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n = 33 • intervention: n = 16 reoperation, n = 1 withdrawn consent • control: n = 16 reoperation |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) |