Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
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|ClinicalTrials.gov Identifier: NCT02922972|
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : November 15, 2019
Regen Lab SA
Information provided by (Responsible Party):
Regen Lab SA
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.
|Condition or disease||Intervention/treatment||Phase|
|Keloid||Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: 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.
Device: Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
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.
Other Name: RegenKit®-BCT
Primary Outcome Measures :
- 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 Outcome Measures :
- Evaluation of the scar using Vancouver scale. [ Time Frame: 24 months ]The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.
- prirutis severity [ Time Frame: 24 months ]The efficacy of the treatment was also assessed on the Pruritus severity
- Pain assessment [ Time Frame: 3 months ]pain assessment during injections were also scored using the VAS.
- patient satisfaction [ Time Frame: 24 months ]Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS
- Adverse events [ Time Frame: 24 months ]Adverse events were reported.
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