1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response (Others) -  Photographic analysis, Patients satisfaction scores and patients demographic details
   
3. Who will be able to view these files?
   Response (Others) -  only ones approved by the study conductor personally or after publishing by fellow doctors for citation


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 (Others) -  Post publication in journals and thesis submission.


6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2055?
   Response - Immediately following publication. No end date.
   


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

Biofillers: A study to evaluate the efficacy and safety of Platelet poor plasma gel as an autologous dermal filler for facial rejuvenation

Background: Facial rejuvenation procedures are increasingly sought after for aesthetic enhancement and correction of imperfections. Platelet-poor plasma gel (Biofiller) has emerged as a promising autologous dermal filler, leveraging the cost effectiveness. However, there is limited evidence on its efficacy and safety for facial rejuvenation and aesthetic enhancements.

Aim and Objective: This study aims to evaluate the efficacy, safety and the application of platelet- poor plasma gel as an autologous dermal filler for aesthetic enhancements and facial rejuvenation. The primary objective is to assess the aesthetic improvement using the Global Aesthetic Improvement (GAI) scale and evaluate the patients’ satisfaction scores to highlight both the psychological and aesthetic benefits.

Materials and Methods: Patients who presented with various facial concerns like acne scars, lip and under-eye augmentation, facial asymmetry, burn scars etc. who attended the Dermatology and Venereology out-patient department at our tertiary care hospital will be receiving the treatment after taking a written and informed consent. Each treatment will involve a thorough patient evaluation, preparation of the platelet poor plasma gel from the patient’s own blood and precise injections according to their individual requirements. They will be assessed clinically before treatment sessions and at the end of the follow-up period of 3 months.

Platelet-Poor Plasma (PPP) gel preparation: Ten milliliters of patient’s blood is drawn and mixed with 1 mL anticoagulant acid citrate dextrose. A Two-staged centrifuging is performed using Digital 8R Dermafuge Centrifuge device. It is rotated at 2400 rotations per minute (RPM) for 5 min in the centrifuge machine. The plasma solution is withdrawn and centrifuged again at 2600 RPM for 10 min. The upper part (upper 2/3rd) that is platelet-poor plasma (PPP) is withdrawn in a Insulin syringe or 2ml syringe as per requirement and the lower part (lower 1/3rd) that is Platelet-rich plasma (PRP) is withdrawn in insulin (1 mL) syringes (which can be used for rejuvenation if required). Calcium gluconate is added in the PPP in the proportion of 0.01 mL/1 mL of PPP. It is incubated in hot water (heated in a metal container/hot water bath) at 60°C to 100°C (gradually reducing to 98°C) for 3-5 minutes and then in cold water bath in a metal container with initial temperature 7°C and gradually increasing to 10°C for 10 minutes. The temperatures are measured by digital thermometer. The viscous gel obtained is the PPP gel, a bio-filler.

 

Clinical assessment:

High quality digital colored photographs were taken for each participant before and at the end of the follow up period (3 months). Digital image analysis of the photographs was done to determine the percentage of improvement according to Global Aesthetic Improvement Scale (GAIS) 

It is a subjective assessment tool that rates the overall improvement in the appearance of the treated area on a 5-point scale, ranging from “worse” to “much improved”.

A standardized questionnaire is used to assess the patient’s aesthetic and psychological satisfaction. Likert scale was used to rate the responses, ranging from "very unsatisfied" to "very satisfied".

 

Treatment procedure: Topical 2.5% lidocaine plus 2.5% prilocaine anaesthetic cream is applied over the patient’s face on the areas to be treated for 45 min. Ten millilitres of patient’s blood is drawn and mixed with 1 mL anticoagulant acid citrate dextrose. Platelet-Poor Plasma gel is prepared as mentioned above. After cleaning of the topical anaesthetic cream, PRP is injected at multiple points over forehead, around eyes, and around lips over fine lines and wrinkles through insulin syringes (if required for rejuvenation). Then PPP gel filler is injected in the deep dermis with insulin syringes or 25G/27G of 50mm/38mm blunt tip cannula as per requirement at desired site with appropriate needles and precautions. It is injected linearly along the desired site depositing the bio-filler while withdrawing the needle for lip augmentation (linear threading technique). Injections are placed away from blood vessels with facial anatomy kept in mind. The sites are gently massaged to allow uniform distribution of the injected plasma gel to maintain the contour of the surrounding tissues. The patient is advised to avoid massage or extended pressure within the treated area for a week.