D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

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

NCT04233424

Run by

PolyPid Ltd.

People needed

977

Starts

2020-06-24

Expected to finish

2022-09-02

Last updated by the study team

2026-04-21

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 > 10cm (target incision).
• Subjects are preoperative hemodynamically stable
• Male or non-pregnant female.
• Female of child-bearing potential should have a negative pregnancy test 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 60 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, ect.)
• Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
• Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, excluding pre-operative prophylaxis.
• Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
• Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
• Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
• Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics during the past 4 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 3 substances (an allergy questionnaire will be completed during the screening process).
• 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.
• Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
• Subjects with severe hepatic impairment.
• Subjects with chronic urticaria.
• Subjects diagnosed with CVA within the past 6 months prior to randomization.
• 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 3 years.
• Any subject with an active malignancy, other than resectable non-metastatic colorectal cancer, that is the reason for the index surgery, or carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin, or a malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years.
• Subjects with other concurrent severe and/or uncontrolled medical conditions.
• Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
• Chronic alcoholic or drug abuse subjects.
• Pregnant or breast-feeding women or women of child-bearing age who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period.
• Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study.
• Subjects participating in any other interventional study.
• Subjects, who in the opinion of Investigator, are not eligible to participate in the study and/or to comply with the protocol requirements (e.g. due to a cognitive or medical condition).

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Paradigm Clinical Research Center — Redding, California, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Summit Medical Group — Bend, Oregon, United States
• "Multiprofile Hospital for Active Treatment - Blagoevgrad" AD — Blagoevgrad, Bulgaria
• "Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski - 2003" OOD — Dupnitsa, Bulgaria
• "Multiprofile Hospital for Active Treatment - Haskovo" AD — Haskovo, Bulgaria
• "Multiprofile Hospital for Active Treatment - Uni Hospital" OOD — Panagyurishte, Bulgaria
• "MHAT Sveta Caridad" EAD — Plovdiv, Bulgaria
• University First Multiprofile Hospital for Active Treatment - Sofia Sv. Yoan Krastitel EAD — Sofia, Bulgaria
• "IV Multiprofile Hospital for Active Treatment - Sofia" EAD — Sofia, Bulgaria
• "University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov" EAD — Sofia, Bulgaria
• "Multiprofile Regional Hospital for Active Treatment "Dr. St. Cherkezov"" AD — Veliko Tarnovo, Bulgaria
• Complex Oncology Center - Vratsa - EOOD — Vratsa, Bulgaria
• Department - Surgery, "Multiprofile Hospital for Active Treatment - Hristo Botev" AD — Vratsa, Bulgaria
• "Multiprofile Hospital for Active Treatment "Sveti Panteleymon"-Yambol AD — Yambol, Bulgaria
• KBC Rijeka — Rijeka, Croatia
• General Hospital Zadar — Zadar, Croatia
• KBC Sestre milosrdnice Klinika za tumore — Zagreb, Croatia
• University Hospital Centre Zagreb (KBC Rebro) — Zagreb, Croatia
• Fakultni Nemocnice Brno Chirurgicka klinika — Brno, Czechia
• Krajska nemocnice Liberec, a. s. — Liberec, Czechia
• Fakultni nemocnice Kralovske Vinohrady Chirurgicka klinika — Prague, Czechia
• Nemocnice Na Bulovce — Prague, Czechia
• Shoals Medical Trials — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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