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

N/ANot Yet RecruitingNCT07413497

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University401 enrolled

Overview

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Patients with keloids ≥3 mm in thickness and within 1 week after surgical excision. 3. Patients have at least one measurable lesion as defined by the Vancouver Scar Scale (VSS) criteria. 4. Patients have no other skin disorders similar to keloids. 5. Patients are capable of understanding and signing the informed consent form. 6. Patients are willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow-up appointments, and other study procedures. Exclusion Criteria: 1. Difficulty in accurately assessing the patient's lesions. 2. Patients who do not meet the indications for local excision or have received superficial radiotherapy after surgery. 3. Dementia, intellectual impairment, or any mental illness that hinders the understanding of the informed consent form. 4. Patients deemed inappropriate to participate in this clinical study by the investigator. 5. Patients from whom pathological specimens cannot be obtained, or those who die or are lost to follow-up. 6. Patients with recurrent keloids following previous treatment. 7. Pregnant female patients. -

Outcomes

Primary Outcomes

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).

Recurrence is determined by an increase in the VSS total score by ≥ 2 points compared to the clinical cure baseline. Enrolled patients will undergo sequential surgical excision followed by ³²P application therapy. The treatment endpoint is defined as either achieving a minimum therapeutic dose of 15Gy with a VSS score ≤ 5 (including a pruritus subscore of 0) or a cumulative total dose of 30Gy. After treatment completion, patients will be followed up every 6 months, and recurrence will be evaluated based on the VSS score at each follow-up visit.

Time frame: From the date of achieving the treatment endpoint until 24 months post-endpoint (assessed every 6 months during follow-up).

Secondary Outcomes

Time to progression (TTP)

Time to progression (TTP): The time from the initiation of treatment to the occurrence of keloid progression (defined as an increase in Vancouver Scar Scale \[VSS\] score by ≥2 points or visible enlargement of the lesion).

Time frame: Time Frame: From treatment initiation until first documented progression or study completion (whichever comes first), assessed up to 36 months

Patient satisfaction

Patient satisfaction with the final therapeutic effect will be evaluated using a validated 5-point Likert Scale, where scores are defined as follows: 1 = Extremely dissatisfied, 2 = Dissatisfied, 3 = Neutral, 4 = Satisfied, 5 = Extremely satisfied. Assessment will be conducted by trained investigators through face-to-face interviews or standardized questionnaires at the final follow-up visit.

Time frame: At the final follow-up visit, which occurs 36 months after achieving the treatment endpoint (or at study completion if earlier)