An interventional study of hyperthermia in Keloid, sponsored by Nanjing First Hospital, Nanjing Medical University. Recruiting at 2 sites in China. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment
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
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's planned enrollment of 80 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Sr-90 brachytherapy followed by hyperthermia.
Other: hyperthermia
Sr-90 brachytherapy alone.
hyperthermia (using a heater, 44℃for 15 min)
Also known as: heater
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.
Time frame: 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).
Time frame: once every 3 months for 1 year after the last treatment
Plan to share: No
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Nanjing First Hospital, Nanjing Medical University →