RESUMEN
OBJECTIVE: To assess the effectiveness and safety of a topical silicone gel (BE + Gel reductor y reparador de cicatrices) and a polyurethane dressing (BE + Apósito reductor y reparador de cicatrices) on the evolution of scars of patients who were previously recruited in the emergency care unit while seeking wound care. METHOD: A single center, stratified observational, open label study was performed in the emergency care unit of Donostia Universitary Hospital (recruitment) and in the Biodonostia Health Research Institute (intervention). Scars located in unexposed body areas with the dressing, and scars located in exposed areas with either the gel or the dressing. Investigators assessed interventions at day 1 and on weeks 4, 8 and 12. Vancouver Scar Scale (VSS) and a photographical assessment were used to determine the scars evolution, and the subjective perception of the scar was evaluated by means of a questionnaire administered to the patients. RESULTS: Patients whose scars were treated with the silicone gel had an average initial VSS score of 5.4 ± 2.08. This value was reduced to 0.86 ± 1.17 after 90 days of treatment. Patients treated with the polyurethane dressing had an average initial VSS score of 5.8 ± 2.29. After 90 days of treatment, this average score was reduced to 0.33 ± 0.66. Positive evolution of scars was also supported by photographs and by a patient questionnaire. CONCLUSIONS: Both treatments appear to be safe and effective, objectively, and subjectively, in the context of scar evolution.
RESUMEN
Background: There is no evidence to date on immunogenic response among individuals who participated in clinical trials of COVID-19 experimental vaccines redirected to standard national vaccination regimens. Methods: This multicentre, prospective controlled cohort study included subjects who received a COVID-19 experimental vaccine (CVnCoV)(test group, TG) - and unvaccinated subjects (control group, CG), selected among individuals to be vaccinated according to the Spanish vaccination program. All study subjects received BNT162b2 as a standard national vaccination schedule, except 8 (from CG) who received mRNA-1273 and were excluded from immunogenicity analyses. Anti-RBD antibodies level and neutralising titres (NT50) against G614, Beta, Mu, Delta and Omicron variants were analysed. Reactogenicity was also assessed. Findings: 130 participants (TG:92; CG:38) completed standard vaccination. In TG, median (IQR) of anti-RBD antibodies after first BNT162b2 dose were 10740·0 BAU/mL (4466·0-12500) compared to 29·8 BAU/mL (14·5-47·8) in CG (p <0·0001). Median NT50 (IQR) of G614 was 2674·0 (1865·0-3997·0) in TG and 63·0 (16·0-123·1) in CG (p <0·0001). After second BNT162b2 dose, anti-RBD levels increased to ≥12500 BAU/mL (11625·0-12500) in TG compared to 1859·0 BAU/mL (915·4-3820·0) in CG (p <0·0001). NT50 was 2626·5 (1756·0-5472·0) and 850·4 (525·1-1608·0), respectively (p <0·0001). Variant-specific (Beta, Mu, Omicron) response was also assessed. Most frequent adverse reactions were headache, myalgia, and local pain. No severe AEs were reported. Interpretation: Heterologous BNT162b2 as third and fourth doses in previously suboptimal immunized individuals elicit stronger immune response than that obtained with two doses of BNT162b2. This apparent benefit was also observed in variant-specific response. No safety concerns arose. Funding: Partly funded by the Institute of Health Carlos-III and COVID-19 Fund, co-financed by the European Regional Development Fund (FEDER) "A way to make Europe".
