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Impact of Serial Preoperative Intralesional Steroid Injections on Auricular Keloid Recurrence: A Randomized Controlled Trial

Impact of Serial Preoperative Intralesional Steroid Injections on Auricular Keloid Recurrence: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250914007
Enrollment
54
Registered
2025-09-14
Start date
2025-09-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

auricular keloids Auricular keloid Intralesional corticosteroid injection Keloid recurrence Steroid softening

Interventions

Patients in the intervention group receive serial intralesional injections of Triamcinolone acetonide (40 mg/ml) every 4 weeks prior to surgery x 3 times. Surgical excision is then performed approxima
Experimental Drug,Active Comparator Procedure/Surgery
Intervention group- Serial Preoperative Intralesional Steroid Injections (Preoperative steroid injection+ Excision+ Postoperative steroid injection),Control group (Excision+ Postoperative steroid inje

Sponsors

Buriram Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older. 2. Patients who have been diagnosed with an auricular keloid by a plastic surgeon. 3. Patients who are willing to participate and are able to follow up according to the study's schedule.

Exclusion criteria

Exclusion criteria: 1. Patients under 18 years of age. 2. Patients who have previously received treatment for the keloid at the study site but have not shown a satisfactory response to the treatment. 3. Patients who have a history of a chronic or autoimmune disease, as well as those who are immunocompromised. 4. Patients who have received radiotherapy in the area of the keloid. 5. Patients who are pregnant or breastfeeding. 6. Patients who do not consent to participate in the study. 7. Patients who cannot be followed up according to the study's schedule.

Design outcomes

Primary

MeasureTime frame
Keloid recurrence rate All participants will be followed up monthly for a total of 12 months after the surgery By physical examination

Secondary

MeasureTime frame
Wound Complications: wound dehiscence, wound infection Every month for a total of 12 months after the surgery By physical examination,Intralesional steroid injection complication: Skin atrophy, Telangiectasia, Infection, Skin necrosis Every month after steroid injection and then monthly for a total of 12 months after the surgery By physical examination

Countries

Thailand

Contacts

Public ContactPremsak Sakarinpanichakul

Buriram Hospital

pkcfriend@yahoo.com0868738737

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026