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).
- 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
- 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.
Screening Visit (Visit 1):
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.