Effect of PRF & Fractional CO2 Laser in Postburn Hypertrophic Scars

October 28, 2024 updated by: Mohamed Emad Ahmed, Assiut University

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

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
fractional CO2 laser alone
Device: 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 .
Active Comparator: Group B
PRF Injection and fractional CO2 laser
Device: 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 .
Biological: 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Assessment
Time Frame: 6 months

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
Time Frame: 6 months

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

  • scar thickness in millimeters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mohamed Makboul, Professor, Assiut university
  • Study Director: Ahmed Ali, Assistant Proffesor, Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF&Laser in Postburn Scars

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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