跳至主要内容
临床试验/CTRI/2024/12/078023
CTRI/2024/12/078023尚未招募不适用

To study the efficacy and safety of Platelet poor plasma gel as an autologous dermal filler for facial rejuvenation

Pacific Medical college and hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Aesthetic Improvement in pre and post procedure using Global Aesthetic Improvement Scale.(GAIS) GAIS ranges from 1-5 where 1 being very much improved and 5 being worse

研究概览

简要总结

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.      The primary aim of this study is to evaluate the efficacy, safety and aesthetic enhancements of platelet-poor plasma gel in facial rejuvenation. By utilizing the Global Aesthetic Improvement (GAI) scale and assessing patient satisfaction scores we aim to provide a comprehensive understanding of the psychological and aesthetic benefits of this procedure. 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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Willing to undergo biofiller for facial rejuvenation.
  • Willing to provide informed consent.
  • patients who are reliable to follow post procedure instruction.

排除标准

  • Patients who have undergone other cosmetic procedures within preceding 2 months Patients with unrealistic expectations.
  • Patient with conditions like a.
  • platelet dysfunction disorders b.
  • anticoagulants or antiplatelet drugs intake c.
  • Pregnancy and breast feeding e.
  • Active cancer or history of cancer within last 5 years f.
  • history or active autoimmune diseases.

结局指标

主要结局

Aesthetic Improvement in pre and post procedure using Global Aesthetic Improvement Scale.(GAIS) GAIS ranges from 1-5 where 1 being very much improved and 5 being worse

时间窗: baseline and 3 months

次要结局

  • Safety of PPP gel & Patients satisfaction score using Likerts score with standardised questionnaires evaluated after 3 months(Patients respond with a score of 1 to 5 where 1 being very much unsatisfied & 5 being very much satisfied after 3 months follow-up duration & mean value of all questions calculated.)

研究者

发起方
Pacific Medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

N Bharathi Kannamma

Pacific Medical College and Hospital, Udaipur

研究点 (1)

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