Overview

D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

Status:
Completed
Trial end date:
2019-10-06
Target enrollment:
0
Participant gender:
All
Summary
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care (SOC). The other half will receive the Standard of Care treatment. Following the surgery subjects will be followed up for additional 5 visits, at least half are in line with the routine practice of surgery Follow-Ups. Visits will include patient safety and wound assessments.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PolyPid Ltd.
Criteria
Inclusion Criteria:

1. Subjects undergoing elective abdominal colon surgery involving resection and
anastomosis or a stoma.

2. Male or non-pregnant female Female of childbearing potential should have a negative
serum pregnancy test prior to index procedure and agree to use a highly effective
method of contraception consistently and correctly for the duration of the study.

3. Subjects who sign a written informed consent

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

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

Exclusion Criteria:

1. Subjects scheduled for abdominal surgery which is classified as emergency.

2. Subjects with any preoperative active infection that is currently being treated with
antibiotics.

3. Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrolment
besides prophylaxis or antibiotic for the treatment of the disease that consists the
indication for surgery.

4. Patients undergoing concomitant additional procedures besides colon resection surgery,
e.g. Hyper-thermic Intraperitoneal Chemotherapy, liver resection etc. Female
sterilization surgery (i.e. salpingo-oophorectomy, hysterectomy etc.), or involvement
of a small bowel procedure or Cholecystectomy may be allowed, pending an advanced
consultation and approval from the sponsor.

5. Subject received chemotherapy within the last 4 weeks of surgery, or radiation for
colorectal cancer to the abdomen area, prior to the planned abdominal surgery (neo-
adjuvant treatment).

6. Subjects that received oral or IV doxycycline during the past 4 weeks prior to
screening.

7. Subjects with known sensitivity to doxycycline and/or to the tetracycline family of
drugs or to the D-PLEX's excipients.

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

9. Subjects with a history of allergic/hypersensitivity reaction to any substance having
required hospitalization and/or treatment with intravenous steroids/intramuscular
epinephrine or in the opinion of the investigator the patient is at high risk of
developing severe allergic/hypersensitivity reactions.

10. Subjects with uncontrolled Asthma (GINA III-IV).

11. Subjects with End Stage Renal Disease [Chronic Kidney Disease (CKD) stage 5].

12. Subjects with chronic urticaria.

13. Subjects diagnosed with severe neurological/cardiac events within the past 1 year
prior to randomization.

14. Subjects that undergone any abdominal surgery and current planned surgery involves
re-opening the scar of prior abdominal surgery.

15. Any subject with active malignancy or with malignancy that has not been in complete
remission for at least 5 years.

Excluding:

- subjects with potentially resectable non-metastatic colorectal cancer which
consists the indication for surgery. In addition,

- patients Patients who have had carcinoma in situ of the cervix, squamous cell
carcinoma of the skin and basal cell carcinoma of the skin

- Non-violent cancer that does not require treatment 4 weeks prior to, and
throughout the entire study duration will be eligible.

16. Subjects with other concurrent severe and/or uncontrolled medical condition that could
compromise participation in the study (e.g. non-GI active infection, uncontrolled
diabetes, uncontrolled hypertension, congestive heart failure, unstable angina,
ventricular arrhythmias, active ischemic heart disease, uncompensated cirrhosis,
active upper gastrointestinal (GI) tract ulceration).

17. Psychiatric, addictive, or any other disorder that compromises ability to provide
informed consent for participation in this study.

18. Chronic alcoholic or drug abuse subjects.

19. Pregnant or breast-feeding women or women of childbearing age who refuse or prohibited
of using an effective contraceptive method of birth control (such as double barrier,
oral or parenteral hormonal, intrauterine device and spermicide) throughout study
participation including safety follow-up period.

20. Subjects that received any investigational drug within 30 days or 5½ half-lives of
enrollment to the study (whichever is longer).

21. Subjects participating in any other interventional studies.

22. 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).