders, hematological disorders and neoplasms).
结局指标
主要结局
hair regrowth
时间窗: 6 months
transplanted hair develop int new hair growth in bald area
次要结局
未报告次要终点
研究者
marwa eldeeb
Lecturer of dermatology
Alexandria University
研究点 (2)
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