Reducing Wound Infections Using Bioelectric Wound Dressings (JumpStart)

April 23, 2026 updated by: AdventHealth
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Kissimmee, Florida, United States, 34747
        • AdventHealth Celebration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.
Experimental: Experimental Arm
Study participants will use Bioelectrical dressing preoperatively and post-operative.
Device: Bioelectric dressing
Participants randomized into the experimental arm will have a bioelectric dressing applied 3 days before surgery, and 3 days post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative bacterial count
Time Frame: 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
4 total biopsies will be collected. (3 days before surgery, surgery day pre incision, immediately post-surgery and 3 days post-surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Jay Redan, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

March 4, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1840655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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