Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Regen Lab SA
- Enrollment
- 15
- Primary Endpoint
- Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Platelet Rich Plasma
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.
Intervention: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT (Device)
Outcomes
Primary Outcomes
Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
Time Frame: 24 months
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.
Secondary Outcomes
- Pain assessment(3 months)
- Adverse events(24 months)
- prirutis severity(24 months)
- Evaluation of the scar using Vancouver scale.(24 months)
- patient satisfaction(24 months)