Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

Study Overview
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Brief Summary
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This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.

Official Title
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A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.

Conditions
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Skin Graft

Intervention / Treatment
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* Biological: Autologous Platelet Rich Plasma
* Biological: Keratinocyte suspension
* Other: Standard dressings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skin graft donor sites total surface < 15% BSA Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area Exclusion Criteria: Patients treated with immunosuppressors Patients treated with corticoids Patients suffering from terminal renal insufficiency Patients suffering from severe peripheral arteriopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage. | Other: Standard dressings<br>* Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.<br>|
| Experimental: PRP<br>PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group. | Biological: Autologous Platelet Rich Plasma<br>* Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.<br>Other: Standard dressings<br>* Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.<br>|
| Experimental: PRP+K<br>Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group. | Biological: Autologous Platelet Rich Plasma<br>* Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.<br>Biological: Keratinocyte suspension<br>* Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.<br>Other: Standard dressings<br>* Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Wound Healing | Time required for complete epithelialization in days | Post operative day 5 and every other day thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement. | Post operative day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin graft donor site healing, skin, wound, platelet concentrate, keratinocytes, burns