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Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

Primary Purpose

Skin Burn

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP in skin grafts
conventional methods in skin grafts
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Burn

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age (15- 60 years). Post burn Raw area less than 10 % of total body surface area . Selected donor sites. Exclusion Criteria: Raw area due to other causes ( trauma, ischemia,..etc) Patients with bleeding tendency. Patients with comorbidities(diabetes, malignancy,..etc)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    group with PRP

    group without PRP

    Arm Description

    Group of patients with post burn raw areas treated with application of platelet rich plasma

    Group of patients with post burn raw areas treated with conventional methods

    Outcomes

    Primary Outcome Measures

    histopathological biopsy from both groups by punch Biopsy (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 ,(0-2mm)1,(2-5mm)2,(>5mm)3

    Secondary Outcome Measures

    Full Information

    First Posted
    October 7, 2022
    Last Updated
    August 10, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05996614
    Brief Title
    Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
    Official Title
    Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    February 2025 (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
    To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas. To evaluate the effect of PRP on wound healing on skin graft donor site.
    Detailed Description
    Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas. The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned. Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss. Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group with PRP
    Arm Type
    Experimental
    Arm Description
    Group of patients with post burn raw areas treated with application of platelet rich plasma
    Arm Title
    group without PRP
    Arm Type
    Experimental
    Arm Description
    Group of patients with post burn raw areas treated with conventional methods
    Intervention Type
    Procedure
    Intervention Name(s)
    PRP in skin grafts
    Intervention Description
    topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas
    Intervention Type
    Procedure
    Intervention Name(s)
    conventional methods in skin grafts
    Intervention Description
    fixation of the graft with stitches and staplers
    Primary Outcome Measure Information:
    Title
    histopathological biopsy from both groups by punch Biopsy (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 ,(0-2mm)1,(2-5mm)2,(>5mm)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
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age (15- 60 years). Post burn Raw area less than 10 % of total body surface area . Selected donor sites. Exclusion Criteria: Raw area due to other causes ( trauma, ischemia,..etc) Patients with bleeding tendency. Patients with comorbidities(diabetes, malignancy,..etc)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ibrahim Ragab Ibrahim, master
    Phone
    00201060865454
    Email
    himo_nimo9@icloud.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mostafa Elsonbaty, prof
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34952738
    Citation
    Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.
    Results Reference
    result

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    Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas

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