D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

Inclusion Criteria

• Subjects undergoing elective abdominal colon surgery involving resection and ileocolonic, ileorectal, colocolonic or colorectal anastomosis or with a stoma, who are preoperative stable hemodynamically. In a laparoscopic surgery, an abdominal wall incision ≥ 5 cm should be involved.
• Male or non-pregnant female.
• Females of childbearing potential should have a negative serum pregnancy test prior to index procedure. All females of childbearing potential must agree to use a highly effective method of contraception (e.g., double barrier, oral or parenteral hormonal, intrauterine device, or spermicide) consistently and correctly for the duration of the study.
• Age ≥ 18 years old at screening.
• Subjects who signed a written informed consent.
• Willing and able to participate and meet all study requirements.
• Survival expectancy of at least 60 days post randomization.

Exclusion Criteria

• Subjects scheduled for abdominal surgery which is classified as emergency.
• Subjects with any preoperative active infection that is currently being treated with antibiotics.
• Subjects receiving any antibiotic therapy in the past 4 weeks prior to enrollment other than prophylaxis or antibiotic for the treatment of the disease for which the surgery is indicated.
• Subjects undergoing concomitant additional procedures other than colon resection surgery (e.g., hyper-thermic intraperitoneal chemotherapy, liver resection, etc.).

Female sterilization surgery (e.g., salpingo-oophorectomy, hysterectomy, etc.), involvement of a small bowel procedure, or cholecystectomy may be allowed, pending an advanced consultation and approval from the sponsor.

• Subject received chemotherapy within the past 4 weeks of surgery, or radiation for colorectal cancer to the abdominal area, prior to the planned abdominal surgery (neo-adjuvant treatment).
• Subjects that received oral or IV doxycycline during the past 4 weeks prior to screening.
• Subjects with known hypersensitivity to doxycycline and/or to the tetracycline family of drugs or to the D-PLEX excipients.
• Subjects with known allergies to more than 3 substances (as determined from allergy questionnaire at screening).
• Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intravenous steroids/intramuscular epinephrine or in the opinion of the investigator the subject is at high risk of developing severe allergic/hypersensitivity reactions.
• Subjects with uncontrolled asthma (GINA III-IV).
• Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
• Subjects with chronic urticaria.
• Subjects diagnosed with TIA/CVA/ACS within the past 1 year prior to randomization.
• Subjects that have undergone any prior abdominal surgery and current planned surgery involves re-opening the scar of the prior abdominal surgery.
• Any subject with an active malignancy or malignancy that has not been in complete remission for at least 5 years. Excluding:
• Subjects with potentially resectable non-metastatic colorectal cancer for which the surgery is indicated.
• Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin, and basal cell carcinoma of the skin.
• Subjects with non-violent cancer that does not require treatment 4 weeks prior to, and throughout the entire study duration.
• Subjects with other concurrent severe and/or uncontrolled medical condition that could compromise participation in the study (e.g., non-GI active infection, uncontrolled diabetes, uncontrolled hypertension, congestive heart failure, unstable angina, ventricular arrhythmias, active ischemic heart disease, uncompensated cirrhosis, active upper GI tract ulceration).
• Psychiatric, addictive, or any other disorder that compromises ability to provide informed consent for participation in this study.
• Chronic alcohol or drug abuse.
• Pregnant or breast-feeding women or women of chi