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

NCT06431360 | Recruiting

• 1 other identifier: KY20240514-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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 .

Conditions

Keloid

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Sr-90 brachytherapy followed by hyperthermia.

Other: hyperthermia

Control group

NO INTERVENTION

Sr-90 brachytherapy alone.

Interventions

hyperthermia OTHER

hyperthermia (using a heater, 44℃for 15 min)

Also known as: heater

Experimental group

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (2)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

The First Affiliated Hospital of Nanjing Medical Univerity

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Keloid

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Feng Wang

  Nanjing First Hospital, Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang

CONTACT

86-025-52271455; fengwangcn@hotmail.com

Liang Shi

CONTACT

86-025-52271491; liangshi@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of nuclear medicine department

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: May 14, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 30, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)