Effect of the combination of photobiomodulation therapy and the intralesional administration of corticoid in the preoperative and postoperative periods of keloid surgery: A randomized, controlled, double-blind trial protocol study

• Published in: PloS one 2022-02, Vol.17 (2), p.e0263453-e0263453
• Main Authors: Pires, Jefferson André, Bragato, Erick Frank, Momolli, Marcos, Guerra, Marina Bertoni, Neves, Leonel Manea, de Oliveira Bruscagnin, Meire Augusto, Ratto Tempestini Horliana, Anna Carolina, Porta Santos Fernandes, Kristianne, Kalil Bussadori, Sandra, Agnelli Mesquita Ferrari, Raquel
• Format: Article
• Language: English
• Subjects: Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - pharmacology; Adult; Biology and Life Sciences; Care and treatment; Cell division; Clinical trials; Collagen; Combined Modality Therapy; Corticosteroids; Dehydrogenases; Dermis; Double-Blind Method; Double-blind studies; Female; Fibroblasts; Growth factors; Health aspects; Health sciences; Humans; Injections, Intralesional; Keloid - metabolism; Keloid - psychology; Keloid - therapy; Keloids; Light; Light therapy; Low-Level Light Therapy - methods; Male; Medicine and Health Sciences; Middle Aged; Monochromatic light; Patient outcomes; Patient Satisfaction - statistics & numerical data; Physical Sciences; Plastic surgery; Postoperative Care; Preoperative Care; Prospective Studies; Quality assessment; Quality of life; Quality of Life - psychology; Questionnaires; Registered Report Protocol; Scars; Silicones; Statistical analysis; Statistical analysis of data; Surgery; Testing; Transforming Growth Factor beta - metabolism; Treatment Outcome; Triamcinolone Acetonide - administration & dosage; Triamcinolone Acetonide - analogs & derivatives; Triamcinolone Acetonide - pharmacology; Young Adult
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0263453

Keloid scars are characterized by the excessive proliferation of fibroblasts and an imbalance between the production and degradation of collagen, leading to its buildup in the dermis. There is no "gold standard" treatment for this condition, and the recurrence is frequent after surgical procedures removal. In vitro studies have demonstrated that photobiomodulation (PBM) using the blue wavelength reduces the proliferation speed and the number of fibroblasts as well as the expression of TGF-β. There are no protocols studied and established for the treatment of keloids with blue LED. Therefore, the purpose of this study is to determine the effects of the combination of PBM with blue light and the intralesional administration of the corticoid triamcinolone hexacetonide on the quality of the remaining scar by Vancouver Scar Scale in the postoperative period of keloid surgery. A randomized, controlled, double-blind, clinical trial will be conducted involving two groups: 1) Sham (n = 29): intralesional administration of corticoid (IAC) and sham PBM in the preoperative and postoperative periods of keloid removal surgery; and 2) active PBM combined with IAC (n = 29) in the preoperative and postoperative periods of keloid removal surgery. Transcutaneous PBM will be performed on the keloid region in the preoperative period and on the remaining scar in the postoperative period using blue LED (470 nm, 400 mW, 4J per point on 10 linear points). The patients will answer two questionnaires: one for the assessment of quality of life (Qualifibro-UNIFESP) and one for the assessment of satisfaction with the scar (PSAQ). The team of five plastic surgeons will answer the Vancouver Scar Scale (VSS). All questionnaires will be administered one, three, six, and twelve months postoperatively. The keloids will be molded in silicone prior to the onset of treatment and prior to excision to assess pre-treatment and post-treatment size. The same will be performed for the remaining scar at one, three, six, and twelve months postoperatively. The removed keloid will be submitted to histopathological analysis for the determination of the quantity of fibroblasts, the organization and distribution of collagen (picrosirius staining), and the genic expression of TGF-β (qPCR). All data will be submitted to statistical analysis. Trial registration: This study is registered in ClinicalTrials.gov (ID: NCT04824612).