Laser Treatment in Early Wound Healing to Promote Physiological Skin Remodeling
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Clincial evaluation on Patient observer scar assessement scale (POSAS)
研究概览
简要总结
The primary objective of this study is to explore the potential clinical effect of targeting surgical wounds in all three wound healing phases by non ablative fractional laser (NAFL) to reduce scar formation in a randomized controlled trial. Thus, NAFL will be applied during 1) inflammation phase (0-3 days) as represented by NAFL-treatment adjacent to surgical wounding, 2) proliferation phase (4-21 days) by NAFL-treatment immediately after suture removal and 3) remodeling phase (21 days-1 year) by NAFL-treatment six weeks after surgery.
详细描述
This is a prospective, randomized, controlled, assessor - blinded, intra-individual trial comparing laser exposed skin lesions to untreated control skin lesions in a split scar set-up to investigate efficacy. The study will be performed on patients undergoing an excision at Bispebjerg Dermatological Department. One randomly allocated part of each included wound will receive three NAFL-treatments and the other part will serve as untreated control wound. Scars will be evaluated clinically on-site by blinded evaluator immediately before third treatment and 3 months after NAFL-treatments. The clinical data will be supplemented by blinded photo-evaluation, patients' evaluation and non-invasive measurements.
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
- Single (Outcomes Assessor)
盲法说明
the outcome assessor will not know which side is the treated side of scar
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
- •o Subjects referred to excision of either benign, pre malignant or malignant non-melanoma skin cancer (NMSC) lesions.
- •The length of postoperative wound should be estimated to minimum 2.5 cm and may be located on any region of the body
- •Minimum 18 years old
- •Presenting full medical record report at study initiation
- •Fitzpatrick skin type I-III
- •Non-smokers
- •Written informed consent obtained from subject
- •Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation
排除标准
- •o History of or presenting with a keloid scar
- •A subject with a systemic disease not yet stabilized
- •If the patient is pregnant
- •Visible recent sun exposure in test area
- •Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- •Current use of topical treatment and lack of willingness to refrain from future use of topical treatment, such as i.e. silicone products, that potentially can interfere with the test results
- •Unable to follow the outlined study protocol
研究组 & 干预措施
Control
untreated control wound
NAFL-treated wounds
NAFL treated wounds
干预措施: NAFL-treatment (Radiation)
结局指标
主要结局
Clincial evaluation on Patient observer scar assessement scale (POSAS)
时间窗: 3 months followup
validated scar scale
次要结局
- Photoevaluation on visual analogue scale(3 months follow-up)
- Clinical evaluation on Vancouver Scar Scale(1month follow-up and)
- Reflectance measurement(3 months followup)
- Clincial evaluation on Patient observer scar assessement scale (POSAS)(1month follow-up)
研究者
Katrine Elisabeth Karmisholt
MD
Bispebjerg Hospital