Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination.Aims
Methods
The aim of this study was to determine whether the sequential
application of povidone iodine-alcohol (PVI) followed by chlorhexidine
gluconate-alcohol (CHG) would reduce surgical wound contamination
to a greater extent than PVI applied twice in patients undergoing
spinal surgery. A single-centre, interventional, two arm, parallel group randomised
controlled trial was undertaken, involving 407 patients who underwent
elective spinal surgery. For 203 patients, the skin was disinfected before surgery using
PVI (10% [w/w (1% w/w available iodine)] in 95% industrial denatured
alcohol, povidone iodine; Videne Alcoholic Tincture) twice, and
for 204 patients using PVI once followed by CHG (2% [w/v] chlorhexidine
gluconate in 70% [v/v] isopropyl alcohol; Chloraprep with tint).
The primary outcome measure was contamination of the wound determined
by aerobic and anaerobic bacterial growth from samples taken after
disinfection.Aims
Patients and Methods