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Surgical Site InfectionJumpStartNCT06312267

Reducing Wound Infections Using Bioelectric Wound Dressings

A study testing Bioelectric dressing in people with Surgical Site Infection, run by AdventHealth at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Surgical Site Infection
What is being tested?
Bioelectric dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
4 Mar 2024to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • AdventHealth Celebration

    Kissimmee, Florida, 34747

Other trials in United States

About this study

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.

Read the 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.

Being tested
Bioelectric dressing
Keywords
Surgery outcomes, Bioelectric dressing,
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioelectric dressingDevice

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

Study groups in NCT06312267
Study groupRoleWhat they receive
Control ArmNo interventionStudy participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.
Experimental ArmExperimentalStudy participants will use Bioelectrical dressing preoperatively and post-operative.
Receives: Device: Bioelectric dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative bacterial count

    Skin biopsies will be collected and analyzed for bacterial counts

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start4 Mar 2024
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Total of 20 patients will be identified and divided in two groups (control and experimental group). 10 of the patients undergo surgery using current ERAS protocol standard of care skin cleaning preparation. The other 10 patients skin prep will be substituted with the Bioelectrical dressing preoperatively and post-operative.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312267
Sponsor's protocol ID
1840655
Acronym
JumpStart
Status last verified
Apr 2026
First submitted
7 Mar 2024
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

    PubMed 30426190

  • Cooke CL, Greene RS, van Eck CF, Uquilas C, Limpisvasti O. Bioelectric Silver-Zinc Dressing Equally Effective to Chlorhexidine in Reducing Skin Bacterial Load in Healthy Volunteers. Arthroscopy. 2018 Oct;34(10):2886-2891. doi: 10.1016/j.arthro.2018.05.046. Epub 2018 Sep 5.

    PubMed 30195951

  • Kim H, Park S, Housler G, Marcel V, Cross S, Izadjoo M. An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. Mil Med. 2016 May;181(5 Suppl):184-90. doi: 10.7205/MILMED-D-15-00157.

    PubMed 27168571

  • Banerjee J, Das Ghatak P, Roy S, Khanna S, Hemann C, Deng B, Das A, Zweier JL, Wozniak D, Sen CK. Silver-zinc redox-coupled electroceutical wound dressing disrupts bacterial biofilm. PLoS One. 2015 Mar 24;10(3):e0119531. doi: 10.1371/journal.pone.0119531. eCollection 2015.

    PubMed 25803639

  • Banerjee J, Das Ghatak P, Roy S, Khanna S, Sequin EK, Bellman K, Dickinson BC, Suri P, Subramaniam VV, Chang CJ, Sen CK. Improvement of human keratinocyte migration by a redox active bioelectric dressing. PLoS One. 2014 Mar 3;9(3):e89239. doi: 10.1371/journal.pone.0089239. eCollection 2014.

    PubMed 24595050

  • Barki KG, Das A, Dixith S, Ghatak PD, Mathew-Steiner S, Schwab E, Khanna S, Wozniak DJ, Roy S, Sen CK. Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing. Ann Surg. 2019 Apr;269(4):756-766. doi: 10.1097/SLA.0000000000002504.

    PubMed 29099398

  • Kim H, Makin I, Skiba J, Ho A, Housler G, Stojadinovic A, Izadjoo M. Antibacterial efficacy testing of a bioelectric wound dressing against clinical wound pathogens. Open Microbiol J. 2014 Feb 21;8:15-21. doi: 10.2174/1874285801408010015. eCollection 2014.

    PubMed 24627730

  • Kim H, Izadjoo MJ. Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. J Wound Care. 2015 Feb;24 Suppl 2:S10-4. doi: 10.12968/jowc.2015.24.Sup2.S10.

    PubMed 25647504

  • Kulkarni N, Arulampalam T. Laparoscopic surgery reduces the incidence of surgical site infections compared to the open approach for colorectal procedures: a meta-analysis. Tech Coloproctol. 2020 Oct;24(10):1017-1024. doi: 10.1007/s10151-020-02293-8. Epub 2020 Jul 9.

    PubMed 32648141

  • Hubner M, Diana M, Zanetti G, Eisenring MC, Demartines N, Troillet N. Surgical site infections in colon surgery: the patient, the procedure, the hospital, and the surgeon. Arch Surg. 2011 Nov;146(11):1240-5. doi: 10.1001/archsurg.2011.176. Epub 2011 Jul 18.

    PubMed 21768407

Questions about this trial

What is this clinical trial studying?

A study testing Bioelectric dressing in people with Surgical Site Infection, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312267, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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