1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sumanjitboro@aiimsguwahati.ac.in].
   


6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-05-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

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.