Keloid
Conditions
Interventions
Blank Control Group (0# Group):None (used as control)
Ultrasound + Chinese Medicine Group (1# Group):Broadband ultrasound combined with Chinese medicine preparation (Chuangli Fu): treatment frequency every 3 days, 10 sessions total (first phase)
second phase starts 1 week after suture removal, once per week, 12 sessions total.
Ultrasound + Normal Saline Group (2# Group):Broadband ultrasound combined with normal saline gauze dressing: treatment frequency every 3 days, 10 sessions total (first phase)
Chinese Medicine Gauze Dressing Only Group (3# Group):Only apply gauze soaked in Chinese medicine preparation to the keloid lesion for 30 minutes (wrap surface with cling film to enhance penetration a
10 sessions total (first phase)
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Have two or more keloids distributed across the body; candidates must opt for surgical excision and repair. The minimum distance between the two surgical lesions shall be over 1 cm, and the lesions shall be located in the same type of anatomical region (e.g., abdomen/chest/upper extremities/lower legs, etc.). 2. Aged 14 to 60 years old. 3. The target keloids have shown no significant spontaneous regression or continued enlargement in the past 3–6 months, or are accompanied by obvious symptoms such as pruritus or pain. 4. Have a full understanding of the study content and significance, implementation plan, potential benefits, existing risks and corresponding measures, as well as the rights and obligations of participants (including privacy protection and the right to withdraw freely); are willing to participate in this clinical study and can cooperate well. 5. Able to understand and sign the informed consent form, and willing to cooperate in completing the treatment and follow-up procedures. 6. Have no history of allergy to the known components of the selected traditional Chinese medicine (TCM) preparations. 7. Have not received any other treatment targeting the keloids within 6 months prior to the initiation of the study.
Exclusion criteria
Exclusion criteria: 1. Currently participating in other clinical trials; 2. Active infection or ulceration in the target keloid area; 3. Refusal of surgery or biopsy for pathological confirmation; 4. Hypertension, hypotension, heart diseases (including a history of myocardial ischemia, coronary heart disease, myocarditis), etc.; 5. Hepatic or renal insufficiency; 6. Infectious diseases (including viral hepatitis, syphilis, acquired immunodeficiency syndrome, etc.); 7. Hematological diseases (including coagulation disorders, anemia, leukemia, polycythemia vera, aplastic anemia, etc.); 8. Allergic constitution (urticaria, bronchial asthma, a history of allergies to two or more drugs or foods); 9. Respiratory diseases (chronic bronchitis, emphysema, bronchiectasis, pulmonary insufficiency, chronic obstructive pulmonary disease, interstitial pneumonia); 10. Gastrointestinal diseases (severe gastroduodenal ulcer, chronic gastroenteritis, chronic pancreatitis); 11. Urinary system diseases (chronic urinary tract infection, nephritis, nephrotic syndrome); 12. Endocrine system diseases (hyperthyroidism, diabetes mellitus, acromegaly, pituitary diseases, adrenal gland diseases, etc.); 13. Organic neurological diseases or mental illnesses (encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia); 14. Chronic skin diseases (especially infectious, allergic and inflammatory systemic skin diseases, such as generalized eczema, psoriasis, pemphigus, etc.); 15. Autoimmune diseases and collagen diseases (such as SLE, dermatomyositis, scleroderma, etc.); 16. Those with a long-term history of smoking, heavy drinking, or drug abuse; 17. Those with a recent history of malignant tumors not exceeding 5 years and currently requiring other treatments such as radiotherapy and chemotherapy; 18. Within the past five years, the individual has received blood donation or organ transplantation from others; 19. Pregnant, lactating, menstrual, or within one year after termination of pregnancy; 20. Other circumstances where the researcher deems it inappropriate to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The height of the scar above the surrounding skin;Patient and Observer Scar Assessment Scale (POSAS);The number and proportion of scars with recurrent hyperplasia;Vancouver Scar Scale (VSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Increased discomfort such as pruritus and pain;Hematoxylin-eosin (H.E.) staining, Masson staining, CD34 staining, and Ki-67 staining;Blood routine test;Transcriptomics, proteomics, and metabolomics detection;Liver function, renal function;Redness, swelling, and ulceration of the scar and surrounding skin;Scar lesion area (maximum length × maximum width);Drug allergy; | — |
Countries
China
Contacts
Public ContactLi Ming
Fujian Medical University Union Hospital
Outcome results
None listed