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Not yet recruitingNCT06664268Updated Oct 29, 2024

Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars

An Early Phase 1 interventional study of Plasma rich in growth factors (PRGF-Endoret) and Fractional CO2 laser assisted PDT in Hypertrophic Scars and Burn Scar Patients, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Assiut University · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Hypertrophic Scars
  • Burn Scar Patients

Keywords

  • PRF
  • Fractional CO2 Laser
  • Postburn Hypertrophic Scars
03

In context

Cicatrix, Hypertrophic

129 studies on the registry are indexed under Cicatrix, Hypertrophic; 31 are open to participants now.

This study's planned enrollment of 30 is below the median of 36 across 106 interventional studies indexed under Cicatrix, Hypertrophic.

Browse Cicatrix, Hypertrophic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Group A

    fractional CO2 laser alone

    Device: Fractional CO2 laser assisted PDT

  • Active comparator
    Group B

    PRF Injection and fractional CO2 laser

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

Interventions

  • BiologicalPlasma 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 .

  • DeviceFractional 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 .

06

What researchers measure

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 months

  2. 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 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 32655245 ↗
  • 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. PubMed 38332516 ↗
  • 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. PubMed 33344342 ↗
  • 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. PubMed 33288326 ↗
  • 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. PubMed 27783851 ↗
  • 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. PubMed 38255655 ↗
  • 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. PubMed 38025602 ↗
  • 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. PubMed 16504849 ↗
  • 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. PubMed 28338518 ↗
  • 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. PubMed 31827977 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2024; primary completion for Nov 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2024
First posted
Oct 29, 2024
StartEst.
Nov 1, 2024
Primary completionEst.
Nov 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Oct 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06664268
Lead sponsor
Assiut University
Responsible party
Mohamed Emad Ahmed (plastic & reconstructive surgery Resident, Assiut University) — Principal investigator
First posted
Oct 29, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Oct 29, 2024

Study contacts

Mohamed Emad
Contact
Mohamed.16281237@med.aun.edu.eg
+201092785198
Mohamed Makboul, Professor
study director · Assiut University
Ahmed Ali, Assistant Proffesor
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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