Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars

NCT ID: NCT06664268

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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 .

Conditions

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Hypertrophic Scars Burn Scar Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

fractional CO2 laser alone

Group Type ACTIVE_COMPARATOR

Fractional CO2 laser assisted PDT

Intervention Type 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 B

PRF Injection and fractional CO2 laser

Group Type ACTIVE_COMPARATOR

Plasma rich in growth factors (PRGF-Endoret)

Intervention Type 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 .

Fractional CO2 laser assisted PDT

Intervention Type 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 .

Interventions

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Plasma rich in growth factors (PRGF-Endoret)

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 .

Intervention Type BIOLOGICAL

Fractional CO2 laser assisted PDT

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 .

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Emad Ahmed

plastic & reconstructive surgery Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Makboul, Professor

Role: STUDY_DIRECTOR

Assiut University

Ahmed Ali, Assistant Proffesor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Mohamed Emad

Role: CONTACT

+201092785198

References

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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.

Reference Type BACKGROUND
PMID: 32655245 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38332516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33344342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33288326 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27783851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38255655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38025602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16504849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28338518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31827977 (View on PubMed)

Other Identifiers

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PRF&Laser in Postburn Scars

Identifier Type: -

Identifier Source: org_study_id

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