Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars

NCT06664268 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PRF&Laser in Postburn Scars
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Hypertrophic Scars; Burn Scar Patients

Keywords

PRF; Fractional CO2 Laser; Postburn Hypertrophic Scars

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• Ultrasound Assessment

  Ultrasound Assessment: to detect changes in hypertrophic scar thickness before, during, and after treatment By Measurement of * scar thickness in millimeters

  6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

fractional CO2 laser alone

Device: Fractional CO2 laser assisted PDT

Group B

ACTIVE COMPARATOR

PRF Injection and fractional CO2 laser

Biological: Plasma rich in growth factors (PRGF-Endoret); Device: Fractional CO2 laser assisted PDT

Interventions

Plasma rich in growth factors (PRGF-Endoret) BIOLOGICAL

Plasma 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 .

Group B

Fractional CO2 laser assisted PDT DEVICE

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 .

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• Arsiwala NZ, Inamadar AC, Adya KA. A Comparative Study to Assess the Efficacy of Fractional Carbon Dioxide Laser and Combination of Fractional Carbon Dioxide Laser with Topical Autologous Platelet-rich Plasma in Post-acne Atrophic Scars. J Cutan Aesthet Surg. 2020 Jan-Mar;13(1):11-17. doi: 10.4103/JCAS.JCAS_142_19.

  PMID: 32655245 BACKGROUND

• Chen Y, Wei W, Li X. Clinical efficacy of CO2 fractional laser in treating post-burn hypertrophic scars in children: A meta-analysis: CO2 fractional laser in treating post-burn hypertrophic scars in children. Skin Res Technol. 2024 Feb;30(2):e13605. doi: 10.1111/srt.13605.

  PMID: 38332516 BACKGROUND

• Godara S, Arora S, Dabas R, Arora G, Renganathan G, Choudhary R. A Comparative Study on the Efficacy of Fractional CO2 Laser and Fractional CO2 Laser with Autologous Platelet-Rich Plasma in Scars. Indian Dermatol Online J. 2020 Sep 19;11(6):930-936. doi: 10.4103/idoj.IDOJ_174_20. eCollection 2020 Nov-Dec.

  PMID: 33344342 BACKGROUND

• Choi KJ, Williams EA, Pham CH, Collier ZJ, Dang J, Yenikomshian HA, Gillenwater TJ. Fractional CO2 laser treatment for burn scar improvement: A systematic review and meta-analysis. Burns. 2021 Mar;47(2):259-269. doi: 10.1016/j.burns.2020.10.026. Epub 2020 Nov 9.

  PMID: 33288326 BACKGROUND

• Castro AB, Meschi N, Temmerman A, Pinto N, Lambrechts P, Teughels W, Quirynen M. Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. J Clin Periodontol. 2017 Jan;44(1):67-82. doi: 10.1111/jcpe.12643. Epub 2016 Nov 24.

  PMID: 27783851 BACKGROUND

• Manole CG, Soare C, Ceafalan LC, Voiculescu VM. Platelet-Rich Plasma in Dermatology: New Insights on the Cellular Mechanism of Skin Repair and Regeneration. Life (Basel). 2023 Dec 25;14(1):40. doi: 10.3390/life14010040.

  PMID: 38255655 BACKGROUND

• Elver A, Caymaz MG. Novel approaches to the use of platelet-rich fibrin: A literature review. Saudi Dent J. 2023 Nov;35(7):797-802. doi: 10.1016/j.sdentj.2023.07.008. Epub 2023 Jul 10. No abstract available.

  PMID: 38025602 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.

  PMID: 16504849 BACKGROUND

• Tredget EE, Shupp JW, Schneider JC. Scar Management Following Burn Injury. J Burn Care Res. 2017 May/Jun;38(3):146-147. doi: 10.1097/BCR.0000000000000548.

  PMID: 28338518 BACKGROUND

• Lang TC, Zhao R, Kim A, Wijewardena A, Vandervord J, Xue M, Jackson CJ. A Critical Update of the Assessment and Acute Management of Patients with Severe Burns. Adv Wound Care (New Rochelle). 2019 Dec 1;8(12):607-633. doi: 10.1089/wound.2019.0963. Epub 2019 Nov 6.

  PMID: 31827977 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mohamed Makboul, Professor

  Assiut University

  STUDY DIRECTOR

• Ahmed Ali, Assistant Proffesor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Emad

CONTACT

+201092785198; Mohamed.16281237@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: plastic & reconstructive surgery Resident

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10