A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections.

"Declarations Conflict of interestO.Z. is an ad hoc speaker for PolyPid, Ltd.; Y.S., O.B., M.R., G.K., A.S., and N.E. are all employees of PolyPid, Ltd. or PolyPid, Inc. and own stock/stock options; N.W., H.T., and L.S. declare they have no conflicts of interest. Ethical approvalAll procedures performed in this study were reviewed and approved by the institutional review board at each participating site and in accordance with the principles of Good Clinical Practice, the 1964 Declaration of Helsinki and its later amendments, and the International Council of Harmonization guidelines, as well as local regulations. Informed consentAll patients provided written informed consent prior to any study procedures. Conflict of interest O.Z. is an ad hoc speaker for PolyPid, Ltd.; Y.S., O.B., M.R., G.K., A.S., and N.E. are all employees of PolyPid, Ltd. or PolyPid, Inc. and own stock/stock options; N.W., H.T., and L.S. declare they have no conflicts of interest."

"Funding Research funding support was provided by PolyPid, Ltd."

"The study protocol was reviewed and approved by the institutional review board at each participating site, and was implemented following the principles of Good Clinical Practice and the Declaration of Helsinki, and in accordance with International Council of Harmonization guidelines and local regulations before enrollment of participants began. All patients provided written informed consent prior to any study procedures. The study was registered at the clinicaltrials.gov: NCT03633123. The patients were randomized to receive D-PLEX administered along with SOC or the SOC control arm. The prophylactic antibiotic SOC treatment, based on the Israel Ministry of Health (IMOH) guidelines and standardized for all participating sites, included a first- or second-generation cephalosporin plus metronidazole administered intravenously within 30–60 min prior to surgery. Mechanical bowel preparation (MBP) was at the discretion of the surgeon. No oral antibiotic bowel preparation (OABP) was given to either arm. For patients randomized to the treatment arm, at the time of fascia, closure D-PLEX was applied along the entire length of the surgical wound, inclusive of the fascial suture line and soft tissues of the abdominal wall, subcutaneous fat, and dermis. The D-PLEX dose was determined based on the length of the surgical incision: a 5–10 cm incision received 5 g D-PLEX, an 11–20 cm incision received 10 g D-PLEX, and an incision ≥ 21 cm received 15 g D-PLEX."