A Study of the Efficacy and Safety of Non-ablative Fractional Laser in the Treatment of Thyroidec… (NCT07037264) | Clinical Trial Compass
By InvitationNot Applicable
A Study of the Efficacy and Safety of Non-ablative Fractional Laser in the Treatment of Thyroidectomy Scars
China120 participantsStarted 2024-09-01
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Need for modified radical neck dissection or reoperation, or other surgical plans that may affect treatment and follow-up during the trial period;
✕. 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;