Estimating recurrence rate after application of the triple therapy of surgical excision, adjuvant steroid injection and silicone gel sheet in treating keloid patients from the North East India; an outcome analysis.

The triple therapy regime is a standard treatment option in the management of the keloid patients. There is no study depicting the recurrence and patient satisfaction following triple therapy in the North East Indian population. A prospective observational study (descriptive study) will be done on the operated keloid patients in AIIMS-Guwahati with adjuvant steroid and silicone gel application. Data will be collected using a pre-formed standard Performa that captured patient particulars, demography, patients complain, observers’ assessment, keloid severity score, surgery related data, recurrence and finally patient satisfaction. Informed consent will be taken in English, Hindi and Assamese language.

Few basic terms of the project:

a) Recurrence of an excised lesion will be defined as any indurated papule or nodule extending beyond the borders of a healed scar line of a previously excised lesion.

b) Patient satisfaction scoring will be categorised as (5-point Likert Scale)

-very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4) and very satisfied (5)

Interventions:

a) Surgical excision (intralesional/extra-lesional) will be done according to the keloid size and location.

-Primary closure, skin graft application and flap reconstruction, all these will be considered as surgery.

b) Steroid injection: At the post operative period (after suture removal) a total of 4-10 mg intralesional injection of TAC (Triamcinolone acetonide) from a 10 mg/cc will be administered once every 4 weeks for a minimum of 3 injections.

c) Silicone gel: After suture removal, application of silicone gel sheet will be started. Application time ranges from 12 to 24 hours a day (minimum 12 hours/ day), while treatment duration is not less than 6 months.

-Minimum follow up period of the study- 6 months