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Not Yet RecruitingNCT07413497

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
401 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2026-06-01
Primary completion
2029-06-01
Completion
2030-06-01
First posted
2026-02-17
Last updated
2026-02-17

Source: ClinicalTrials.gov record NCT07413497. Inclusion in this directory is not an endorsement.

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