跳至主要内容
临床试验/NCT06171386
NCT06171386招募中不适用

Microneedling vs Dermabrasion for Early Facial Scar Resurfacing

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Change in Vancouver Scar Scale Scores

研究概览

简要总结

This study aims to determine whether microneedling or dermabrasion in the early post-operative period is superior in improving the appearance of surgical scars on the face.

详细描述

Microneedling and dermabrasion are two common modalities that may be performed in-office to treat surgical scars.

Microneedling is a form of collagen induction therapy, often used in conjunction with platelet-rich plasma or hyaluronic acid.

Dermabrasion is a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization.

To determine which modality is most effective, a prospective study; randomizing a volunteer sample of adult patients with new surgical vertical forehead scars will receive either dermabrasion or microneedling in the early postoperative period.

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

入选标准

  • Volunteer adult patients will be identified by visiting the Facial Plastics and Reconstructive Surgery Clinic at Atrium Health Wake Forest Baptist.
  • Patients will be 18 years old+ and have a vertical surgical scar in the superior 1/3 of the face (trichion to glabella).
  • Patients will enroll in the clinic research registry and indicate an interest in being involved in the study.

排除标准

  • Patients who rate Types 4-6 on the Fitzpatrick scale will be excluded due to risk of poor outcome from dermabrasion.
  • There are no other planned exclusion criteria. Patients will not be excluded on the basis of gender, race/ethnicity, or age, provided that they meet the described inclusion criteria.

研究组 & 干预措施

microneedling

Active Comparator

microneedling is a form of collagen induction therapy, often used in conjunction with platelet-rich plasma or hyaluronic acid - Patients will receive two treatments, once at 6-8 weeks following facial surgery, and the second at 12-16 weeks following facial surgery

干预措施: Microneedling (Procedure)

dermabrasion

Active Comparator

dermabrasion is a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization - Patients will receive the standard of care treatment 6-10 weeks following facial surgery

干预措施: Dermabrasion (Procedure)

结局指标

主要结局

Change in Vancouver Scar Scale Scores

时间窗: Month 7

Four characteristics of the scar are assessed. These are: vascularity, height, pliability, and pigmentation. Each characteristic is given a score, which are added together to give an overall score between 0 and 13 - lower scores denoting normal skin

Change in Patient and Observer Scar Assessment Scale Scores

时间窗: Month 7

Items and total scale scores for the patient and observer: Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60 - lower scores denoting normal skin

Change in Global Aesthetic Improvement Scale Scores

时间窗: Month 7

5-point scale wherein 2 = much improved (marked improvement in appearance), 1 = improved (improvement in appearance but a touch-up or re-treatment is indicated - lower scores denoting normal skin

次要结局

  • Patient perceived benefit(At time of procedure (pain scale); at 6 months (yes/no))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验