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 (WBUS +TCM)
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, ultrasound promotes the penetration of TCM into scar lesions, exerting effects of infection control, inflammation inhibition, subsidence of redness and swelling, and relief of itching and pain.
Compared with conventional scar therapies, this approach achieves rapid symptom control, no secondary damage, no obvious side effects, a short recovery period, and high treatment comfort. It shows particularly significant advantages for large-area or multiple pathological scars throughout the body that are difficult to treat with traditional methods. Preliminary treatment in a small number of volunteers with multiple keloids has achieved satisfactory outcomes without obvious adverse reactions.
The purpose of this study is to verify the efficacy and safety of wide-band ultrasound combined with TCM preparation (Chuang Li Fu) in the prevention and treatment of keloids through this clinical trial.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
In this study design, surgically excised keloids were randomly assigned to 4 groups:
Blank control group (Group 0#) Ultrasound + TCM preparation group (Group 1#) Ultrasound + normal saline group (Group 2#) TCM gauze external application alone group (Group 3#) All treatments were administered once every 3 days, for a total of 10 sessions.After treatment, all keloid tissues were surgically removed and subjected to pathological examination to evaluate efficacy.
At 1 week after suture removal, all incisions received intervention with wide-band ultrasound combined with TCM preparations.Treatment was performed once every other week, for a total of 12 sessions.Subsequently, follow-up was conducted once monthly until 12 months after the last intervention.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- 2. fázis
- 1. fázis
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Li Ming Li, Doctor of Philosophy
- Telefonszám: +86 18259061605
- E-mail: fmulm@126.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
I-1 Multiple keloid lesions (≥2) on the body, requiring surgical excision and revision. The two targeted lesions shall be separated by at least 1 cm and located in the same anatomical region (e.g., abdomen, chest, upper extremity, lower leg, etc.).
I-2 Aged 14 to 60 years. I-3 The targeted keloid lesions have shown no significant spontaneous regression or continuous enlargement within the past 3-6 months,or are accompanied by obvious symptoms such as itching or pain.
I-4 Has fully understood the purpose, protocol, potential benefits, risks, countermeasures, and rights and obligations of the study (including privacy protection and voluntary withdrawal), and is willing to participate and cooperate well.
I-5 Able to understand and sign the informed consent form, and willing to comply with treatment and follow-up.
I-6 No history of allergy to any known components of the selected traditional Chinese medicine (TCM) preparation.
I-7 No prior treatment for the targeted keloid lesions within 6 months before study initiation.
Exclusion Criteria:
E-1 Currently participating in other clinical trials.E-2 Active infection or ulceration present in the targeted keloid area.E-3 Refusal to undergo surgery or biopsy for pathological confirmation.E-4 Hypertension, hypotension, or heart disease (including history of myocardial ischemia, coronary heart disease, myocarditis, etc.).E-5 Hepatic or renal insufficiency.E-6 Infectious diseases (including viral hepatitis, syphilis, AIDS, etc.).E-7 Hematological disorders (abnormal coagulation function, anemia, leukemia, polycythemia vera, aplastic anemia, etc.).E-8 Allergic constitution (urticaria, bronchial asthma, history of allergy to more than two drugs or foods).E-9 Respiratory diseases (chronic bronchitis, emphysema, bronchiectasis, pulmonary insufficiency, chronic obstructive pulmonary disease, interstitial pneumonia).E-10 Digestive system diseases (severe gastric and duodenal ulcers, chronic gastroenteritis, chronic pancreatitis).E-11 Urinary system diseases (chronic urinary tract infection, nephritis, nephrotic syndrome).E-12 Endocrine system diseases (hyperthyroidism, diabetes, acromegaly, pituitary diseases, adrenal diseases, etc.).E-13 Organic neurological diseases or mental illnesses (encephalitis, sequelae of brain trauma, epilepsy, schizophrenia, hysteria, depression, severe insomnia, neurasthenia).E-14 Chronic skin diseases (especially infectious, allergic and inflammatory systemic skin diseases, such as generalized eczema, psoriasis, pemphigus, etc.).E-15 Autoimmune diseases and collagen diseases (such as SLE, dermatomyositis, scleroderma, etc.).E-16 History of long-term smoking, alcohol abuse, or drug abuse.E-17 History of malignant tumor within the past 5 years, currently requiring other treatments such as radiotherapy and chemotherapy.E-18 Received blood transfusion or organ transplantation from others within the past 5 years.E-19 Pregnant, lactating, menstruating, or within 1 year after termination of pregnancy.E-20 Other conditions deemed unsuitable for participation in the study by the investigator.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Nincs beavatkozás: Blank control group (Group 0#)
No Intervention
|
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Kísérleti: Ultrasound + TCM preparation group (Group 1#)
The gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion, followed by treatment with a wide-band ultrasound therapeutic probe placed over the gauze.
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The ultrasound probe is placed over the gauze during treatment.
Gauze saturated with TCM preparation is applied onto the keloid lesion
|
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Kísérleti: Ultrasound + normal saline group (Group 2#)
A gauze saturated with normal saline is applied to the keloid lesion, and a wide-band ultrasound therapeutic probe is then placed over the gauze to perform treatment.
|
The ultrasound probe is placed over the gauze during treatment.
|
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Kísérleti: TCM gauze external application alone group (Group 3#)
Only gauze saturated with the traditional Chinese medicine (TCM) preparation was applied to the keloid lesion for 30 minutes (the gauze was covered with plastic wrap to enhance penetration and immersion).
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Gauze saturated with TCM preparation is applied onto the keloid lesion
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Vancouver Scar Scale (VSS)
Időkeret: up to 3 months
|
① After the first stage: the improvement in the experimental group was at least 2 points greater than that in the control group, with statistical significance.②
At follow-up endpoint: no obvious hypertrophic growth in any incision scar.
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up to 3 months
|
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Patient and Observer Scar Assessment Scale (POSAS)
Időkeret: up to 3 months
|
① At the end of Stage 1: The improvement in the experimental group was at least 6 points greater than that in the control group, with statistical significance. In addition, the three sub-items (vascularity, itching, pain) each improved by at least 2 points, with statistical significance. ② At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar. |
up to 3 months
|
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Scar height above the surrounding skin
Időkeret: up to 3 months
|
① At the end of Stage 1: The scar height in the experimental group was lower than that in the control group, with statistical significance.②
At follow-up endpoint: No obvious hypertrophic proliferation was observed in any incision scar.
|
up to 3 months
|
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Number and proportion of scar recurrence and hypertrophy
Időkeret: through study completion , an average 1.5 year
|
At follow-up endpoint, incisional recurrence rate will be lower than the 20% minimum recurrence rate of postoperative radiotherapy reported in literature.
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through study completion , an average 1.5 year
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Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 2025KY744-01
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
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