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

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 .

Study Overview

• Status: Recruiting
• Conditions: Keloid
• Intervention / Treatment: Other: hyperthermia

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Wang; Phone Number: 86-025-52271455; Email: fengwangcn@hotmail.com
• Study Contact Backup: Name: Liang Shi; Phone Number: 86-025-52271491; Email: liangshi@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Feng Wang, Ph.D.; Phone Number: 86-025-52271455; Email: fengwangcn@hotmail.com
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical Univerity
      • Contact: Feng Wang; Phone Number: 86-025-52271455; Email: fengwangcn@hotmail.com
      • Contact: Liang Shi; Phone Number: 86-025-52271491; Email: liangshi@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Sr-90 brachytherapy followed by hyperthermia.	Other: hyperthermia; hyperthermia (using a heater, 44℃for 15 min); Other Names: heater
No Intervention: Control group; Sr-90 brachytherapy alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Feng Wang, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Connective Tissue Diseases; Fibrosis; Body Temperature Changes; Heat Stress Disorders; Cicatrix; Collagen Diseases; Hyperthermia; Keloid
• Other Study ID Numbers: KY20240514-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No