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A Clinical Study on the Safety and Efficacy of Wide-Band Ultrasound Combined With Traditional Chinese Medicine Preparations in the Prevention and Treatment of Keloids

Fujian Medical University Union Hospital · 2026
ClinicalTrials.gov · Datasets · License: Public Domain · 2026
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traditional-chinese-medicine
The prevention and treatment of patients with multiple keloids throughout the body are extremely challenging. Keloids are highly resistant, refractory, and prone to recurrence, and are thus known as the "cancer that does not kill". At present, the main clinical strategy for such patients is staged surgical resection, followed by adjuvant local radiotherapy. When signs of recurrence appear, local injection of triamcinolone acetonide plus 5-fluorouracil (5-Fu) is administered as supplementary treatment. However, these two combination therapies have obvious limitations. Adjuvant postoperative radiotherapy is associated with a high incidence of local skin adverse reactions, including radiodermatitis and delayed wound healing. Late complications may occur weeks or months after treatment, such as permanent hyperpigmentation and hypopigmentation, skin atrophy, fibrosis, scabbing and desquamation, and intractable ulcers. In addition, radiotherapy is not suitable for some young female patients and children when keloids are located near organs such as the thyroid gland and gonads. Injection of triamcinolone acetonide plus 5-Fu causes significant pain and requires repeated sessions. Potential risks include local ulceration, hyperpigmentation, telangiectasia, and menstrual irregularities in female patients. Therefore, there is an urgent clinical need for a pathological scar prevention and treatment technique that can rapidly relieve discomfort, promote scar atrophy, cause no secondary injury, carry low risks, have a short recovery period, provide high comfort during treatment, and be applicable to large-area or multiple pathological scars across the body. Our research team previously observed in clinical practice that wide-band ultrasound (Universal Beauty® Type I Ultrasound Therapeutic Device) combined with traditional Chinese medicine (TCM) preparations can release abnormally accumulated and contracted collagen fibers in scar tissue via ultrasonic energy. Meanwhile, ultras
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