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Table 2 Study visits of the Poniy trial

From: Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial

Activity Visit 1 (screening, inclusion) Visit 2 (operation + randomization) Visit 3 (postoperative day 5–7) Visit 4 (postoperative day 9–11) Visit 5 (discharge) Visit 6 (postoperative day 30–35) Optional visit (anytime between visits 2 and 6)
Inclusion and exclusion criteria ×       
Informed consent ×       
Medical history ×       
Physical examination ×       
Surgery   ×      
Randomization   ×      
Documentation of surgical site infectiona    ×b ×b ×b ×b ×b
Documentation of other wound complicationsc    ×     ×
Measurement of wound length    ×     
Documentation of wound pain (visual analogue scale, 1–10)    × × × × ×
Documentation of reoperation    × × × × ×
Documentation of adverse or serious adverse events   × × × × × ×
Documentation of antibiotic-therapy    × × × × ×
  1. aBy blinded wound assessor according to definition of US Centers for Disease Control and Prevention
  2. bIn case of surgical site infection, a microbiological swab according to local practice should be obtained for microbiological specification and antimicrobial testing
  3. cDocumented as ‘yes’ if blister formation and ‘no’ otherwise