Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT

Study Overview
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Brief Summary
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The aim of this prospective study is to assess the efficacy of autologous Platelet Rich Plasma prepared with RegenKit-BCT in the prevention and the treatment of keloid scars refractory to conventional treatments. Fifteen patients were included and received three PRP injection sessions with a one-month interval. The outcomes were assessed at baseline (before treatment), 3, 6, 12 and 24 months after the last injection session. Safety was assessed by reported adverse event analysis.

Detailed Description
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To evaluate the efficacy and the safety of platelet rich plasma in the treatment of keloid scars. This prospective, comparative study (before-after treatment) included 15 patients with keloid scars refractory to conventional treatment (corticoids, surgery, cryotherapy). The primary outcome was the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. Secondary outcomes were the Vancouver scar scale and pruritus severity scored at 3, 6, 12 and 24 months post treatment vs baseline.

Official Title
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Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars

Conditions
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Keloid

Intervention / Treatment
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* Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with keloid scars refractory to conventional treatments. The indication of PRP injection was based on the absence of response to corticosteroids alone or in combination with surgery after 4 sessions of infiltration and/or absence of response to other therapies. Exclusion Criteria: Patients younger than 18 years Pregnancy or breastfeeding Patients suffering from anemia patients with active skin disorder infection including active hepatitis or human infection virus infection Auto-immune disease such as Hashimoto, rheumatoid arthritis. Malignancy with or without metastatic disease Chemotherapy Anticoagulant therapy

Ages Eligible for Study
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Minimum Age: 18 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: Platelet Rich Plasma<br>Interventions: Four injections of PRP: The first injection of A-PRP after complete resection of the keloid scar,Three additional injections were administered with a one-month interval. | Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT<br>* After complete resection of the keloid scar, the first injection was administered before closure into the lesion resection bed and edges. Three additional injections were administered with a one-month interval.<br>* Other names: RegenKit®-BCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. | The efficacy of autologous platelet concentrate obtained with RegenKit®-BCT was assessed based on the percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the scar using Vancouver scale. | The efficacy of the treatment was also assessed and determined using the Vancouver scar scale. | 24 months | 
| prirutis severity | The efficacy of the treatment was also assessed on the Pruritus severity | 24 months | 
| Pain assessment | pain assessment during injections were also scored using the VAS. | 3 months | 
| patient satisfaction | Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS | 24 months | 
| Adverse events | Adverse events were reported. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab