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Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar

Primary Purpose

Burn Scar

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
platelet rich plasma injection in post burn facial scar
fat injection in post burn facial scar
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Scar

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients With Post Burn Facial Scar
  2. Age: 15 _60 Yrs Old
  3. Mature Burn Scar (After 3 Months)

Exclusion Criteria:

  1. Patients Less Than 15 Yrs Old
  2. Patients More Than 60 Yrs Old
  3. Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients)
  4. Patients With Burn Scar In Any Site Of Body Other Than Face

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    platelet rich plasma injection in post burn facial scar

    fat injection in post burn facial scar

    Arm Description

    prp in subgroup allocation 1:1 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes Do not chill the blood at any time before or during platelet separation. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.

    After aspiration of the fatty tissue, it is important that nonviable components of the aspirate, such as oil, blood, and local anesthetics are removed and, at the same time, the quality, integrity, and viability of the adipocytes and the inherent mesenchymal stem cells in the aspirate be maintained. Processing techniques are sedimentation , filtering and washing There is no consensus as to the optimal method of fat graft preparation.

    Outcomes

    Primary Outcome Measures

    vancouver scale
    Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2020
    Last Updated
    September 18, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04557514
    Brief Title
    Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar
    Official Title
    Comparative Study Between Fat Injection And Platelet Rich Plasma IN Post Burn Facial Scar Clinical And Histopathological Assessment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Best method in management of facial burn scar
    Detailed Description
    The stages of wound healing:proceed in an organized way and follow four processes: hemostasis, inflammation, proliferation and maturation. Although the stages of wound healing are linear, wounds can progress backward or forward depending on internal and external patient conditions. The four stages of wound healing are:Hemostasis Phase Hemostasis is the process of the wound being closed by clotting. Hemostasis starts when blood leaks out of the body. Inflammatory Phase Inflammation is the second stage of wound healing and begins right after the injury when the injured blood vessels leak transudate (made of water, salt, and protein) causing localized swelling. Proliferative Phase The proliferative phase of wound healing is when the wound is rebuilt with new tissue made up of collagen and extracellular matrix. Maturation Phase Also called the remodeling stage of wound healing, the maturation phase is when collagen is remodeled from type III to type I and the wound fully closes. Fat Injection In Facial burn scar:The effects of the lipofilling can be seen starting from 3 weeks after the procedure, in terms of better scar color, pliability, thickness, relief, itching, pain, scar vascularization and pigmentation. Indeed, autologous fat grafting makes the skin softer, more flexible and extensible; besides, the color seems similar to the surrounding unharmed skin. Platelet Rich Plasma In Facial burn scar: Impaired wound-healing and a long treatment course in severe burns as well as secondary complications originating from uncovered wounds motivate research to accelerate the wound-healing process and speed up re-epithelialization in burn patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burn Scar

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    platelet rich plasma injection in post burn facial scar
    Arm Type
    Active Comparator
    Arm Description
    prp in subgroup allocation 1:1 Obtain WB by venipuncture in acid citrate dextrose (ACD) tubes Do not chill the blood at any time before or during platelet separation. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed. Remove PPP and suspend the platelet pellets in a minimum quantity of plasma (2-4 mL) by gently shaking the tube.
    Arm Title
    fat injection in post burn facial scar
    Arm Type
    Active Comparator
    Arm Description
    After aspiration of the fatty tissue, it is important that nonviable components of the aspirate, such as oil, blood, and local anesthetics are removed and, at the same time, the quality, integrity, and viability of the adipocytes and the inherent mesenchymal stem cells in the aspirate be maintained. Processing techniques are sedimentation , filtering and washing There is no consensus as to the optimal method of fat graft preparation.
    Intervention Type
    Procedure
    Intervention Name(s)
    platelet rich plasma injection in post burn facial scar
    Intervention Description
    2 spins>>> st spin (separate plasma from blood) 2500 for 10 minutes nd spin (separate platelet rich part of plasma) 1500 for 10 minutes Taking lower part (platelet rich plasma ) Injection under scar after rigotomy
    Intervention Type
    Procedure
    Intervention Name(s)
    fat injection in post burn facial scar
    Intervention Description
    Anesthesia : general or local Lipoaspirate from abdomen or thigh using adrenaline(1\1000000) + ringer lactate + zylocaine Liposuction by canula no4 Sediment 3 layers : taking mid layer of fat and omit uppermost and lowermost layers Lipoinjection in fan shaped manner 10-20 cc according to site affected by canula no 1 .
    Primary Outcome Measure Information:
    Title
    vancouver scale
    Description
    Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients With Post Burn Facial Scar Age: 15 _60 Yrs Old Mature Burn Scar (After 3 Months) Exclusion Criteria: Patients Less Than 15 Yrs Old Patients More Than 60 Yrs Old Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients) Patients With Burn Scar In Any Site Of Body Other Than Face
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    abdelrahman mostafa shehata, doctor
    Phone
    01020905498
    Email
    abdelrahmanshehata084@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    youssef saleh, professor
    Phone
    01001166118
    Email
    Yossef66@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    wagdi mohamed, lecturer
    Organizational Affiliation
    lecturer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29928084
    Citation
    Bhooshan LS, Devi MG, Aniraj R, Binod P, Lekshmi M. Autologous emulsified fat injection for rejuvenation of scars: A prospective observational study. Indian J Plast Surg. 2018 Jan-Apr;51(1):77-83. doi: 10.4103/ijps.IJPS_86_17.
    Results Reference
    background
    PubMed Identifier
    27262706
    Citation
    Ozcelik U, Ekici Y, Bircan HY, Aydogan C, Turkoglu S, Ozen O, Moray G, Haberal M. Effect of Topical Platelet-Rich Plasma on Burn Healing After Partial-Thickness Burn Injury. Med Sci Monit. 2016 Jun 5;22:1903-9. doi: 10.12659/msm.895395.
    Results Reference
    background

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    Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar

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