D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

The aim of this study is to assess the anti‐infective efficacy of D‐PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection in the target incision, compared to the SoC treated control arm, while assessing the safety of D‐PLEX administered concomitantly with the Standard of Care (SoC).

Inclusion Criteria

• Subjects undergoing a colorectal surgery involving resection, with or without a stoma formation, that includes 1 incision that is > 10cm (target incision).
• Subjects are preoperative hemodynamically stable.
• Survival expectancy of at least 60 days post randomization

Exclusion Criteria

• Subjects with any preoperative active infection or who are receiving any antibiotic therapy in the past 1 week prior to randomization besides pre‐operative prophylaxis or antibiotic for the treatment of the disease that consists the indication for surgery.
• Subjects undergoing concomitant additional major procedures besides abdominal surgery. 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 received anti‐cancer treatment within the last 4 weeks of surgery, or radiation for colorectal cancer to the abdomen area, prior to the planned abdominal surgery.

Study Requirements

Screening Visit (Visit 1):

• You will have a physical examination including the measurement of height, weight, and vital signs, such as blood pressure, heart rate, and temperature.
• Your medical history and current medicines will be reviewed; the study doctor or study staff will ask you about your medical history and all medications (prescription and over the counter) that you are currently taking. A Charlson Comorbidity Index questionnaire will be completed based on that information.
• Allergy questionnaire will be reviewed to see if you have any allergies now, or previously had an allergic reaction.
• About half a tablespoon of blood and a cup of urine will be collected for routine laboratory tests.
• If you are a woman of childbearing potential, a pregnancy test to rule out pregnancy will be performed

  Expect the appointment to go about an hour.

  Surgery (Index Procedure, Visit 2):
  
• Your surgeon will explain the operation you are going to have.If you have been randomized to receive D-PLEX, it will be given as an add on to the standard care (which is the treatment that patients with similar conditions are receiving).
• At the time of the surgical procedure, the study doctor will analyze again your qualification or incompatibility for the study and will ultimately approve or disapprove your participation. If you will not be eligible you will not be able to participate in the study and you will not undertake any further study procedures.
• Towards the end of the surgery, if you were randomly assigned to be given the study drug, it will be applied directly onto the surgical incision area, before the surgeon closes your wound.

Usually the duration of the hospitalization period is approximately 4-10 days depending on the method of the surgery. In some cases, your hospital stay may be longer depending on your medical condition.

Follow-up visits (Visits 3-7):

Post-operative care will be performed based on your medical condition and per the standard practice and the recommendation of your surgeon.

The subsequent follow-up visits (visits 3-7) will take place at Day 1, Day 5, Day 14, Day 30, and Day 60 post-surgery. Visits 3-5 are usually performed after this type of surgery, while the additional follow-up visits (visit 6 & 7), required by the study, will be done in addition to the routine visits usually performed after this kind of surgery. Expect these follow-up visits to take at least an hour.

During all of the above-mentioned visits, the following procedures will be performed:

• Vital signs
• Assessment of surgical site wound healing – Including visual examination and wound assessment questionnaires
• Blood tests (half a tablespoon collected each time)
• Urinalysis will be performed only if your study doctor thinks it is necessary
• Adverse Events assessment and recording
• Concomitant Medication Review
• Physical examination [at visits 6 (D30) and 7 (D60)]
• Bacteriology cultures will be taken if there is a suspicion for a wound infection and there is discharge
• Photograph of the incisional wound in case of a suspected infection

In cases where a visit to the Medical Center is not possible, information related to your safety and wound assessment will be obtained in a phone conversation with you, your first degree relative or your community physician.