OC-127 Chlorhexidine encoated thread for Trocar Incision after Laparoscopic Appendectomy and Cholecystectomy (NOVOTILAC-trial) – final results

Autor: M Golling, V Breul, W Steurer, C Hoyuela, J F Julián, P Baumann
Rok vydání: 2023
Předmět:
Zdroj: British Journal of Surgery. 110
ISSN: 1365-2168
0007-1323
Popis: Aim Of this multicenter, international, prospective, randomized, controlled, double blinded trial (NOVOTILAC) was to assess the effectiveness (e.g. SSI acc. to CDC) of chlorhexidine (CHD)-coated Novosyn sutures for fascial and skin closure (trocar incisions) following laparoscopic appendectomy (APP) & cholecystectomy (CHO) compared with non-coated Novosyn sutures. Methods This study was performed in spanish (2) & german centers (2) and recruited 377 pts, with 54 drop-outs, eventually including 323 pts., 297 were included for a 12 month follow up. Pt. were assigned for APP (164) and CHO (159). Pat. clientel (♀:161, ♂: 162) risk factors (ASA 1–4: 200/79/43/1) hypertension etc. were comparable. A two group Chi-Square test was used to compare proportions of events. Results Intraoperative organ pathology and inflammation (innocent appendix, phlegmonous or gangrenous appendicitis and symptomatic vs acute cholecystitis) varied substantially, as did duration of surgery (APP: 48±20.5, CHO: 65±30.7 min). Operating Surgeons included assistants (n=140), senior registrars (n=99) and Consultants (n=84). Adverse events (AE) occurred in 12,7%, 32 patients had one, 8 pts two, and 2 pts had 3 respectively 4 events. Serious adverse events (SAE) were seen in 14 pts., 1 pt died. SSIs were seen overall in 16/323 pts (5.0%). Assigned to the groups we found 10 SSIs / 162 pts (6.1%) in the Novosyn arm & 6 SSIs / 158 pts (3.7%) in the Novosyn-CHD arm (n.s.). Incidence/severity of the infection required no postoperative revision operation. Conclusion The Chlorhexidine-coated Novosyn sutures (Novosyn-CHD) did not significantly reduce wound infections following laparoscopic appendectomy & cholecystectomy.
Databáze: OpenAIRE
Externí odkaz: