TABLE 1.
Study (year) | Country (no. of participating centers) | Surgery type | Intervention vs. control for fascial closure | Intervention vs. control for skin closure | Primary trial outcome | Eligible participants for IPDMA a |
---|---|---|---|---|---|---|
Diener et al. (2014) | Germany (24) | Elective midline laparotomy | PDS Plus vs. PDS II | n.a. | SSI c | 1,185 |
Ichida et al. (2018) | Japan (1) | Gastroenterological surgery | Polyglactin Plus vs. polyglactin | PDS Plus vs. PDS II | SSI c | 426 |
Justinger et al. (2013) | Germany/Switzerland (1) | Elective open abdominal surgery | PDS Plus vs. PDS II | n.a. | SSI c | 967 |
Mattavelli et al. (2015) | Italy (4) | Elective clean-contaminated colorectal surgery | PDS Plus vs. PDS II | Polyglactin Plus vs. polyglactin | SSI c | 246 |
Nakamura et al. (2013) | Japan (1) | Elective colorectal surgery | Polyglactin Plus vs. polyglactin | n.a. | SSI c | 192 |
Ruiz-Tovar et al. (2015) | Spain (2) | Surgery with intra-operative diagnosis of fecal peritonitis | Polyglactin Plus vs. polyglactin | n.a. | SSI c | 101 |
Ruiz-Tovar et al. (2020) | Spain (3) | Emergency surgery for infection or peritoneal contamination | PDS Plus vs. PDS II | n.a. | AWD and SSI c | 92 |
Baracs et al (2011) b | Hungary (7) | Elective colorectal laparotomy | PDS Plus vs. PDS II | n.a. | SSI d | 458 |
Abbreviations: TCS, triclosan-coated sutures; AWD, abdominal wall dehiscence; SSI, surgical site infection; PDS, polydioxanone, n.a. = not applicable.
Reasons for exclusion of participant: laparoscopic surgery (n = 859), use of a non-comparative suture (n = 50), excluded in the original trial (n = 141), missing case report form (n = 10) (see Figure 1).
Data from this trial were not included in the primary analysis due to unresolved data integrity concerns (Supplementary Material, page 6).
According to the Centers for Disease Control and Prevention criteria, within 30 days after surgery.
Assessed by telephone follow-up 30 days after discharge. Patients with wound related symptoms were invited for clinical assessment.