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
About this trial
This is an interventional treatment trial for Skin Burn
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)
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
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
Learn more about this trial
Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
We'll reach out to this number within 24 hrs