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

PolyPid Ltd.0 个研究点目标入组 950 人开始时间: 2020年9月2日最近更新: 2023年1月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: PolyPid Ltd.
入组人数: 950

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 750
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

排除标准

•1. 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.)
•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 anticancer 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 reaction
•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 reopening 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).

研究者

发起方

PolyPid Ltd.

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