Reducing Wound Infections Using Bioelectric Wound Dressings
The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.
Conditions:
🦠 Surgical Site Infection
🗓️ Study Start (Actual) 4 March 2024
🗓️ Primary Completion (Estimated) 1 December 2024
✅ Study Completion (Estimated) 1 March 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Kissimmee, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Elective diverticular, benign polyp, or colon cancer resection
    • 2. Age 18-90 years old
    • 3. All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc....)
    • 4. Must be off antibiotics for more than 2 weeks before surgery
    • 5. Surgery must be laparoscopic, hand assisted or Robotic
    • 6. Skin will be closed in layers and subcuticular interrupted fashion
    • 7. Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)
    • 8. Patients will have a primary anastomosis, no colostomy.
    • 9. Patient must be compliant with dressing care
    • 10. Ability to provide informed consent

    Exclusion Criteria:

    • 1. Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections
    • 2. Inability to take intestinal bowel preparation
    • 3. HgbA1c \>8
    • 4. BMI \>40
    • 5. Immunosuppression
    • 6. Need of steroid stress dose pre-op
    • 7. Patient receiving active chemotherapy
    • 8. Need of stoma (end ostomies after resection protective stoma included)
    • 9. Need of blood transfusion during surgery
    • 10. Use of irrigation with antibiotics or IRRISEPTR during surgery
    • 11. Any standard contraindication to anesthesia and/or surgery
    • 12. Pregnancy or lactating women
    • 13. Inability to provide informed consent
    • 14. Inability to follow instructions for dressing care
    • 15. Sensitivity or allergy to silver or zinc
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 March 2024
  • First Submitted that Met QC Criteria 13 March 2024
  • First Posted 15 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 March 2024
  • Last Update Posted 15 March 2024
  • Last Verified March 2024