Influence of Platelet Concentrates on Wound Healing

Study Overview
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Brief Summary
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Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.

Detailed Description
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For in vitro testing on keratinocytes a platelet-mediator concentrate (PMC) was processed with a commercially available bed-side system (ATR®, Curasan, Germany). In a clinical study soft tissue defects (n=5) were treated using a combination of surgical debridement and autologous platelet rich plasma (PRP). Time of healing as determined by epithelization as well as Laser Doppler Imaging to visualize blood flow were analyzed. Additionally, changes in ease of surgical wound closure were determined. Finally, the quality of life of patients was assessed using a validated questionnaire.

Official Title
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The Influence of Autologous Platelet Concentrates on Human Keratinocyte Proliferation in Vitro and Wound Healing in Vivo

Conditions
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Platelet-Rich Plasma, Wound Healing Delayed

Intervention / Treatment
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* Combination Product: Platelet-Rich Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: exposed tendons, ligaments or bone for >3 weeks no healing tendency Exclusion Criteria: sepsis intensive care treatment continuous smoking pregnancy or breast feeding women participants of other studies.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Intervention<br>PRP injection into wound border | Combination Product: Platelet-Rich Plasma<br>* Adding PRP to wound bed during surgical debridement<br>* Other names: PRP, PMC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | Area of wound closure in % compared to initial size | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Flow | Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging | 4 weeks | 
| Wound Quality of Life | Quality of patients' life measured using Wound-QoL® Questionnaire before and after Intervention. Seventeen items are included in the Wound-QoL, which could be attributed to three subscales on everyday life, body, and psyche. The paper presents the overall score. A higher value correlates with more wound related burden, meaning a lower value indicates higher qulitiy of life. More information: https://www.ncbi.nlm.nih.gov/pubmed/24899053 | 21 days | 
| Ease of surgical wound closure | Estimated ease of surgical wound closure. The patients'wound was discussed by at least two surgeons to obtain agreement on a 14- point Ease of Closure scale. This was done on day 0 as well as day 21. The scale ranged from a score of 0, meaning the wound was closed or so small as to require no closure technique, to a score of 13, meaning that it was not possible to close the wound with known reconstructive surgical techniques. A higher value therefore correlates with more complex surgery. More information: https://www.ncbi.nlm.nih.gov/pubmed/10231510 | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet-Rich Plasma, Laser Doppler Imaging, Growth Factors, Wound Healing, Chronic wound healing disorder, Wound quality of life