Methods
300 cases of Class III-IV. Wound-type emergency laparotomies were randomized with 1:1 ratio into conventional, dry wound care and ciNPWT treatment for 5 postoperative days. Primary endpoint of the trial was SSI requiring wound re-opening with removal of wound stitches or clips. Secondary endpoint was abdominal wall dehiscence requiring surgical re-intervention.
Results
10 surgical centres of the 12 accredited departments have started to recruit suitable candidates for the trial. In frame of the presentation we are ready to present the interim analysis results of the first 100 cases.
Conclusion
We aim to demonstrate (prove or rule out) the clinical effectiveness of ciNPWT in septic laparotomy surgery. We are awaiting firm responses on critical morbidity and financial questions regarding the technique, which remained open in the literature, so far.
Clinical relevance
ciNPWT may step up into primary choice in septic laparotomy for SSI prevention if clinical superiority and cost effectiveness can be demonstrated in a high qualitymulticentric RCT.
Acknowledgements
This presentation represents the cooperation of 10 institutions: Krisztina Varga, András Fülöp, Gábor Ferreira, László Harsányi, László Ternyik, Zsolt Káposztás, Zsolt Susán, Zsolt Szentkereszty, Zsolt Simonka, György Lázár, Balázs Mohos, Zoltán Lóderer, László Venczel, László Sikorszki, Éva Lilla Kovács, Zsolt Kincses, Balázs Samu Pánczél, Vilmos Szendrényi.