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 1

Recruiting

• Conditions: Prevention of post abdominal surgery incisional infection.; MedDRA version: 20.0Level: LLTClassification code: 10078408Term: Surgical site infection Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-509698-21-00
• Lead Sponsor: Polypid Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1337

Inclusion Criteria

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)., Subjects are preoperative hemodynamically stable (BP=180/12 and =90/60 mmHg, and HR=120 and =60 bpm, and temperature =37.5°C and =35.5°C)., Male or non-pregnant female., 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)., Subjects’ age 18 years old and above at screening., Subjects who sign the written Informed Consent Form., Subjects who are willing and able to participate and meet all study requirements., Survival expectancy of at least 60 days post randomization.

Exclusion Criteria

Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (ex. toxic colitis, ileus/subileus, megacolon, diverticulitis, volvulus, etc)., 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., Subjects with End Stage Renal Disease (ESRD/CKD stage 5)., Subjects with severe hepatic impairment., Subjects with chronic urticaria., Subjects diagnosed with CVA within the past 6 months prior to randomization., Subjects that undergone any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years., 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 with 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., Subjects with other concurrent severe and/or uncontrolled medical condition., Psychiatric or any other disorder that compromises the ability to provide Informed Consent Form for participation in this study., Chronic alcoholic or drug abuse subjects., Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization., 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., 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., Subjects participating in any other interventional studies., Subjects who in the opinion of Investigator are not eligible to participate in the study and/or to comply with protocol requirements (e.g., due to a cognitive or medical condition)., Subjects with any preoperative infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxis or antibiotics for the treatment of the disease that is the indication for surgery., 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., Subject who received any anti-cancer treatment within the last 4 weeks of surgery, Subjects who received radiation for colorectal cancer to the abdomen and/or pelvis area, prior to the planned abdominal surgery., Subjects who received oral or IV Doxycycline/Tetracycline family antibiotic during the past 4 weeks prior to randomization., Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients., Subjects with known allergies to more than 3 substances

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified