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. 2015 Mar 27;10(3):e0121187. doi: 10.1371/journal.pone.0121187

Table 2. Endpoints, surgical site infections and outcomes of included studies. NR: not recorded.

Study Outcomes SSI definition Duration of follow up Number of patients intervention group Number of patients control group SSI rate intervention group SSI rate control group number of patients excluded after randomisation (group)
Baier et al.39 SSI 1.) "The wounds were examined.  . . according to the CDC definition of SSI". 2.) Unclear if only superficial/deep SSI were assed or superficial/deep/organ space infections 1.) Daily till discharge. 2.) Phone contact on postoperative day 30 98 101 20 30 n = 33 • intervention: n = 16 reoperation, n = 1 withdrawn consent • control: n = 16 reoperation
Bätz et al. 40 SSI, microbiological results "Disruption of wound healing was defined as any spontaneous or surgical reopening of the abdominal wound with pus discharge" • Regular follow-up visits; • Duration unclear 25 25 1 7 NR
Cheng et al. 41 SSI, postoperative pain "SSIs were diagnosed according to the Centers for Disease Control and Prevention (CDC) criteria". Unclear if only superficial SSIs or all SSIs were recorded • "Incisions were inspected on a daily basis from the second postoperative day." • Clinical follow-up on postoperative day 30 34 30 0 6 n = 8 (group not reported)
Gamble & Hopton 42 SSI, microbiological results "A wound was recorded as infected if a discharge occured from it." • "Wounds were inspected on the third and eighth day and at the outpatient department within one month of discharge." 27 29 10 8 NR
Horiuchi et al. 26 SSI SSI frequency and properties were analyed according to the criteria of the United States Centers for Disease Control and Prevention (CDC). • Unclear 111 110 8 16 NR
Lee et al. 43 SSI (Wound infection) "was defined as any significant SSI necessitating wound opening or treatment with antibiotics." • "Patients were followed up for up to 3 weeks after operation." 61 48 1 7 n = 4 (group not reported)
Mihaljevic et al. 45,46 SSI, core body temperature Primary endpoint of this superiority trial was the incidence of SSIs (superficial, deep, organ-space) according to the definition of the Centers for Disease Control and Prevention (CDC) • Within 30 days after the operation (according to CDC) 300 294 27 52 n = 14 • intervention: n = 11 no laparotomy • control: n = 3 no laparotomy
Nyström & Bröte 47 SSI, microbiological results "Only wounds with definite accumulation of pus requiring opening or which emptied spontaneously were recorded as being infected" • Unclear. • "All patients were followed up postoperatively at the outpatients clinic or by answering a questionnaire sent by mail." 132 143 10 13 n = 14 • intervention: n = 11 no reason given • control: n = 3 no reason given
Nyström, Broomé et al. 30 SSI, bacteriological contamination "Wound sepsis was defined as pus emptying spontaneously or upon incision"; "Since the drape protects the abdominal incision wound only, infectious complications from other sites of the operative field are not reported" • Up to 30 days after the operation. • Detailed daily records of the postoperative course were kept. 70 70 7 6 NR
Pinkney et al. 48 SSI, Quality of life, Length of hospital stay, Cost effectiveness, Clinical efficacy of the device in relationship to the degree of contamination Superficial SSI.  . .based on the criteria developed by the Centers for Disease Control and Prevention (CDC) • Within 30 days after the operation (according to CDC) 369 366 91 93 n = 25 • intervention: n = 7 missing data, n = 6 no laparotomy • control: n = 7 missing data, n = 5 no laparotomy
Psaila et al. 28 SSI, bacteriological contamination "At least one of the following criteria was used to identify the presence of infection: 1. Erythema around the sutures or along the wound edge with an accompanying pyrexia, 2. Discharge of exudate or pus from the wound, 3. wound breakdown." • Unclear. • "Wounds were inspected daily after the third postoperative day" adhesive drape: 51 ring drape: 46 47 ring drape: 8; adhesive drape: 8 10 NR
Redmond et al. 49 SSI "Wounds were deemed infected when there was overt pus or a culture-positive discharge." • Wounds were assessed on days 5, 10 and 30 after operation 102 111 11 27 NR
Reid et al. 25 SSI, Experience of the surgeon with the device "Primary outcome was superficial and deep SSI occuring within 30 days of surgery, as defined by the Centers for Disease Control and Prevention (CDC)." • Within 30 days after the operation (according to CDC). 64 66 3 (superficial and deep) 15 (superficial and deep) n = 5 • intervention: n = 2 protocol violation, n = 1 death • control: n = 1 protocol violation, n = 1 death
Sookhai et al. 50 SSI "Postoperative wound infection was defined as the presence of a purulent discharge, a culture-positive wound discharge, pain/tenderness, localised swelling, erytema or cellulitis" • Within 30 days of surgery 170 182 23 54 NR
Theodoridis et al. 51 SSI, Feasibility of device "Wound infection, defined as wound dehiscence, pain or tenderness at the lower abdomen, localized swelling, redness, and heat or purulent discharge from the wound." • Unclear. • "During postoperative hospitalisation." 115 116 0 3 NR
Alexander-Williams et al. 52 SSI Mild wound infection (erythema), Moderate wound infection (exudate), Severe wound infection (pus) • On day 3 and day 7 postoperative for the first 96 patients. • On day 7 and day 10 for rest of patients. In those patients discharged before the tenth day it was considered that there was no infection if the wound had been normal on the seventh day and if no subsequent wound infection was reported by the patient when he returned to follow-up 84 83 9 (+n = 1 wound infection occured at drainage site, not laparotomy site) 10 n = 3 (group not reported)