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

NCT05996614 — Not applicable, Unknown, 40 participants, Assiut University

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RegistryNCT05996614
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment40 (Estimated)
SponsorAssiut University (Other)
ConditionsSkin Burn
InterventionsPRP in skin grafts, conventional methods in skin grafts (Procedure)
Datesstart 2023-10-01 (estimated), primary completion 2024-12-01 (estimated), completion 2025-02-01 (estimated), first posted 2023-08-18, last updated 2023-08-18

Related Papers Related Patents Related Grants Related Experts
All trials for Skin Burn All trials of PRP in skin grafts All trials of conventional methods in skin grafts

-Summary

1. 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.
2. To evaluate the effect of PRP on wound healing on skin graft donor site.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
group with PRPExperimentalProcedure: PRP in skin graftsGroup of patients with post burn raw areas treated with application of platelet rich plasma
group without PRPExperimentalProcedure: conventional methods in skin graftsGroup of patients with post burn raw areas treated with conventional methods
  • PRP in skin grafts (Procedure): topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas
  • conventional methods in skin grafts (Procedure): fixation of the graft with stitches and staplers

+Outcome measures

Primary outcomes

  • histopathological biopsy from both groups by punch Biopsy (vancouver scale ) [3 months]: 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

+Eligibility

Sex: All, ages: 15 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

1. Age (15- 60 years).
2. Post burn Raw area less than 10 % of total body surface area .
3. Selected donor sites.

Exclusion Criteria:

1. Raw area due to other causes ( trauma, ischemia,..etc)
2. Patients with bleeding tendency.
3. Patients with comorbidities(diabetes, malignancy,..etc)

+Publications

  • Results publication: 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. PMID 34952738

+Investigators