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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PolyPid Ltd.

Criteria

Inclusion Criteria:

1. Subjects undergoing a colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 incision that is ≥ 7cm (target incision).

2. Subjects are preoperative hemodynamically stable.

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. Note: All female subjects of child-bearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study.

5. Subjects age 18 years old and above at screening.

6. Subjects who sign a written Informed Consent Form.

7. Subjects who are willing and able to participate and meet all study requirements.

8. Survival expectancy of at least 60 days post randomization.

Exclusion Criteria:

1. Subjects with any preoperative infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization, besides prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.

2. Subjects undergoing concomitant additional major procedures besides abdominal surgery. Female sterilization surgery (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.

3. Subject received anti-cancer treatment within the last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.

4. Subjects that received oral or IV Doxycycline/Tetracycline family antibiotic during the past 4 weeks prior to randomization.

5. Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.

6. Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled in during the screening process).

7. Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or in the opinion of the Investigator the subject is at high risk of developing severe allergic reactions.

8. Subjects with End Stage Renal Disease (ESRD/CKD stage 5).

9. Subjects with chronic urticaria.

10. Subjects diagnosed with CVA within the past 6 months prior to randomization.

11. Subjects that undergone any abdominal surgery and current planned surgery involves re-opening the scar of a prior abdominal surgery performed within the last 5 years.

12. Any subject with active malignancy or with malignancy that has not been in complete remission for at least 3 years. Excluding:

• Subjects with potentially resectable non-metastatic cancer which consists of the indication for the surgery.

• Subjects who have had carcinoma in situ (or other cancer "in situ = Stage 0"), squamous cell carcinoma of the skin and basal cell carcinoma of the skin.

• Subjects with any additional non-violent cancer (slowly growing, localized or chronic cancers), that does not require treatment 4 weeks prior to the surgery, and throughout the entire study duration.

13. Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study.

14. Psychiatric or any other disorder that compromises ability to provide Informed Consent Form for participation in this study.

15. Chronic alcoholic or drug abuse subjects.

16. Pregnant or breast-feeding women or women of child-bearing age who refuse or prohibited of using an effective contraceptive method of birth control throughout study participation, including safety follow-up period.

17. Subjects that received any investigational drug within 30 days or 5 half-lives of randomization to the study (whichever is longer).

18. Subjects participating in any other interventional studies.

19. In the opinion of Investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g. due to a cognitive or medical condition).