Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University
About this trial
Recent advancements in scar management include the use of Plasma Rich Fibrin (PRF) injections and fractional CO2 laser treatments. Both modalities are considered innovative approaches that offer promising outcomes in scar revision .
Plasma Rich Fibrin (PRF) is a newer modality in regenerative medicine derived from the patient's own blood. Unlike platelet-rich plasma (PRP), PRF does not use anticoagulants during processing, leading to a natural fibrin matrix that supports prolonged release of growth factors and cytokines . This matrix has been shown to enhance wound healing and improve scar texture and appearance. Studies have demonstrated PRF's efficacy in treating various skin conditions, including acne scars and general skin rejuvenation, suggesting potential benefits for postburn scar management .
Fractional CO2 laser therapy is a well-established technique for scar treatment, including postburn scars. This technology utilizes laser energy to create microthermal zones in the skin, which stimulates collagen production and skin remodeling while minimizing damage to surrounding tissues . Clinical trials have validated the effectiveness of fractional CO2 lasers in reducing scar thickness and improving skin texture, making it a popular choice for scar revision .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged from 18 to 60 years
Mature post burn scars (more than 6 months).
Scar area does not exceed 5% of body surface area (TBSA).
Disqualifiers
Immature scars (less than 6 months).
Large scar area (more than 5%of body surface area (TBSA).
Previous scar treatment with other modalities.
Keloid scars.
Trial design
Design model
Parallel
Treatments tested in this trial
Plasma rich in growth factors (PRGF-Endoret)
Biological/VaccinePlasma Rich Fibrin (PRF) is a newer modality in regenerative medicine derived from the patient's own blood. PRF does not use anticoagulants during processing, leading to a natural fibrin matrix that supports prolonged release of growth factors and cytokines .This matrix has been shown to enhance wound healing and improve scar texture and appearance .
Fractional CO2 laser assisted PDT
DeviceFractional CO2 laser therapy is a well-established technique for scar treatment, including postburn scars. This technology utilizes laser energy to create microthermal zones in the skin, which stimulates collagen production and skin remodeling while minimizing damage to surrounding tissues .
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 1 intervention
Group B: Group BActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Clinical Assessment
1\. Clinical Assessment: By Vancouver Scar Scale (VSS) which consists of four items: 1. Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2 2. Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3 3. Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5 4. Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 \>5 mm 3 It has a score ranging from 0-13 , The VSS set a precedent for systematic scar assessment by collecting subjective assessments and using a semiquantitative approach. 0 (best) - 13 (worst)
Time frame
6 months2
Ultrasound Assessment
Ultrasound Assessment: to detect changes in hypertrophic scar thickness before, during, and after treatment By Measurement of * scar thickness in millimeters
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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