ABSTRACT
BACKGROUND: Scar revisions have been increasing in number. Patient-reported outcome measures are one tool to aid scar modulation decision-making. The aims of this study were to determine patient, scar, and clinical risk factors for (1) low SCAR-Q Appearance, Symptom, and Psychosocial Impact scores and how this differs for children; and (2) the potential need for future scar revision surgery to better identify such patients in a clinical setting. METHODS: A multicenter international cross-sectional cohort study based on survey data of participants with traumatic, surgical, and burn scars attending plastic, hand, and burn clinics in four countries was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology checklist. Univariate analysis to identify risk factors and multivariable logistic analysis to select risk factors were completed. Collinearity for nonindependent factors and C statistic for model discrimination were also calculated. RESULTS: Seven hundred thirty-one participants completed the study booklet, and 546 participants (74.7 percent) had full data. Independent risk factors were determined to be a bothersome scar and perception of scarring badly for all three scales. Risk factors for self-reporting the need for future surgery included a health condition, scarring badly, scar diagnosis, prior scar revision, and low Psychosocial Impact scores. We did not identify evidence of multicollinearity. C statistics were high (0.81 to 0.84). CONCLUSIONS: This study is the first multicenter international study to examine independent risk factors for low patient-reported outcome measure scores and the potential need for future scar revision surgery. Patients that perceive themselves as scarring badly and having a bothersome scar were at a higher risk of scar appearance concern, an increased symptom burden, and poorer psychosocial impact scores. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.
Subject(s)
Burns/complications , Cicatrix/diagnosis , Patient Reported Outcome Measures , Postoperative Complications/diagnosis , Surgical Wound/complications , Adolescent , Adult , Aged , Aged, 80 and over , Body Image , Child , Cicatrix/etiology , Cicatrix/psychology , Cicatrix/surgery , Cross-Sectional Studies , Esthetics , Female , Humans , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/psychology , Postoperative Complications/surgery , Prognosis , Reoperation/statistics & numerical data , Severity of Illness Index , Young AdultABSTRACT
Many references exist in the literature identifying the usefulness of oxandrolone in treating muscle wasting due to various conditions including severe burns. However, there is an absence of dosage form alternatives as it is only available as tablets. The dose for children is weight based (0.1 mg/kg) which is difficult to achieve with the currently available tablets of 2.5 mg and 10 mg. The literature provides ample evidence of clinical importance but little guidance on extemporaneous oral liquid formulation of oxandrolone. In order to develop and validate an extemporaneous liquid formulation, suspensions of oxandrolone were developed using locally available (New Zealand) vehicles. Combinations of these vehicles with ethanol, as advised in some articles were also tried. Assay method was developed for oxandrolone using High Performance Liquid Chromatography (HPLC) and Mass Spectroscopy (LC-MS). The formulations were evaluated for stability as per the International Conference on Harmonization (ICH) stability guidelines. They were observed for physical and chemical stability at different time points over a period of 28 days. A stable and validated liquid formulation of oxandrolone has been developed which can be made under the hospital and community pharmacy conditions. The formula utilises commercially available oxandrolone tablets, crushed and dispersed in Simple Syrup BP or Orablend(®) vehicle. The formulation has confirmed stability for 21 days and can be easily made with locally available vehicles.