Using bioelectric dressings to reduce surgical wound infections

Reducing Wound Infections Using Bioelectric Wound Dressings

This study is testing if special bioelectric dressings can help prevent infections in patients having elective surgeries, compared to the usual skin cleaning methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: AdventHealth (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Kissimmee, Florida)
• Trial ID: NCT06312267 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of bioelectric wound dressings compared to standard chlorhexidine skin preparation in preventing surgical site infections. It focuses on patients undergoing elective surgeries such as diverticular, benign polyp, or colon cancer resections. Participants will receive bioelectric dressings on their wounds both pre-operatively and post-operatively, while their outcomes will be compared to those receiving standard care. The study is part of an enhanced recovery after surgery (ERAS) protocol, which seeks to optimize surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 undergoing elective laparoscopic, hand-assisted, or robotic surgeries for diverticular disease, benign polyps, or colon cancer.

Not a fit: Patients with active infections, severe obesity (BMI > 40), or those on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of surgical site infections, leading to improved recovery and outcomes for patients.

How similar studies have performed: Previous studies have shown that bioelectric dressings can effectively reduce wound infections in orthopedic surgeries, suggesting potential success in this novel application.

Eligibility criteria

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

Where this trial is running

Kissimmee, Florida

• AdventHealth Celebration — Kissimmee, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Jay Redan, MD — AdventHealth
• Study coordinator: Petronio Martins, MHA

Conditions: Surgical Site Infection, Surgery outcomes, Bioelectric dressing,