800
Participants
Start Date
December 15, 2020
Primary Completion Date
April 14, 2025
Study Completion Date
May 10, 2025
D-PLEX
D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
Standard of Care (SoC)
prophylactic, pre-operation per institution guidelines
PHI University Clinic for digestive Surgery, Skopje
"PHI University Clinic for Surgical Diseases st.Naum Ohridski - Skopje", Skopje
Uzsoki Utcai Kórház, Sebészeti Osztály, Budapest
PHI Clinical Hospital - Shtip, Skopje
Pest Megyei Flór Ferenc Kórház Sebészeti Osztály, Kistarcsa
PHI General Hospital - Strumica, Strumica
Bugát Pál Kórház, Gasztroenterológia - Sebészet, Gyöngyös
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet Sebeszeti es Ersebeszeti osztaly, Eger
Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Sebeszeti Osztaly, Nyíregyháza
Bács-Kiskun Megyei Kórház, Kecskemét
Bajai Szent Rokus Korhaz, Sebeszeti Osztaly, Baja
University of Szeged, Faculty of Medicine, Dep.of Surgery, Szeged
"PHI General Hospital Borka Taleski Prilep", Prilep
Fejer-County Saint George University Teaching Hospital, Department of Surgery, Székesfehérvár
First Surgical Clinic, Belgrade
Health Center Valjevo, Valjevo
Penn State Health Milton S Hershey Medical Center, Hershey
UCC Nis, Niš
Oncology Institute of Vojvodina, Kamenitz
General Hospital Sremska Mitrovica, Sremska Mitrovica
Augusta Univeristy, Augusta
University of Muenster, Münster
Washington University School of Medicine, St Louis
Ochsner Medical Center, New Orleans
Assaf Harofeh Medical Center, Ẕerifin
Cantonal Hospital Zenica, Zenica
University Clinical Center Tuzla, Tuzla
Baylor University Medical Center, Dallas
University Clinical Centre of the Republic of Srpska, Banja Luka
University Hospital Erlangen, Erlangen
Spitalul Clinic Judetean de Urgenta Craiova, Sectia Cbirurgie Generala II, Craiova
Spitalul Clinic Judetean de Urgenta Craiova, Sectia Chirurgie Generala III, Craiova
"Spitalul Clinic JudeIean de Urgenta Pius Brinzeu, Sectia Chirurgie Generala II", Timișoara
Sf. Constantin Hospital, Brasov
Mures County Clinical Hospital, Târgu Mureş
Galilee Medical Center, Nahariya
Bnai Zion Medical Center, Haifa
Carmel Medical Center, Haifa
Sheba Medical Center, Ramat Gan
Kaplan Medical Center, Rehovot
Soroka Medical Center, Beersheba
Shaare Zedek Medical Center, Jerusalem
LLC American Hospital Network, Tbilisi
"LTD Israeli - Georgian Medical Research Clinic Healthycore", Tbilisi
LTD New Hospitals, Tbilisi
LTD Multiprofile Clinic Consillium Medulla, Tbilisi
Our Lady of Lourdes Hospital, Drogheda
IMSP Institutul de Medicina Urgenta, Chisinau
"IMSP Clinical republican Hospital Timofei Mosneaga", Chisinau
IMSP Institutul of Oncologic, Chisinau
"IMSP Spitalul Clinic Republican Timofei Mosneaga", Chisinau
"IMSP Spitalul Clinic Municipal Gheorghe Paladi", Chisinau
"IMSP Spitalul Clinic Municipal Sfanta Treime", Chisinau
Centrum Medyczne Med-Gastr, Lodz
Szpital Powiatowy im. Marii Skłodowskiej - Curie w Ostrowie Mazowieckiej SPZZOZ, Ostrów Mazowiecka
Unidade Local de Saúde da Região de Aveiro E. P. E., Aveiro
Centro Clinico Academico de Braga Associação - Hospital de Braga, Braga
Unidade de Saúde Local da Guarda, Guarda
Lead Sponsor
PolyPid Ltd.
INDUSTRY