Reducing Wound Infections Using Bioelectric Wound Dressings

Not Applicable

Recruiting

• Conditions: Surgical Site Infection
• Interventions: Device: Bioelectric dressing

• Registration Number: NCT06312267
• Lead Sponsor: AdventHealth

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-04
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Bioelectric dressing	Study participants will use Bioelectrical dressing preoperatively and post-operative.

Primary Outcome Measures

Name	Time	Method
Quantitative bacterial count	4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)	Skin biopsies will be collected and analyzed for bacterial counts

Trial Locations

Locations (1)

AdventHealth Celebration; 🇺🇸 Kissimmee, Florida, United States