Clinical and Ultrasound Assessment of Efficacy of Plasma Rich Fibrin (PRF) Injection and Fractional CO2 Laser in Treatment of Postburn Hypertrophic Scars: a Randomized Controlled Clinical Trial
| Registry | NCT06664268 |
|---|---|
| Status | Not yet recruiting |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 30 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Hypertrophic Scars, Burn Scar Patients |
| Interventions | Plasma rich in growth factors (PRGF-Endoret), Fractional CO2 laser assisted PDT (Biological, device) |
| Dates | start 2024-11-01 (estimated), primary completion 2025-11-01 (estimated), completion 2025-12-01 (estimated), first posted 2024-10-29, last updated 2024-10-29 |
Related Papers Related Patents Related Grants Related Experts
All trials for Hypertrophic Scars All trials for Burn Scar Patients All trials of Plasma rich in growth factors (PRGF-Endoret) All trials of Fractional CO2 laser assisted PDT
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 .
Postburn scars often result in significant functional and aesthetic challenges for plastic surgeons. These scars can cause physical limitations, psychological distress, and a decrease in quality of life. Traditional treatments, including topical therapies, silicone gel sheets, and surgical interventions, frequently fall short in providing optimal results, particularly for extensive or complex scars .
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 .
Despite the individual benefits of PRF and fractional CO2 laser treatments, there is a lack of direct comparative studies assessing their relative efficacy in postburn scar management. Comparative research is essential to determine which treatment provides superior outcomes and to guide clinical decision-making .
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A | Active comparator | Device: Fractional CO2 laser assisted PDT | fractional CO2 laser alone |
| Group B | Active comparator | Biological: Plasma rich in growth factors (PRGF-Endoret); Device: Fractional CO2 laser assisted PDT | PRF Injection and fractional CO2 laser |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * 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). Exclusion Criteria: * 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.