Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid

Keloid Clinical Trial

Official title:

Effect of Strontium-90 Brachytherapy Combined With Hyperthermia in the Treatment of Keloid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431360
• Other study ID #: KY20240514-02
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Feng Wang
• Phone: 86-025-52271455
• Email: fengwangcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

Sr-90 brachytherapy: 6-7 Gy each time, twice a week for 3 weeks; Hyperthermia: using a heater, 44℃ for 15 min

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperthermia
• Keloid

Intervention

Other:
• hyperthermia
hyperthermia (using a heater, 44?for 15 min)

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanjing Medical Univerity	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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