Clinical trial NCT05996614: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Burn
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: histopathological biopsy from both groups by punch Biopsy (vancouver scale )
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mostafa Elsonbaty, prof
role: STUDY_CHAIR
References:
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.