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

RegenLab

Status: Completed

Conditions: Keloid

Treatments: Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02922972

2014-A00163-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Platelet Rich Plasma

Experimental group

Description:

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.

Treatment:

Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT