A Study of the Efficacy and Safety of Non-ablative Fractional Laser in the Treatment of Thyroidectomy Scars

Обзор

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.

Вмешательства

• Устройство Non-ablative fractional laser treatment
  The entire scar area is sealed with local anesthetic for 60 minutes before laser treatment. Give the study side 1565 nm non-ablative fractional laser treatment, spot diameter 10～16 mm, energy 40～45 mJ/cm2, spot density 150～200/cm2,1\~2passes.

Первичные конечные точки

• The depth of scar echoes [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• The width of scar echoes [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Intensity of scar echoes [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Modified vancouver scar scale score [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]

Вторичные конечные точки (8)

• Scar color [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Scar area [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Patient and Observer Scar Assessment Scale score [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Manchester Scar Scale score [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Medical Outcomes Study Health Survey Short Form-36 Item score [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Standardized assessment by doctor and patient [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Incidence of adverse events [Срок оценки: Baseline,1month,2month,3month,4month,5month,8month,11month,17month]
• Histological evaluation [Срок оценки: 17month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA Genaral Hosptial — Пекин

Идентификаторы

NCT: NCT07037264 · S2024-594-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗