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

Table 2 Study visits of the Poniy 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 infection^a			×^b	×^b	×^b	×^b	×^b
Documentation of other wound complications^c			×				×
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			×	×	×	×	×

^aBy blinded wound assessor according to definition of US Centers for Disease Control and Prevention
^bIn case of surgical site infection, a microbiological swab according to local practice should be obtained for microbiological specification and antimicrobial testing
^cDocumented as ‘yes’ if blister formation and ‘no’ otherwise

ISSN: 1745-6215