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

Regen Lab SA15 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keloid

Interventions

Autologous Platelet Rich Plasma obtained with RegenKit®-BCTDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

Evaluation of the scar using Vancouver scale.

The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.

Time frame: 24 months

prirutis severity

The efficacy of the treatment was also assessed on the Pruritus severity

Time frame: 24 months

Pain assessment

pain assessment during injections were also scored using the VAS.

Time frame: 3 months

patient satisfaction

Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS

Time frame: 24 months

Adverse events

Adverse events were reported.

Time frame: 24 months

Data from ClinicalTrials.gov

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