Surgical Site Infection Clinical Trial
— D-PLEX312Official title:
D-PLEX 312 - Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
Verified date | October 2023 |
Source | PolyPid Ltd. |
Contact | Michal Lavi |
Phone | +972 74-7195700 |
michal.l[@]polypid.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 624 |
Est. completion date | September 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: 1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is >20cm (target incision). 2. Subjects are preoperative hemodynamically stable. (BP=180/110 and >90/60 mmHg, and HR=120 and >60 bpm, and temperature =37.50C 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. 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. Exclusion criteria: 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 colorectal resection. Female sterilization surgeries (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 . 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 and/or pelvis 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 or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years. Excluding: Subjects with potentially resectable non-metastatic colorectal cancer, that is the reason for the index surgery. Subjects who have had carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin. Subjects with any additional non-violent cancer that does not require treatment 4 weeks prior to the surgery, and throughout the entire study duration. 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). |
Country | Name | City | State |
---|---|---|---|
Hungary | Uzsoki utcai Kórház, Sebészeti Osztály | Budapest | |
Hungary | Bács-Kiskun Megyei Kórház | Kecskemét | |
Hungary | Pest Megyei Flór Ferenc Kórház | Kistarcsa | |
Hungary | Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház | Nyíregyháza | |
Hungary | Szegedi Tudományegyetem Általános Orvostudományi Kar Szent-Györgyi Albert Orvostudományi Központ | Szeged | |
Hungary | Szent Borbála Kórház | Tatabánya | |
Israel | Soroka Medical Center | Be'er Sheva | |
Israel | Bnai Zion Medical Center | Haifa | |
Israel | Carmel Medical Center | Haifa | |
Israel | Shaare Zedek MC | Jerusalem | |
Israel | Galil MC | Nahariya | |
Poland | UCK im. Prof. K. Gibinskiego, Oddziat Chirurgii Przewodu Pokarmowego | Katowice | |
Poland | Med.-Gastr Lódz | Lódz | |
Poland | Szpital im. M. Curie-Sklodowskiej w Ostrowie Mazowieckim | Wolomin | |
Poland | Wojewódzki Szpital Specjalistyczny we Wroclawiu | Wroclaw | |
Serbia | Clinical Centre Kragujevac, General and Thoracic Surgery Clinic | Kragujevac | |
Serbia | Clinical Centre Nis, Clinic for Digestive Surgery | Nis | |
Serbia | Institute of Oncology of Vojvodina, Clinic of Operative Oncology | Sremska Kamenica | |
United States | Baylor University Medical Center | Dallas | Texas |
United States | HD Research LLC / Memorial Hermann Southeast Hospital | Houston | Texas |
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
PolyPid Ltd. |
United States, Hungary, Israel, Poland, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control. | Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post abdominal surgery. [abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)].within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee.
All-cause mortality and re-interventions in the target incision within 30 days post index surgery will be analysed as treatment failure. Incisional infection event only, occurred within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee. [abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)]. |
By day 30 post surgery | |
Primary | Safety of D-PLEX in Prevention of Post Abdominal Surgery | Safety parameters will be evaluated by adverse events | By day 60 post surgery | |
Primary | Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional | Incisional wound healing will be assessed by a blinded Investigator, using a visual examination as well as Modified Vancouver Scar Scale wound assessment questionnaires. The questionnaire has a numeric scale from 0-4 in Vascularity, Pigmentation, Pliability and height | By day 60 post surgery | |
Secondary | Assessment of Infection rate in patient undergoing abdominal colon surgery | Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event only, occurred within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee.
[abdominal incisional infection is defined as Deep Incisional Surgical Site Infection (DSSI) and/or Superficial Incisional Surgical Site Infection (SSSI)]. |
At study visits: day 1, day 5, day 14 and day 30 post surgery |
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