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Postoperative electron beam radiation therapy for the prevention of keloid recurrence: a randomized controlled clinical trial

Postoperative electron beam radiation therapy for the prevention of keloid recurrence: A Prospective Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076198
Enrollment
Unknown
Registered
2023-09-27
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid

Interventions

Single Radiation Fraction,sRF:Patient undergoes postoperative radiotherapy within 24 hours after surgical removal of keloids: 6MeV electron beam radiotherapy, dose 13Gy, frequency 1 time
Interrupted Radiation Fraction,iRF:Patient undergoes postoperative radiotherapy within 24 hours after surgical removal of keloids: 6MeV electron beam radiation therapy, dose 9Gy, frequency 2, interval

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 Age 13-60 years old 2 Diagnosed as keloid by at least 3 physicians 3 Keloid lesions are located in the trunk (chest, shoulders, and back) 4 Skin Fitzpatrick Type III/IV 5 No other invasive treatments such as glucocorticoid injection or laser therapy have been performed in the past 6 months

Exclusion criteria

Exclusion criteria: 1 Suffering from serious skin diseases such as psoriasis, scleroderma, etc. 2 Endocrine diseases such as diabetes, systemic lupus erythematosus and systemic sclerosis 3 Patients with systemic diseases with obvious or unstable clinical manifestations should be excluded based on the possibility of interfering with the research results, including malignant tumors, uncontrollable diabetes, uncontrollable hypertension, unstable pneumonia, organic diseases of kidney or liver, unstable myocardial ischemic diseases, dilated myocardial diseases, abnormal myocardial conduction diseases or unstable cardiovascular diseases.

Design outcomes

Primary

MeasureTime frame
Recurrence of keloids ;

Secondary

MeasureTime frame
Surgical incision healing ;tumorigenesis in surgical site;

Countries

China

Contacts

Public ContactXiaoLi Wu

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

wuxiaoli528@126.com+86 139 1796 3968

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026