Back to resultsTreatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
Primary Purpose
Keloid
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
Sponsored by
About this trial
This is an interventional treatment trial for Keloid focused on measuring Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet Rich Plasma
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of the scar using Vancouver scale.
The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.
prirutis severity
The efficacy of the treatment was also assessed on the Pruritus severity
Pain assessment
pain assessment during injections were also scored using the VAS.
patient satisfaction
Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS
Adverse events
Adverse events were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02922972
Brief Title
Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
Official Title
Efficay of Autologous Platelet Rich Plasma Obtained With RgenKit-BCT in the Prevention and the Treatment of Keloid Scars
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regen Lab SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid scar, Wound healing, Platelet-Rich Plasma, RegenLab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Autologous Platelet Rich Plasma obtained with RegenKit®-BCT
Other Intervention Name(s)
RegenKit®-BCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients achieving a complete remission of their keloid scar 2 years after the end of treatment.
Description
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 Outcome Measure Information:
Title
Evaluation of the scar using Vancouver scale.
Description
The efficacy of the treatment was also assessed and determined using the Vancouver scar scale.
Time Frame
24 months
Title
prirutis severity
Description
The efficacy of the treatment was also assessed on the Pruritus severity
Time Frame
24 months
Title
Pain assessment
Description
pain assessment during injections were also scored using the VAS.
Time Frame
3 months
Title
patient satisfaction
Description
Patient satisfaction at the end of follow-up was assessed using a 0-10 VAS
Time Frame
24 months
Title
Adverse events
Description
Adverse events were reported.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29762444
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Keloid Scar by Autologous Platelet Rich Plasma Obtained With RgenKit-BCT
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