Evaluation of efficacy and safety of D-PLEX in prevention of post abdominal surgery incisional infection.
- Conditions
- Prevention of post abdominal surgery incisional infectionMedDRA version: 20.0Level: LLTClassification code 10078408Term: Surgical site infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-002325-28-BG
- Lead Sponsor
- PolyPid Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1400
1. 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).
2. Subjects are preoperative hemodynamically stable (BP =180/110 and
=90/60 mmHg, and HR =100 and =60 bpm, and temperature =38.50C
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.
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 (see Section 8.6 CONTRACEPTIVE METHODS).
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 60 days post randomization
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
1. Subjects with suspected/diagnosed intestinal perforation, intraabdominal abscess, or any emergency/urgent colorectal surgery with
acute intestinal obstruction (ex. toxic colitis, ileus/sub-ileus, megacolon,
diverticulitis, volvulus, ect.)
2. Subjects who underwent an intra abdominal surgery within the last 6
months prior to randomization.
3. 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.
4. Subjects undergoing concomitant major procedures in addition to the
abdominal surgery, including concomitant repair of ventral hernia.
Salpingo oophorectomy and cholecystectomy are allowed.
5. Subjects who received any anti cancer treatment within the last 4
weeks of surgery.
6. Subjects who received radiation for colorectal cancer to the abdomen
area, prior to the planned abdominal surgery.
7. Subjects who received oral or IV Doxycycline or Tetracycline family
antibiotics during the past 4 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 3 substances (an allergy
questionnaire will be completed during the screening process).
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. Subjects with End Stage Renal Disease (ESRD/ CKD stage 5).
12. Subjects with severe hepatic impairment.
13. Subjects with chronic urticaria.
14. Subjects diagnosed with CVA within the past 6 months prior to
randomization.
15. 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.
16. 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.
17. Subjects with other concurrent severe and/or uncontrolled medical
condition.
18. Psychiatric or any other disorder that compromises ability to provide
informed consent for participation in this study.
19. Chronic alcoholic or drug abuse subjects.
20. 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.
21. 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.
22. Subjects participating in any other interventional study.
23. 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method