Keloid
Conditions
Keywords
Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab
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.
Interventions
DEVICEAutologous 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.
Sponsors
Regen Lab SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the scar using Vancouver scale. | 24 months | The efficacy of the treatment was also assessed and determined using the Vancouver scar scale. |
| prirutis severity | 24 months | The efficacy of the treatment was also assessed on the Pruritus severity |
| Pain assessment | 3 months | pain assessment during injections were also scored using the VAS. |
| patient satisfaction | 24 months | Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS |
| Adverse events | 24 months | Adverse events were reported. |
Outcome results
None listed