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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Platelet Rich Plasma obtained with RegenKit®-BCT | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29762444 | Derived | Hersant B, SidAhmed-Mezi M, Picard F, Hermeziu O, Rodriguez AM, Ezzedine K, Meningaud JP. Efficacy of Autologous Platelet Concentrates as Adjuvant Therapy to Surgical Excision in the Treatment of Keloid Scars Refractory to Conventional Treatments: A Pilot Prospective Study. Ann Plast Surg. 2018 Aug;81(2):170-175. doi: 10.1097/SAP.0000000000001448. |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
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|
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| 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 |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |