A comparative clinical trial to study the effects of surgery combined with radiation therapy and surgery combined with 5- Fluorouracil in patients with ear Keloids

After approval from Ethical committee of our hospital, 120 patients presenting in the Department of Plastic Surgery through out patient department of Jinnah hospital, fulfilling the selection criteria will be included in the study. An informed consent will be obtained from them. Patients will be divided randomly in two groups by the help of random number table; Group A will be the patients of post excision radiotherapy and group B will be the patients post excision 5-FU. All the patients will be photographed and baseline assessment will be done before initiation of treatment by filling the proforma attached. All patients will undergo excision of the keloid under local anesthesia [2% lignocaine with 1:100,000 Adrenaline]. In group A, all patients will receive radiotherapy of total 10 Gy (2 fractions in two days) starting within 24 hours of excision. The target volume will be limited to the scar plus a 0.5-cm margin on both sides of suture lines. Ear lobe will be tapered away from the face and a direct anteroposterior field (with a small cone) will be used. In group B, excision followed by Intralesional 5-Fluorouracil [5-FU] injection in the dose of 50-150 mg divided between the excision margin and the wound bed. 5-FU will be given at two weekly interval. After giving local anesthesia [2% lignocaine +1:100,000 Adrenaline] using a 3cc syringe, 5-FU will be injected in the body of scar by using a 1cc syringe with premounted 27G needle, until slight blanching will be clinically visible. Assessment of patient will be done at 4, 8 weeks of treatment and 4 weeks after completion of treatment and then 6 monthly till 1 year for recurrance and mean scar reduction by the researcher.