Keloid
Conditions
Interventions
Routine follow-up group after punch excision surgery:no
Superficial X-ray radiotherapy group following punch excision surgery:Superficial X-ray radiotherapy
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age range: 18–65 years old; 2.Isolated (single, focal, not involving the shoulder, neck, or lateral chest skin, located in the subclavicular region and excluding the 1st–6th costal cartilage regions) medium/large-sized keloids (with a length of 2.0–10.0 cm and a width less than 5.0 cm) on the chest, conforming to the staging criteria in the 2018 Chinese Clinical Treatment Recommendation Guidelines for Keloids (inflammatory stage: marked hyperemia, rapid peripheral infiltration, and other prominent inflammatory features; tumor stage: not markedly hyperemic or dark in color, protruding from the surface, and exhibiting rapid growth characteristic of a "tumor" type). 3.Clearly diagnosed and confirmed by histological examination; 4.Agree to be randomly assigned to groups and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. History of radiation dermatitis or active skin infection; 2. Pregnancy or lactation period; 3. Previous history of chest radiotherapy; 4. Severe cardiac diseases: including (1) Cardiac dysfunction / heart failure: NYHA Functional Class III–IV; (2) Severe arrhythmias: persistent ventricular tachycardia requiring treatment, second/third-degree atrioventricular block without a pacemaker implanted, QTc >= 500 ms; (3) Severe ischemic heart disease: recent (within 6 months) acute myocardial infarction; unstable angina; myocardial ischemia requiring hospitalization; (4) Severe structural heart disease: severe valvular disease (aortic/mitral stenosis or regurgitation): congestive heart failure resulting in an ejection fraction (EF) 5 × upper limit of normal (ULN); total bilirubin > 3 × ULN; (2) Liver fibrosis/cirrhosis status: Child-Pugh Class B or C; (3) Other severe liver conditions: active severe viral hepatitis (HBV DNA > 2×10^4 IU/mL, or ALT > 5×ULN); liver failure; hepatic encephalopathy; significant ascites (moderate to large volume); 6. Renal function indicators: (1) eGFR 3 × upper limit of normal (ULN); (2) Requirement for replacement therapy: need for dialysis (hemodialysis or peritoneal dialysis); (3) Accompanied by severe complications: active nephrotic syndrome; severe electrolyte disorders (e.g., hyperkalemia > 6.0 mmol/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month scar recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence-free survival, RFS;Dermatology Life Quality Index(DLQI);Vancouver Scar Scale(VSS);Patient and Observer Scar Assessment Scale(POSAS); | — |
Countries
China
Contacts
Public ContactHou Chenrong; Tang Shixing
Dematology Hospital of Southern Medical University
Outcome results
None listed