A Prospective Observational Clinical Study on Exploring the Value of Surgical Excision Combined With 32P Application in the Treatment of Keloids and the Factors Affecting the Prognosis of Combined Therapy

Обзор

Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens. These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being. 32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas. Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects. For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.

Подробное описание

Keloids are non-cancerous (benign) growths on the skin. They form after an injury, when the skin makes too much connective tissue that thickens and hardens.

These keloids cause big problems for people. They grow uncontrollably on their own, itch, hurt, and look bad. This is especially true if they're on visible areas like the head or neck-they harm both a person's physical comfort and mental well-being.

32P application is a popular treatment for keloids. It's simple, easy to use, quick, and doesn't have many limits on where or when it can be used. Besides keloids, it also works for surface skin issues like hemangiomas.

Here's how 32P works: When it breaks down (decays), it releases beta rays. These rays create a local effect that changes the shape and function of the affected tissue. Blood vessel cells in the area swell, get inflamed, and shrink, eventually blocking the blood vessels. Beta rays also stop two key things from growing too much: fibroblasts (cells that make connective tissue) and new blood vessels. This is how the treatment works-with very low chances of the keloid coming back and few side effects.

For these reasons, we think combining surgery with 32P application is an effective way to treat keloids. Its success rate is similar to, or even better than, surgery combined with low-dose radiation. Also, two factors matter a lot for how well the treatment works long-term: when 32P application is started, and the dose used.

Первичные конечные точки

• Recurrence rate: Defined as the frequency or probability of a patient experiencing a recurrence of symptoms or the condition within 2 years after being clinically deemed cured (Vancouver Scar Scale [VSS] score ≤ 5 points, with a pruritus score of 0). [Срок оценки: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).]

Вторичные конечные точки (2)

• Time to progression (TTP) [Срок оценки: Time Frame: From treatment initiation until first documented progression or study completion (whichever comes first), assessed up to 36 months]
• Patient satisfaction [Срок оценки: At the final follow-up visit, which occurs 36 months after achieving the treatment endpoint (or at study completion if earlier)]

Критерии участия

Критерии включения

• Histological biopsy confirms the patient has keloids. Pathological diagnostic criteria include: 1. Proliferating fibroblasts: A large number of proliferating fibroblasts are usually detected in keloid tissue. 2. Disordered arrangement of collagen fibers: Collagen fibers in normal scars are generally arranged in an orderly manner, while in keloids, they are disorganized and present as thick bundles. 3. Scar tissue extending beyond the original wound boundaries: Keloid tissue often spreads beyond the scope of the initial trauma.
• Patients with keloids ≥3 mm in thickness and within 1 week after surgical excision.
• Patients have at least one measurable lesion as defined by the Vancouver Scar Scale (VSS) criteria.
• Patients have no other skin disorders similar to keloids.
• Patients are capable of understanding and signing the informed consent form.
• Patients are willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow-up appointments, and other study procedures.

Критерии исключения

• Difficulty in accurately assessing the patient's lesions.
• Patients who do not meet the indications for local excision or have received superficial radiotherapy after surgery.
• Dementia, intellectual impairment, or any mental illness that hinders the understanding of the informed consent form.
• Patients deemed inappropriate to participate in this clinical study by the investigator.
• Patients from whom pathological specimens cannot be obtained, or those who die or are lost to follow-up.
• Patients with recurrent keloids following previous treatment.
• Pregnant female patients. -

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07413497 · SYSKY-2025-529-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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