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OpenTrials
Enrolling by Invitation

NCT Number: NCT06312267

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.

Enrolling by Invitation

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth Celebration

Kissimmee, Florida, 34747, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections
  • Inability to take intestinal bowel preparation
  • HgbA1c >8
  • BMI >40
  • Immunosuppression
  • Need of steroid stress dose pre-op
  • Patient receiving active chemotherapy
  • Need of stoma (end ostomies after resection protective stoma included)
  • Need of blood transfusion during surgery
  • Use of irrigation with antibiotics or IRRISEPTR during surgery
  • Any standard contraindication to anesthesia and/or surgery
  • Pregnancy or lactating women
  • Inability to provide informed consent
  • Inability to follow instructions for dressing care
  • Sensitivity or allergy to silver or zinc

Treatment and study plan

Bioelectric dressing

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Acronym: JumpStart

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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