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Efficacy and Safety of Platelet-Rich Fibrin, 5-Fluorouracil, and Their Combination in the Treatment of Burn-Induced Keloids

Evaluation and Comparison of the Efficacy and Safety of Platelet-Rich Fibrin, 5-Fluorouracil, and Their Combination in the Treatment of Burn-Induced Keloids in Patients Treated with Intense Pulsed Light, Fractional CO2 Laser, or Their Combination

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150529022468N7
Enrollment
17
Registered
2026-02-05
Start date
2026-03-11
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keliod treatment.

Interventions

Intervention 1: Intervention group: Platelet-Rich Fibrin : For this procedure, approximately 10-20 mL of venous blood is drawn from the patient and centrifuged in special tubes without anticoagulant a

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged over 18 years Patients with a confirmed diagnosis of burn-induced keloid(s), with a minimum of 3 lesions Undergoing treatment with IPL laser, CO2 laser, or a combination of both. Having a total affected area of at least 10 × 10 cm² or a lesion with a minimum length of 10 cm. Not pregnant or lactating. Free from underlying medical conditions that could impair scar healing, such as diabetes mellitus or immunosuppression. Patient compliance with all therapeutic interventions and attendance at every treatment session.

Exclusion criteria

Exclusion criteria: Occurrence of pregnancy during the treatment or follow-up period. Development of hypersensitivity or any adverse reaction to any of the treatment interventions that would preclude continuation of therapy Diagnosis of malignancy or a systemic disease during the treatment or follow-up period. Onset of bacterial or viral skin infections during the treatment or follow-up period.

Design outcomes

Primary

MeasureTime frame
Vascularity. Timepoint: At baseline (before intervention) and at 1, 2, and 3 months after the initiation of treatment. Method of measurement: Vancouver scar scale.;Pigmentation. Timepoint: At baseline (before intervention) and at 1, 2, and 3 months after the initiation of treatment. Method of measurement: Vancouver scar scale.;Height/Elevation of the Lesion. Timepoint: At baseline (before intervention) and at 1, 2, and 3 months after the initiation of treatment. Method of measurement: Vancouver scar scale.;Pliability of the lesion. Timepoint: At baseline (before intervention) and at 1, 2, and 3 months after the initiation of treatment. Method of measurement: Vancouver scar scale.

Secondary

MeasureTime frame
Adverse Events. Timepoint: At 1, 2, and 3 months after the initiation of treatment. Method of measurement: Checklist.;Treatment tolerability. Timepoint: At 1, 2, and 3 months after the initiation of treatment. Method of measurement: Checklist.;Treatment satisfaction. Timepoint: At 1, 2, and 3 months after the initiation of treatment. Method of measurement: Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Ghassemi

Iran University of Medical Sciences

Ghassemi.mr@iums.ac.ir+98 21 8877 0031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026