Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid
- Conditions
- Keloid
- Interventions
- Other: hyperthermia
- Registration Number
- NCT06431360
- Brief Summary
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 .
- Detailed Description
Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- The patient was clinically diagnosed with keloid, and the keloid area was clean without rupture and exudation；
- Body surface keloid thickness: 2~5mm, diameter ≥10mm.
- Women who plan to become pregnant within 3 months or are pregnant or breastfeeding;
- Patients with cicatricial constitution;
- Abnormal coagulation function;
- Patients who have received an adequate dose or course of radiation therapy;
- People with previous immune system diseases, diabetes and other metabolic diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group hyperthermia Sr-90 brachytherapy followed by hyperthermia.
- Primary Outcome Measures
Name Time Method Vancouver Scar Scale (VSS) scores once every 3 months for 1 year after the last treatment 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).
Patient and Observer Scar Assessment Scale (POSAS) scores once every 3 months for 1 year after the last treatment 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical Univerity
🇨🇳Nanjing, Jiangsu, China