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.

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Adrenal Cortex Hormones/*administration & dosage ; Keloid/*therapy ; Low-Level Light Therapy/*methods ; Patient Satisfaction/*statistics & numerical data ; Quality of Life/*psychology ; Triamcinolone Acetonide/*analogs & derivatives; Adrenal Cortex Hormones/pharmacology ; Adult ; Combined Modality Therapy ; Double-Blind Method ; Female ; Humans ; Injections, Intralesional ; Keloid/metabolism ; Keloid/psychology ; Male ; Middle Aged ; Postoperative Care ; Preoperative Care ; Prospective Studies ; Transforming Growth Factor beta/metabolism ; Treatment Outcome ; Triamcinolone Acetonide/administration & dosage ; Triamcinolone Acetonide/pharmacology ; Young Adult
    • Abstract:
      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).
      Competing Interests: The authors have declared that no competing interests exist.
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    • Molecular Sequence:
      ClinicalTrials.gov NCT04824612
    • Accession Number:
      0 (Adrenal Cortex Hormones)
      0 (Transforming Growth Factor beta)
      F446C597KA (Triamcinolone Acetonide)
      I7GT1U99Y9 (triamcinolone hexacetonide)
    • Publication Date:
      Date Created: 20220215 Date Completed: 20220224 Latest Revision: 20220224
    • Publication Date:
      20240829
    • Accession Number:
      PMC8846523
    • Accession Number:
      10.1371/journal.pone.0263453
    • Accession Number:
      35167583