D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

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 > 10cm (target incision).
• Subjects are preoperative hemodynamically stable
• Male or non-pregnant female.
• Female of child-bearing potential should have a negative pregnancy test prior to index procedure.
• 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/sub-ileus, megacolon, diverticulitis, volvulus, ect.)
• Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
• 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.
• Subjects undergoing concomitant major procedures in addition to the abdominal surgery, including concomitant repair of ventral hernia. Salpingo-oophorectomy and cholecystectomy are allowed.
• Subjects who received any anti-cancer treatment within the last 4 weeks of surgery.
• Subjects who received radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.
• Subjects who received oral or IV Doxycycline or Tetracycline family antibiotics 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 (an allergy questionnaire will be completed during the screening process).
• 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 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.
• 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.
• Subjects with other concurrent severe and/or uncontrolled medical conditions.
• Psychiatric or any other disorder that compromises ability to provide informed consent for participation in this study.
• Chronic alcoholic or drug abuse subjects.
• 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 study.
• 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).