Keloid
Conditions
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
Interventions
OTHERhyperthermia
hyperthermia (using a heater, 44℃for 15 min)
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
China
Contacts
Primary ContactFeng Wang
Backup ContactLiang Shi
Outcome results
None listed