The efficacy of excision followed by intralesional 5-fluorouracil and triamcinolone acetonide versus excision followed by radiotherapy in the treatment of ear keloids: A randomized control trial

Burns. 2018 Sep;44(6):1489-1495. doi: 10.1016/j.burns.2018.02.017. Epub 2018 Mar 11.


Background: The ear is the common site for keloid formation especially in women after ear piercing. Surgery is the main stay of treatment in these lesions but there are large numbers of treatment failures in surgery alone.

Objective: The objective of this study was to compare the efficacy of post-excision intralesional 5-fluorouracil/triamcinolone acetonide (5-FU/TAC) and post-excision radiotherapy in the treatment of ear keloids.

Study design: A randomized controlled trial.

Setting: The study was conducted from May 2014 to January 2015 at Jinnah Burn and Reconstructive Surgery Centre, Allama Iqbal Medical College, Lahore.

Subject & methodology: After approval from the hospital ethical committee, 60 patients presented in the outpatient department fulfilling the inclusion criteria were selected and randomly assigned in two groups with the help of the random number table. Patients in group A had excision followed by intralesional 5-FU/TAC injections while patients of group B had excision followed by radiotherapy. Patients were assessed at 6 months after completion of treatment for efficacy (no recurrence within 6 months of treatment).

Results: In our study total of 60 patients completed the study, with 30 patients in each group. 7 patients (23.34%) in Group-A and 9 patients (30%) in Group-B were males while 23 patients (76.67%) in Group-A and 21 patients (70%) in Group-B were females i.e. male to female ratio is 1:2.75. Mean age was 31.8+6.48years. The comparison of frequency of efficacy in both groups showed that 73.33% (n=22) in Group-A and 43.33% (n=13) in Group-B had efficacy, p value was calculated as 0.01, showing a significant statistical difference.

Conclusion: Excision and intralesional 5-FU/TAC is an effective treatment for keloids on the ears.

Keywords: Ear keloids; Post-excision intralesional 5-FU/TAC; Post-excision radiotherapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Body Piercing / adverse effects
  • Combined Modality Therapy
  • Dermatologic Surgical Procedures / methods*
  • Drug Therapy, Combination
  • Ear / surgery*
  • Female
  • Fluorouracil / therapeutic use*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Injections, Intralesional
  • Keloid / etiology
  • Keloid / therapy*
  • Male
  • Radiotherapy / methods*
  • Treatment Outcome
  • Triamcinolone Acetonide / therapeutic use*


  • Immunosuppressive Agents
  • Triamcinolone Acetonide
  • Fluorouracil