Clinical trial NCT06664268: Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hypertrophic Scars
Burn Scar Patients
Keywords: PRF
Fractional CO2 Laser
Postburn Hypertrophic Scars
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed description: 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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Assessment
timeFrame: 6 months
measure: Ultrasound Assessment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Makboul, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ahmed Ali, Assistant Proffesor
role: STUDY_DIRECTOR
References:
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