Reducing Wound Infections Using Bioelectric Wound Dressings

N/AEnrolling By InvitationNCT06312267

AdventHealth20 enrolled

Overview

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.

The standard of care for enhance recovery after surgery (ERAS) protocol uses chlorhexidine alcohol base prep as the way to clean the skin preoperatively to decrease bacterial flora before sterile prep at the OR. Under ERAS protocol there is no recommendations on any post-operative dressing. Biolelectric wound dressing has been introduced, used and proof to decrease wound infection in orthopedic extremity clean surgery for years. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Surgical Site Infection

Interventions

Bioelectric dressingDEVICE

Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

AdventHealth Celebration

Kissimmee, Florida, United States

Outcomes

Primary Outcomes

Quantitative bacterial count

Skin biopsies will be collected and analyzed for bacterial counts

Time frame: 4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)

Data from ClinicalTrials.gov

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