Romanian Society of Pharmaceutical Sciences
 

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EFFICACY AND SAFETY OF REGEN-SIL® IN POST-OPERATIVE SCARS MANAGEMENT

ALEXANDRU GRIGOROVICI1, MIRELA SANDA CHERCIU2, CĂTĂLIN MIHAI POPESCU3, DELIA GABRIELA CIOBANU APOSTOL4, CRISTINA PREDA5, ALINA CĂLIN6, PETRUŢA AELENEI7*

1.Surgery Department, Faculty of Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, Universitatii 16, Iași 700115, Romania
2.Dermatology and Aesthetic Medical Center, “Arcadia” Hospital, Cicoarei 2, Iași 700620, Romania
3.Dermatology Department, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Dionisie Lupu 37, Bucharest 020021, Romania
4.Morpho – Functional Sciences – Pathology Department, Faculty of Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, Universitatii 16, Iași 700115, Romania
5.Endocrinology Department, Faculty of Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, Universitatii 16, Iași 700115, Romania
6.4th Surgery Clinic, “Sfântul Spiridon” Emergency County Hospital, Independentei 1, Iași 700111, Romania
7.Pharmacognosy Department, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy, Universitatii 16, Iași 700115, Romania

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Scars are the result of skin healing process after incisions, burns, acne and other wounds resulting from sports or trauma. Scars have physical, cosmetic and emotional implications. We present a prospective, randomized, open clinical study, assessing the efficacy and safety of REGEN-SIL® siliconic gel, in therapeutic management of post-operative hypertrophic and keloid scars compared to the efficacy and safety of another silicone gel available on pharmaceutical market, both products being authorized as medical devices with the same therapeutic indications. One hundred patients undergoing incisions in the anterolateral cervical region for thyroid and parathyroid glands surgical approach were randomly assigned into two groups: REGEN-SIL® group (50 patients) and Silicone Gel group (50 patients). The application of silicone-based products started immediately after the sutures were removed. The scars evolution was assessed through Vancouver Scar Scale (VSS) at baseline, at one month and three months of treatment onset. Side effects that could occur following administration of both products have been monitored. In addition, patient and physician satisfaction were evaluated. Ninety-three patients completed the trial and all assessments of scars revealed significantly better improvement scaring process in REGEN-SIL® group than in Silicone Gel group after 3 months of treatment onset. No side effects were recorded in both groups. This study has demonstrated the superior efficacy of REGEN-SIL® in therapeutic management of post-operative hypertrophic and keloid scars, and also a greater appreciation from the side of patients and physicians versus the comparative product.