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

Nanjing Medical University

Status: Enrolling

Conditions: Keloid

Treatments: Other: hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT06431360

KY20240514-02

Details and patient eligibility

About

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 .

Full description

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

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Experimental group

Experimental group

Description:

Sr-90 brachytherapy followed by hyperthermia.

Treatment:

Other: hyperthermia

Control group

No Intervention group

Description:

Sr-90 brachytherapy alone.