The treatment of keloid and hypertrophic scar is challenging with no universally accepted mode for permanent ablation. Conventional therapies yield unpredictable results, significant complications and require elaborate hardware.
Objective: The objective was to establish the safety and efficacy of intralesional 5-fluorouracil (5-FU) for the treatment of keloids and hypertrophic scars.
Study design: Randomized controlled trial (RCT).
Place and duration: It was conducted at the Jinnah Burn and Reconstructive Surgery Center/Allama Iqbal Medical College, Lahore, Pakistan from May 2012 to March 2013.
Subjects and methods: We included 120 patients divided in two groups. The group A patients received intralesional triamcinolone acetonide (TAC) and the group B patients received both 5-FU and TAC. 8 injections at a week interval were given and patients were evaluated at the start of treatment and then at 4th and at 8th week during the treatment and then 4 weeks after the end of treatment. Patents were assessed for mean reduction in scar height, efficacy and complications.
Results: Total of 108 patients completed the study. The mean reduction in the scar height in group B (5-FU+TAC) 1.144+.4717 was markedly better than that of group A (TAC alone) 1.894+1.0751 (t=4.781, p=.000). The efficacy (defined previously as >50% reduction in initial scar height) was superior in group B 44 (77.2%) than that of group A 25 (49.0% (X2=9.260, p=.002). Recurrence was seen in 39.2% (20) of patients of the group A while in only 17.5% (10) of the cases of group B (P=0.012). Mean follow up was of 22 months.
Conclusion: 5-FU+TAC is safe, easy to administer and effective treatment for problematic scars and has the lower rate of recurrence on larger follow up.
Keywords: 5-Fluorouracil; Double blind; Hypertrophic scar; Keloid; Randomized control trial.
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