Last updated on January 2014

Triple IN Study (Inhibition of Incisional Infections): Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections among Colorectal Surgery Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rectal Cancer | Colon Cancer
  • Age: 18 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Scheduled to undergo elective colon and/or rectal surgical procedures involving an open incision of 7 cm in length or greater. Eligible surgeries include left hemicolectomy, right hemicolectomy, transverse colectomy, ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total abdominal proctocolectomy, low anterior resection, sigmoid resection, nonemergent Hartmann procedure, colostomy takedown through laparotomy incision, ileo-pouch anal anastomosis, and abdominal perineal resection of the rectum.
  • Able to give informed consent.
  • Male or female ≥18 years of age.
  • If female, is non-pregnant and non-lactating.
  • If female, is either not of childbearing potential or practicing acceptable methods of birth control and agrees to continue over the study surveillance period
  • Agreement to be available for evaluation at the study site for scheduled visits.

Exclusion Criteria:

  • Hypersensitivity to porcine products.
  • History of known anti-myeloperoxidase autoantibodies (i.e., p-ANCA), as well as patients with known idiopathic necrotizing glomerulonephritis and certain systemic vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels, Wegener’s granulomatosis, and Churg-Strauss Syndrome]).
  • Absolute contraindication to general anesthesia.
  • Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or sutures.
  • History of hypertrophic scarring after surgery or keloid formation after skin abrasions/cuts.
  • Subjects diagnosed with collagen vascular disease, including scleroderma.
  • Body mass index >40.
  • ASA score >3.
  • Undergoing a significant additional surgical procedure (e.g., hysterectomy) or any mesh repair as part of closure.
  • Preoperative severe neutropenia (total neutrophil count ≤500 X 106/L).
  • Current abdominal wall infection/surgical site infection secondary to previous laparotomy/laparoscopy or from any other cause.
  • Receiving any oral or intravenous antibiotics within 1 week prior to the date of planned procedure. Prophylactic antibiotics for dental or other brief procedures are acceptable.
  • History of chemotherapy within prior 2 weeks or radiation therapy within prior 6 weeks.
  • History of major organ transplantation, including bone marrow transplantation.
  • History of laparotomy within 60 days prior to planned procedure.
  • Planning to undergo a second laparotomy or colorectal surgical procedure within 60 days of planned procedure.
  • Preoperative prothrombin time or INR > 2 x upper limit of normal.
  • Taking systemic steroids >20 mg prednisone daily, infliximab (Remicade®), or other anti-inflammatory/immunosuppressive medication within 2 weeks prior to surgery or a history of a current immunosuppressive condition.
  • Refusal to accept medically indicated blood products.
  • Presence of prosthetic cardiac valve(s).
  • Patients with severe COPD that are likely to need more than 24 hours postoperative ventilator support.
  • Patients with pre-operative bacteriuria of ≥104 bacteria/mL urine and/or positive leucocyte esterase and/or nitrite urine dipstick tests.
  • Patients with a condition (e.g., nail infections, sinusitis, dental infections, vaginitis/vaginosis, chronic bronchitis) requiring frequent or chronic administration of antimicrobials (received antimicrobials at least twice for ≥ 2 weeks during past 6 months).
  • Anticipated non-availability for study visits/procedures.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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