Multicenter double-blinded randomized controlled trial of standard abdominal wound edge protection with surgical dressings versus coverage with a sterile circular polyethylene drape for prevention of surgical site infections: a CHIR-Net trial (BaFO; NCT01181206).
OBJECTIVE
To determine whether circular plastic wound edge protectors (CWEPs) significantly reduce the rate of surgical site infections (SSIs) in comparison to standard surgical towels in patients undergoing laparotomy.


BACKGROUND
SSIs cause substantial morbidity, prolonged hospitalization, and costs and remain one of the most frequent surgical complications. CWEPs have been proposed as a measure to reduce the incidence of SSIs.


METHODS
In this randomized controlled, multicenter, 2-arm, parallel-group design, patient- and observer-blinded trial patients undergoing open elective abdominal surgery were assigned to either intraoperative wound coverage with a CWEP or standard coverage with surgical towels. Primary endpoint was superiority of intervention over control in terms of the incidence of SSIs within a 30-day postoperative period.


RESULTS
Between September 2010 and November 2012, 608 patients undergoing laparotomy were randomized at 16 centers across Germany. Three patients in the device group and 11 patients in the control group did not undergo laparotomy. Patients' and procedural characteristics were well balanced between the 2 groups. Forty-eight patients discontinued the study prematurely, mainly because of relaparotomy (control, n=9; intervention, n=9) and death (control, n=4; intervention, n=7). A total of 79 patients experienced SSIs within 30 days of surgery, 27 of 274 (9.9%) in the device group and 52 of 272 (19.1%) in the control group (odds ratio=0.462, 95% confidence interval: 0.281-0.762; P=0.002). Subgroup analyses indicate that the effect could be more pronounced in colorectal surgery, and in clean-contaminated/contaminated surgeries.


CONCLUSIONS
Our trial shows that CWEPs are effective at reducing the incidence of SSIs in elective and clean or clean-contaminated open abdominal surgery.
*Department of Surgery, Klinikum rechts der Isar, Technische Universität München, Ismaningerstraße 22, 81675 Munich, Germany and CHIR-Net Munich †Institute for Medical Statistics and Epidemiology, Klinikum rechts der Isar, Technische Universität München, Ismaningerstraße 22, 81675 Munich, Germany ‡Department of Surgery, Kreisklinik Altötting, Vinzenz-von-Paul Straße 10, 84503 Altötting, Germany §Department of Surgery, Maria-Theresia-Klinik, Bavariaring 46, 80336 Munich, Germany ¶Department of Surgery, Ilmtalklinik GmbH Pfaffenhofen, Krankenhausstraße 70, 85276 Pfaffenhofen, Germany ‖Department of Surgery, Klinikum Bogenhausen, Englschalkinger Straße 77, 81925 Munich, Germany **Department of Surgery, Romed Klinikum Prien am Chiemsee, Harrasser Straße 61-63 83209 Prien, Germany ††Department of Surgery, Sozialstiftung Bamberg, Klinikum am Bruderwald, Buger Straße 80, 96049 Bamberg, Germany ‡‡Department of Surgery, Klinikum St Elisabeth Straubing GmbH, St-Elisabeth-Straße 23, 94315 Straubing, Germany §§Department of Surgery, St Marienkrankenhaus GmbH, Kampenstraße 51, 57072 Siegen, Germany ¶¶Department of Surgery, Klinikum Garmisch-Partenkirchen, Auenstraße 6, 82467 Garmisch-Partenkirchen, Germany ‖‖Department of Surgery, Kliniken Nordoberpfalz AG, Klinikum Weiden, Söllnerstraße 16, 92637 Weiden, Germany ***Johanniter-Krankenhaus Rheinhausen GmbH, Kreuzacker 1-7, 47228 Duisburg, Germany †††Department of Surgery, Evangelisches Krankenhaus Düsseldorf, Kirchfeldstraße 40, 40217 Düsseldorf, Germany ‡‡‡Department of Surgery, Rotkreuzklinikum München, Nymphenburger Straße 163, 80634 Munich, Germany §§§Department of Surgery, Klinikum Freising GmbH, Alois-Steinecker-Straße 18, 85356 Freising, Germany ¶¶¶Department of Surgery, Krankenhaus Landshut-Achdorf, Achdorfer Weg 3, 84036 Landshut, Germany.
André L
AL
Mihaljevic
Rebekka
R
Schirren
Mine
M
Özer
Stephanie
S
Ottl
Sybille
S
Grün
Christoph W
CW
Michalski
Mert
M
Erkan
Carsten
C
Jäger
Carolin
C
Reiser-Erkan
Victoria
V
Kehl
Tibor
T
Schuster
Jürgen
J
Roder
Ulf
U
Clauer
Carolin
C
Orlitsch
Tomas F
TF
Hoffmann
Reinhard
R
Lange
Thomas
T
Harzenetter
Phillip
P
Steiner
Milena
M
Michalski
Karl
K
Henkel
Josef
J
Stadler
Georg A
GA
Pistorius
Anja
A
Jahn
Robert
R
Obermaier
Robert
R
Unger
Roland
R
Strunk
Frank
F
Willeke
Holger
H
Vogelsang
Bert
B
Halve
Karl-Heinz
KH
Dietl
Hendrik
H
Hilgenstock
Alexander
A
Meyer
Hans-Jörg
HJ
Krämling
Markus
M
Wagner
Michael H
MH
Schoenberg
Florian
F
Zeller
Johannes
J
Schmidt
Helmut
H
Friess
Jörg
J
Kleeff
D058107:Abdominal Wound Closure Techniques; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D002985:Clinical Protocols; D004311:Double-Blind Method; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007813:Laparotomy; D008297:Male; D008875:Middle Aged; D020959:Polyethylene; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D016896:Treatment Outcome
D020959:Polyethylene