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

Completed · Phase 3

Conditions studied: Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection

In brief

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.

Key facts

Study ID

NCT04411199

Run by

PolyPid Ltd.

People needed

975

Starts

2020-12-15

Expected to finish

2025-05-10

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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).
• Male or non-pregnant female.
• Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure.
• Subjects' age 18 years old and above at screening.
• Subjects who sign the written Informed Consent Form.
• Subjects who are willing and able to participate and meet all study requirements.
• Survival expectancy of at least sixty days post randomization.

You may not qualify if…

• 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.)
• Subjects who underwent an intra-abdominal surgery within the last six months prior to randomization.
• 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.
• 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.
• Subjects who received any anti-cancer treatment within the last four weeks of surgery.
• Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, within the last four weeks of the planned abdominal surgery.
• Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past four weeks prior to randomization.
• Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
• Subjects with known allergies to more than three substances.
• 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.
• Uncontrolled medical condition.
• 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.
• 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.

Where it is running

• 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
• Augusta Univeristy — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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