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IRCT20150529022468N7 IRCT 2026-02-05 Iran University of Medical Sciences 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 2026-03-11 anticipated 17 Complete https://irct.ir/trial/88620 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the random allocation of treatments to the three keloid lesions in each patient, a block randomization method with appropriate allocation concealment will be employed. For this purpose, all possible sequences (6 orders) for arranging the three studied treatments—namely PRP, 5-FU, and the combined method—will be prepared. These sequences will be randomly organized into blocks, and each will be placed in separate, sealed envelopes. In each patient, the three lesions will be identified and labeled according to their anatomical position (upper, middle, and lower). At the time of intervention, an envelope will be randomly opened for the patient, and the treatment sequence inside will determine which treatment is allocated to which lesion: the first element of the sequence to the upper lesion, the second to the middle lesion, and the third to the lower lesion. For example, if the selected sequence is "BCA," the upper lesion will receive 5-FU, the middle lesion will receive the combined therapy, and the lower lesion will receive PRP. This process, along with the use of sealed envelopes, ensures statistically balanced allocation and prevents any bias by concealing the sequences until the moment of allocation, Blinding description: Given that the injection syringes will be identical in appearance and the contents of the syringes will be indistinguishable, patients will be blinded to the type of intervention they receive. Furthermore, each intervention will be labeled with a specific code, and the outcome assessor will be blinded to the intervention type when evaluating treatment results. 2 Keliod treatment. 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 at 3000 RPM for 10-14 minutes. Following centrifugation, the middle layer (PRF gel), which contains platelets, leukocytes, and growth factors, is separated and prepared as an injectable fibrin matrix. The injection volume will be 0.5-1 mL per square centimeter of the keloid surface area. The injection will be performed using an intralesional technique with a 27-30 gauge needle, at multiple points spaced 1 cm apart, until mild blanching is achieved. This protocol will remain consistent across all treatment sessions. Intervention 2: Intervention group: 5-Fluorouracil : Treatment of burn-induced keloids with 5-fluorouracil is administered via intralesional injection over three sessions at one-month intervals. To implement the protocol, a 50 mg/mL solution of 5-FU is prepared and, if needed for patient comfort, diluted with 1% lidocaine at a ratio of 2:8 (2 parts 5-FU to 8 parts lidocaine). Injection is performed using a fine-gauge needle (27-30 gauge) via the intralesional technique at multiple points spaced 0.5 to 1 cm apart. The needle is advanced to the mid-dermal layer, and the agent is injected slowly until localized blanching of the keloid is observed. The first treatment session is delivered on day 0 (baseline), the second on day 30 (±3 days), and the third on day 60 (±3 days). Intervention 3: Intervention group: Combination Therapy: In the combined method, a combination of the two studied interventions will be applied to the lesion. The volume and dosage used will be identical to those administered in the other treatment arms. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information"
public Mohammadreza Ghassemi
Motahari Educational and Medical Center , Rashid Yasami Street, Mirdamad District, Valiasr Street,Tehran
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8877 0031 Ghassemi.mr@iums.ac.ir Iran University of Medical Sciences scientific Mohammadreza Ghassemi
Motahari Educational and Medical Center , Rashid Yasami Street, Mirdamad District, Valiasr Street,Tehran
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8877 0031 Ghassemi.mr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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. 18 years no limit Both 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. Treatment - Drugs Treatment - Drugs Treatment - Drugs 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 at 3000 RPM for 10-14 minutes. Following centrifugation, the middle layer (PRF gel), which contains platelets, leukocytes, and growth factors, is separated and prepared as an injectable fibrin matrix. The injection volume will be 0.5-1 mL per square centimeter of the keloid surface area. The injection will be performed using an intralesional technique with a 27-30 gauge needle, at multiple points spaced 1 cm apart, until mild blanching is achieved. This protocol will remain consistent across all treatment sessions. Intervention group: 5-Fluorouracil : Treatment of burn-induced keloids with 5-fluorouracil is administered via intralesional injection over three sessions at one-month intervals. To implement the protocol, a 50 mg/mL solution of 5-FU is prepared and, if needed for patient comfort, diluted with 1% lidocaine at a ratio of 2:8 (2 parts 5-FU to 8 parts lidocaine). Injection is performed using a fine-gauge needle (27-30 gauge) via the intralesional technique at multiple points spaced 0.5 to 1 cm apart. The needle is advanced to the mid-dermal layer, and the agent is injected slowly until localized blanching of the keloid is observed. The first treatment session is delivered on day 0 (baseline), the second on day 30 (±3 days), and the third on day 60 (±3 days). Intervention group: Combination Therapy: In the combined method, a combination of the two studied interventions will be applied to the lesion. The volume and dosage used will be identical to those administered in the other treatment arms. 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. 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. Iran University of Medical Sciences Approved 2025-10-19 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences Hemmat Highway, Adjacent to Milad Tower Tehran Tehran Tehran Iran (Islamic Republic of)