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Keloid patients were randomized into the experimental and control groups. Experimental group: Strontium-90 (Sr-90) brachytherapy followed by hyperthermia. Control group: Sr-90 brachytherapy alone .
Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Sr-90 brachytherapy followed by hyperthermia. |
|
| Control group | No Intervention | Sr-90 brachytherapy alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperthermia | Other | hyperthermia (using a heater, 44℃for 15 min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) scores | The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location. comparable anatomic location. | once every 3 months for 1 year after the last treatment |
| Vancouver Scar Scale (VSS) scores | Physician evaluation comprised the use of the Vancouver Scar Scale (VSS) to evaluate the pigmentation (0=normal, 1=hypopigmented, 2=hyperpigmented), pliability (0=normal, 1= supple, 2=yielding, 3=firm, 4=banding, 5=contracture), height (0= flat, 1=5 mm), and vascularity (0=normal, 1=pink, 2=pink to red, 3=red, 4=red to purple, 5=purple). | once every 3 months for 1 year after the last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Wang | Contact | 86-025-52271455 | fengwangcn@hotmail.com | |
| Liang Shi | Contact | 86-025-52271491 | liangshi@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Feng Wang | Nanjing First Hospital, Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital | Recruiting | Nanjing | Jiangsu | 210006 | China |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| The First Affiliated Hospital of Nanjing Medical Univerity | Recruiting | Nanjing | Jiangsu | 210006 | China |
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |