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. 2022 Dec 20;23:1029. doi: 10.1186/s13063-022-06975-6

Table 3.

PAISI study visits (according to SPIRIT statement 2013 [28])

Study period
Inclu. Rand. Post-allocation Close-out
Study visit Number 1 2 3 4 5
Timepoint − 1–3 days day 0) day 5 day 10 (+5) day 30 (+5)
Informed consent X
Inclusion and exclusion criteria X
Randomization X
Intervention (IPI with 1500ml NaOCl/HOCl solution) X
Control (IPI with 1500ml Ringer solution) X
Demographical data X
Medical history and Charlson Comorbidity Index X
Medication with known effects on wound healing X
Physical examination X
Type of operation X
Duration of operation X
Level of contamination X
Type and length of incision X
Abdominal wall closure technique and suture material X
Presence of an enterostomy X
Use of wound edge protectors X
Changing of gloves X
Placement and type of-intra-abd. drains X
Postoperative medication with known effects on wound healing X X X
Documentation of SSI X X X
Documentation of other postoperative complications (Clavien Dindo and CCI) X X X
Documentation of re-operation X X X
Documentation of postoperative intra-abd. irrigation via irrigation-suction drainage system X X X
Documentation of AE/SAE of special interest X X X X
Duration of hospital stay X