RESUMEN
BACKGROUND: The primary objective of this multicenter post-market study was to compare the cosmetic outcome of triclosan-coated VICRYL Plus sutures with Chinese silk sutures for skin closure of modified radical mastectomy. A secondary objective was to assess the incidence of surgical site infection (SSI). METHODS: Patients undergoing modified radical mastectomy were randomly assigned to coated VICRYL Plus antibacterial (Polyglactin 910) suture or Chinese silk suture. Cosmetic outcomes were evaluated postoperatively at days 12 (± 2) and 30 (± 5), and the evidence of SSI was assessed at days 3, 5, 7, 12 (± 2), 30 (± 5), and 90 (± 7). Cosmetic outcomes were independently assessed via visual analogue scale (VAS) score evaluations of blinded incision photographs (primary endpoint) and surgeon-assessed modified Hollander Scale (mHCS) scores (secondary endpoint). SSI assessments used both CDC criteria and ASEPSIS scores. RESULTS: Six Chinese hospitals randomized 101 women undergoing modified radical mastectomy to closure with coated VICRYL Plus suture (n = 51) or Chinese silk suture (n = 50). Mean VAS cosmetic outcome scores for antibacterial suture (67.2) were better than for Chinese silk (45.4) at day 30 (P < 0.0001)). Mean mHCS cosmetic outcome total scores, were also higher for antibacterial suture (5.7) than for Chinese silk (5.0) at day 30 (P = 0.002). CONCLUSIONS: Patients using coated VICRYL Plus suture had significantly better cosmetic outcomes than those with Chinese silk sutures. Patients using coated VICRYL Plus suture had a lower SSI incidence compared to the Chinese silk sutures, although the difference did not reach statistical significance.
Asunto(s)
Neoplasias de la Mama/cirugía , Poliglactina 910/uso terapéutico , Seda/uso terapéutico , Infección de la Herida Quirúrgica/microbiología , Suturas , Antibacterianos/uso terapéutico , Femenino , Humanos , Mastectomía/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: We aimed to find how self-reported sleep (measured by the St. Mary's Hospital Sleep Questionnaire) in postmenopausal women having hot flash activity was related to objective sleep (actigraphy), psychological and somatic symptoms [Women's Health Questionnaire (WHQ)], and cognitive test performance (computerized tests). A secondary aim was to find if self-reported sleep showed expected correlations with hyperarousal (Hyperarousal Scale). DESIGN: Drug trial baseline data from 88 healthy, postmenopausal women were retrospectively analyzed. Multivariate regression was used to adjust for confounder variables and test whether differences in self-reported sleep measures were systematically associated with differences in objective sleep, WHQ symptom measures, or cognitive test performance scores. RESULTS: Increased self-report scores for low sleep quality were associated with an increased risk of WHQ symptoms and reduced cognitive test performance. Self-reported sleep measures showed little correlation with their analogous objective measures. Self-reported low sleep quality proved most closely associated with the WHQ symptoms of tiredness, clumsiness, and difficulty concentrating. Women whose self-reported sleep-onset latency times were longer than the median overestimated their objective sleep onset time by 30 min, whereas the other women underestimated theirs by 15 min (P < 0.0001). Women whose self-reported total sleep was longer or shorter than the median, respectively, underestimated objective sleep times by 9 and 71 min (P < 0.0001). High hyperarousal scores were associated with underestimations of objective sleep. CONCLUSION: Self-reports of lower sleep quality were associated with increased WHQ psychological and somatic symptom measures and decreased cognitive test performance more than with differences in objective sleep. Self-reported trouble sleeping may signal problems independent from objectively low sleep quality, such as subjective distress or diminished cognitive function.