Efficacy of Platelet Rich Plasma Injection Plus Fat Grafting as Compared to Fat Grafting Alone on Burn Scar by Using Vancouver Scar Scale
Condition: Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: - Burn injuries always leave behind some permanent marks on the body of a victim.
      For the treatment of these scars, digital photography along with scar scales instrument are
      an important instrument for the patient's evaluation and finally for the follow-up of scars.
      Clinical evaluation of the patient after the use of Platelet concentration that it is a
      beneficial treatment which affects both on hard and soft tissues healing because of having
      growth factors deposited in PRP. Therefore, it can be used as an alternative to surgery which
      promotes safe and natural healing in such patients.

      Objectives: -

      1. To determine the efficacy of Platelet Rich Plasma plus fat grafting as compared to fat
      grafting alone on the Vancouver scar scale.

      Methodology: - An experimental controlled comparison trial study will be done on burn
      patients, admitted for recovery at the Plastic surgery department, Civil Hospital Karachi
      after the approval of the scientific committee and Institutional review board of Dow
      University of Health Sciences, Karachi. The study participants fulfilling the inclusion
      criteria giving consent will be randomly divided into two groups, one group will receive only
      fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting. The
      sample size of the study will be 52(26 in each group). Both the groups will be followed
      initially for 15 days of two visits then monthly two visits and finally after 6 months.
      Assessment of scar with Vancouver Scars Scale (VSS) will be done. The association of the PRP
      plus fat cells group and control group will be done by applying Chi-square statistical test.
      P-Value will be set for statistical significance level at <0.05.
    

Detailed description: 
      OBJECTIVE:

      1. To determine the Efficacy of platelet rich plasma injection (PRP) plus fat grafting as
      compared to fat grafting alone on burn scar by using Vancouver Scar Scale.

      HYPOTHESIS:

      Null hypothesis:

      There is no difference between the effect of Platelet-rich plasma (PRP) plus fat grafting and
      only fat grafting on the burn scar.

      Alternate hypothesis:

      There is a difference between the effect and adverse recovery findings of Platelet-rich
      plasma (PRP) plus fat grafting and only fat grafting on burn scar.

      OPERATIONAL DEFINITIONS:

      Platelet Rich Plasma (PRP): - Platelet-rich plasma is a blood product that has been enriched
      with platelets, as a concentrated source of autologous platelets. PRP contains several growth
      factors and other cytokines that stimulate the healing of bone and soft tissue.

      Fat Grafting: - It's a purification process in which fat can be removed from different parts
      of the body and injected on the face and other areas of the body through a gentle harvesting
      technique.

      Burn Scars: - Burn scars are the scars developed on any part of the body due to burning
      whatever cause which is depressed, raised, shiny, smooth, or rough, or darker than natural
      skin and maybe thicker and tougher than normal skin.

      METHODOLOGY:

      Setting:

      Plastic Surgery Department, Civil Hospital Karachi

      Study design:

      This will be a randomized control trial (RCT) study.

      Interventions:

      Group-I: will receive only fat grafting Group-II: will receive Platelet Rich Plasma plus fat
      grafting

      Duration:

      6 months after the approval of synopsis by the authorizes

      Sample size:

      The sample size was calculated by Open Epi online sample size software version 3.0. Take fat
      grafting and PRP, 70% maintenance of contour restoring as compared to only 31% of controls
      with fat grafting alone 7, 80% of power and 95 confidence levels. The total calculated sample
      size was 52. After randomization in 8 block with size of 8. we will take 64 (34 in each
      group).

      Block Randomization:

      Principal investigator will provide treatments to the both groups. Sixty-six subjects (33 in
      each group) will be randomizing in 8 block with size of 8 in two treatments group by using
      online web page sealedenvelope/ create a randomization list. The group I will be treated with
      fat grafting only from recipient to donor site. Group II will be treated with Platelet-rich
      plasma plus fat grafting. Both the groups will be followed initially for 15 days of two
      visits then monthly two visits and finally after 6 months to see if there are any differences
      between them in outcome (burn scare).

      Reference: Create a blocked randomization list | Sealed Envelope, 2021

      Inclusion criteria:

        1. All the buns patients of either age or sex coming with burn scar for plastic surgery.

        2. Give consent for this study

        3. Aesthetically not pleasant

        4. Exposed body parts

        5. Mature scar Exclusion criteria

      1. Immature scar 2. Systematic illness. 3. Sepsis 4. Psychiatric illness. 5. Pregnant women

      Data collection procedure:

      Before starting the project, the approval of the scientific Postgraduate committee and
      permission from the Institutional Review Board will be taken. All the patients who fulfill
      the inclusion criteria will be selected for this study. Written consent of the patient will
      also be taken. Then the patients will be divided into two parts on a random selection basis.
      The group I will be treated with fat grafting only from recipient to donor site. Group II
      will be treated with Platelet-rich plasma plus fat grafting. The fat cells will be prepared
      by Coleman's technique 11. The Platelet Rich Plasma (PRP) will be prepared from (9 - 18 ml).
      Whole blood of the same person with centrifugation of 3000 (RPm x 3min) with anti-coagulant
      Citrate Phosphorus Dextrose Adenine-I (CPDA-I) and 4000 (RPm x 15 min) with Calcium Chloride
      for activation of platelets and normal saline to resolve-centrifugation effect.

      This will be done by the highly qualifies pathologist of Dow University of Health Sciences
      free of cost. Both the groups will be followed initially for 15 days of two visits then
      monthly two visits and finally after 6 months. Assessment of scar with Vancouver Scars Scale
      (VSS) will be done. 16

      Data analysis procedure:

      The collected data will be analyzed through the Statistical Package for the Social Sciences
      version 20.0. The qualitative variables gender, size, and shape of scare and clinical changes
      will be presented in frequencies and percentages whereas quantitative variables like age,
      size of a scare, duration, and assessment of scar with (VSS) Vancouver scare scale will be
      evaluated through mean ± Standard deviation. The scar will be asses with the Vancouver Scars
      Scale (VSS) 16. Chi-square statistical test will be applied to assess the difference between
      the group. P-Value will be set for statistical significance level at <0.05. Efficacy of
      Platelet Rich Plasma Injection along with fat grafting as compared to fat grafting alone on
      burn scar in patients of plastic surgery ward of a tertiary care hospital of Karachi.
    

Intervention name(s): Platelet Rich Plasma plus fat grafting
Intervention type(s): Procedure
Intervention description(s): The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group-I: will receive only fat grafting; Group-II: will receive Platelet Rich Plasma and fat grafting
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-rich plasma; Fat grafting; Efficacy; wound healing; Burns scar; Regeneration