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COMPLETED

NCT04411199

PHASE3

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

Sponsor: PolyPid Ltd.

View on ClinicalTrials.gov

Summary

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

Official title: D-PLEX 312 - Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

975

Start Date

2020-12-15

Completion Date

2025-05-10

Last Updated

2026-07-13

Healthy Volunteers

Conditions

Surgical Site Infection Colon Surgery Abdominal Surgery Post-Op Infection

Interventions

DRUG

D-PLEX

D-PLEX is a new formulation of extended release of Doxycycline.

OTHER

Standard of Care (SoC)

prophylactic, pre-operation per institution guidelines

Inclusion Criteria: 1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is \>20cm (target incision). 2. Subjects are preoperative hemodynamically stable. (BP≤180/110 and \>90/60 mmHg, and HR≤120 and \>60 bpm, and temperature ≤37.50C and \>35.50C). 3. Male or non-pregnant female. 4. Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure. 5. Subjects' age 18 years old and above at screening. 6. Subjects who sign the written Informed Consent Form. 7. Subjects who are willing and able to participate and meet all study requirements. 8. Survival expectancy of at least sixty days post randomization. Exclusion criteria: 1. Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon, diverticulitis, volvulus, etc.) 2. Subjects who underwent an intra-abdominal surgery within the last six months prior to randomization. 3. Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery. 4. Subjects undergoing concomitant major procedures in addition to the colorectal resection. Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor. 5. Subjects who received any anti-cancer treatment within the last four weeks of surgery. 6. Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last four weeks of the planned abdominal surgery. 7. Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past four weeks prior to randomization. 8. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients. 9. Subjects with known allergies to more than three substances. 10. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions. 11. Uncontrolled medical condition. 12. Subjects who underwent any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last three years. 13. Any subject with an active malignancy or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least three years.

Locations (58)

Augusta Univeristy

Augusta, Georgia, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Penn State Health Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Baylor University Medical Center

Dallas, Texas, United States

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

University Clinical Center Tuzla

Tuzla, Bosnia and Herzegovina

Cantonal Hospital Zenica

Zenica, Bosnia and Herzegovina

LLC American Hospital Network

Tbilisi, Georgia

LTD "Israeli - Georgian Medical Research Clinic Healthycore"

Tbilisi, Georgia

LTD New Hospitals

Tbilisi, Georgia

LTD Multiprofile Clinic Consillium Medulla

Tbilisi, Georgia

University Hospital Erlangen

Erlangen, Germany

University of Muenster

Münster, Germany

Bajai Szent Rokus Korhaz, Sebeszeti Osztaly

Baja, Hungary

Uzsoki Utcai Kórház, Sebészeti Osztály

Budapest, Hungary

Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet Sebeszeti es Ersebeszeti osztaly

Eger, Hungary

Bugát Pál Kórház, Gasztroenterológia - Sebészet

Gyöngyös, Hungary

Bács-Kiskun Megyei Kórház

Kecskemét, Hungary

Pest Megyei Flór Ferenc Kórház Sebészeti Osztály

Kistarcsa, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz, Sebeszeti Osztaly

Nyíregyháza, Hungary

University of Szeged, Faculty of Medicine, Dep.of Surgery

Szeged, Hungary

Fejer-County Saint George University Teaching Hospital, Department of Surgery

Székesfehérvár, Hungary

Our Lady of Lourdes Hospital

Drogheda, Ireland

Soroka Medical Center

Beersheba, Israel

Bnai Zion Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center

Rehovot, Israel

Assaf Harofeh Medical Center

Ẕerifin, Israel

IMSP Institutul de Medicina Urgenta

Chisinau, Moldova

IMSP Clinical republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

IMSP Institutul of Oncologic

Chisinau, Moldova

IMSP Spitalul Clinic Republican "Timofei Mosneaga"

Chisinau, Moldova

IMSP Spitalul Clinic Municipal "Gheorghe Paladi"

Chisinau, Moldova

IMSP Spitalul Clinic Municipal "Sfanta Treime"

Chisinau, Moldova

PHI General Hospital "Borka Taleski" Prilep

Prilep, North Macedonia

PHI University Clinic for digestive Surgery

Skopje, North Macedonia

PHI University Clinic for Surgical Diseases "st.Naum Ohridski - Skopje"

Skopje, North Macedonia

PHI Clinical Hospital - Shtip

Skopje, North Macedonia

PHI General Hospital - Strumica

Strumica, North Macedonia

Centrum Medyczne Med-Gastr

Lodz, Poland

Szpital Powiatowy im. Marii Skłodowskiej - Curie w Ostrowie Mazowieckiej SPZZOZ

Ostrów Mazowiecka, Poland

Unidade Local de Saúde da Região de Aveiro E. P. E.

Aveiro, Portugal

Centro Clinico Academico de Braga Associação - Hospital de Braga

Braga, Portugal

Unidade de Saúde Local da Guarda

Guarda, Portugal

Sf. Constantin Hospital

Brasov, Romania

Spitalul Clinic Judetean de Urgenta Craiova, Sectia Cbirurgie Generala II

Craiova, Romania

Spitalul Clinic Judetean de Urgenta Craiova, Sectia Chirurgie Generala III

Craiova, Romania

Mures County Clinical Hospital

Târgu Mureş, Romania

Spitalul Clinic JudeIean de Urgenta "Pius Brinzeu", Sectia Chirurgie Generala II

Timișoara, Romania

First Surgical Clinic

Belgrade, Serbia

Oncology Institute of Vojvodina

Kamenitz, Serbia

UCC Nis

Niš, Serbia

General Hospital Sremska Mitrovica

Sremska Mitrovica, Serbia

Health Center Valjevo

Valjevo, Serbia

Clinical Research Directory

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (58)