A Study of the Efficacy and Safety of Non-ablative Fractional Laser in the Treatment of Thyroidectomy Scars
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The depth of scar echoes
研究概览
简要总结
The subject's neck thyroidectomy incision was bisected along the anterior midline. One side received 1565 nm non-ablative fractional laser treatment, designated as the study side, according to a computer-generated randomization scheme, while the other side received a sham treatment (the laser device emitted sound only, without delivering any energy), serving as the control side. Outcome indicators were recorded during follow-up, along with any related adverse events and/or reactions occurring during and after the treatment. The aim was to evaluate the effectiveness and safety of the 1565 nm non-ablative fractional laser in the treatment of postoperative thyroid scars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is conscious, with no intellectual disability or cognitive difficulties, and understands and signs the informed consent form.
- •Healthy male and female subjects aged 18 to 70 years.
- •Fitzpatrick skin types I to V.
- •Women of childbearing age have used contraceptive measures within three months before enrollment.
- •The patient has undergone traditional thyroidectomy through the anterior neck approach within 15 days, with a surgical incision visible in the midline of the neck, symmetric along the anterior midline of the body surface; or the patient has undergone traditional thyroidectomy through the anterior neck approach within one year, with a linear hypertrophic surgical scar visible in the midline of the neck, symmetric along the anterior midline of the body surface.
- •The patient is able to comply with all the plans and requirements for visits, treatments, and assessments.requirements.
排除标准
- •Need for modified radical neck dissection or reoperation, or other surgical plans that may affect treatment and follow-up during the trial period;
- •Previous neck surgery;
- •Pregnant, planning to become pregnant during the study period, less than three months postpartum, or less than six weeks after completing breastfeeding;
- •History of keloid or delayed wound healing;
- •Uncontrolled systemic diseases;
- •History of mental disorders;
- •Presence of skin tumors or skin inflammation in the treatment area;
- •Active infection in the neck area or systemic infection;
- •Use of oral photosensitizing drugs or retinoids within six months before screening;
- •Use of anticoagulants, corticosteroids, immunosuppressants, or other drug treatments within three months before screening;
- •Exposure to strong ultraviolet radiation causing desquamation, erythema, or other conditions in the neck within one month before screening;
- •Participation in other drug/medical device clinical trials within one month before screening or planned participation during the study period;
- •Use of any other treatment methods for post-thyroidectomy scars except for silicone gel sheets and topical drugs before and during treatment;
- •Use of silicone gel sheets and topical drugs for post-thyroidectomy scars within seven days before starting treatment;
- •Patients allergic to compound lidocaine cream or its components, and no alternative to this drug is available;
- •Patients who, in the investigator's opinion, have other conditions that may affect compliance or are not suitable for participating in this study.
结局指标
主要结局
The depth of scar echoes
时间窗: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
Using the high-frequency skin ultrasound MD-300SⅡ, multiple-point measurements were taken in five different areas on both sides of the scar to determine the maximum and minimum values of scar echo depth and to calculate the average value of the five measurement points.The unit of measurement is millimeters.
The width of scar echoes
时间窗: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
Using the high-frequency skin ultrasound MD-300SⅡ, multiple-point measurements were taken in five different areas on both sides of the scar to determine the maximum and minimum values of scar echo width and to calculate the average value of the five measurement points.The unit of measurement is millimeters.
Intensity of scar echoes
时间窗: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
Using image processing software (Adobe Photoshop) to process the ultrasound images, the magic wand tool was used to select three areas of the same size on the scar. The average grayscale value of each area was read using the histogram function, and the average value of the five measurement points was calculated. The grayscale value is proportional to the echo intensity.
Modified vancouver scar scale score
时间窗: Baseline,1month,2month,3month,4month,5month,8month,11month,17month
The Modified Vancouver Scar Scale has a maximum score of 18 and a minimum score of 0, with higher scores indicating worse outcomes.
次要结局
- Scar color(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Scar area(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Patient and Observer Scar Assessment Scale score(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Manchester Scar Scale score(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Medical Outcomes Study Health Survey Short Form-36 Item score(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Standardized assessment by doctor and patient(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Incidence of adverse events(Baseline,1month,2month,3month,4month,5month,8month,11month,17month)
- Histological evaluation(17month)
研究者
Chengxin Li
Professor.
Chinese PLA General Hospital