Bioelectric Dressing for Wound Infections

(JumpStart Trial)

Overseen By Diana Paredes, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Must not be taking: Antibiotics, Chemotherapy, Steroids

Disqualifiers: Active infections, Immunosuppression, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for wound care during colon surgery. Researchers aim to determine if a bioelectric dressing, which uses electrical fields, is more effective than the usual skin cleaning method when applied before and after surgery. The goal is to reduce infections and enhance healing. Eligible participants are those planning elective colon surgery and can follow specific wound dressing care instructions. As an unphased trial, this study allows patients to contribute to innovative wound care research.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking antibiotics for more than 2 weeks before surgery. Other medications are not specified, so you may need to discuss with the trial team.

What prior data suggests that the Bioelectric Wound Dressing is safe for wound infections?

Research has shown that bioelectric wound dressings, such as Procellera, are generally safe. A small study found these dressings to be safe, helping to reduce infections and support healing through a tiny electrical charge. The FDA has approved this technology for various wounds, including pressure sores and diabetic ulcers. Most users tolerate these dressings well, with no major reports of serious side effects. Additionally, the dressings allow for easy movement, benefiting active patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bioelectric Wound Dressing is unique because it uses electrical stimulation to promote healing and fight infections. Unlike traditional wound care, which often relies on topical antibiotics or antiseptics, this dressing generates a mild electrical field that can disrupt bacterial growth and enhance tissue regeneration. Researchers are excited about this treatment because it offers a non-invasive, drug-free approach that may accelerate healing and reduce the risk of infection, providing a promising alternative to standard care methods.

What evidence suggests that the Bioelectric Wound Dressing is effective for wound infections?

Research has shown that bioelectric wound dressings, which participants in this trial may receive, effectively reduce infections caused by bacteria. One study found that these dressings significantly decreased the severity of bacterial infections compared to regular treatments, suggesting they can combat bacteria that often cause wound infections. Another study demonstrated that bioelectric dressings helped heal complex wounds in small animals within four weeks without infection. Additionally, bioelectric technology has proven effective in preventing and reducing infections in burn wounds. These findings suggest that bioelectric wound dressings can be a powerful tool in managing wound infections. ^{3 6 7 8 9}

Who Is on the Research Team?

Jay Redan, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

Inclusion Criteria

Ability to provide informed consent

I received only one dose of antibiotics before surgery.

I have undergone a bowel preparation process.

Exclusion Criteria

BMI >40

Pregnancy or lactating women

Inability to take intestinal bowel preparation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive Bioelectric wound dressing on the pre-operative wound site

3 days

1 visit (in-person)

Surgery and Immediate Post-operative Treatment

Participants undergo surgery and receive Bioelectric wound dressing post-operatively

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for wound infection and bacterial count post-surgery

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioelectric Wound Dressing

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Study participants will use Bioelectrical dressing preoperatively and post-operative.

Group II: Control Arm Active Control 1 Intervention

Study participants will undergo surgery using current ERAS protocol standard of care skin cleaning preparation.

Bioelectric Wound Dressing is already approved in United States for the following indications:

Approved in United States as Procellera for:

• Partial and full-thickness wounds
• Pressure ulcers
• Venous ulcers
• Diabetic ulcers
• Burns
• Surgical incisions
• Graft sites

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Published Research Related to This Trial

The study involved 48 healthy volunteers and compared the effectiveness of a silver-zinc bioelectric dressing with 2% and 4% chlorhexidine in reducing bacterial counts on the knee, showing that all methods significantly reduced bacterial growth compared to unprepped knees.

The silver-zinc bioelectric dressing was found to be equally effective as both concentrations of chlorhexidine in reducing skin bacterial load, suggesting it can be a viable alternative to traditional antiseptic skin preparation before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioelectric Silver-Zinc Dressing Equally Effective to Chlorhexidine in Reducing Skin Bacterial Load in Healthy Volunteers. Cooke, CL., Greene, RS., van Eck, CF., et al.[2019]

A microcell battery-impregnated bioelectric dressing (BED) was used on 5 small animal patients with complex wounds, and all wounds achieved complete closure within 4 weeks without infection or the need for grafting.

The BED not only supports wound healing but also provides a nonantibiotic antimicrobial effect, suggesting it could be a valuable tool in veterinary wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioelectric Dressing Supports Complex Wound Healing in Small Animal Patients. Maijer, A., Gessner, A., Trumpatori, B., et al.[2018]

Bioelectric dressings were effective in promoting healing in hard-to-heal wounds, as demonstrated in a case report involving five patients, four with diabetic foot ulcers and one with a surgical site infection.

Out of the five wounds treated, one healed completely, while the others showed significant size reduction and improved tissue regeneration, indicating the potential of bioelectric dressings in wound management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of bioelectric dressings for patients with hard-to-heal wounds: a case report. Nair, HK., Yan, TD.[2023]

The study evaluated the antibiofilm properties of a silver and zinc bioelectric dressing (Procellera) using a custom poloxamer biofilm model, showing significant inhibition of bacterial growth in nine pathogens, with reductions of approximately 2- to 3-fold log10 compared to controls.

The bioelectric dressing demonstrated effective antibiofilm activity against both single and polymicrobial biofilms, indicating its potential as a treatment for chronic infections that are difficult to manage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. Kim, H., Izadjoo, MJ.[2019]

In a study involving 80 US Army Ranger recruits, the bioelectric dressing Procellera® did not show a significant improvement in the healing rate of blisters compared to standard-of-care treatments like moleskin and Tegaderm® over a 2-week period.

Both treatment groups experienced low pain levels, indicating that the blisters were mild, and there was no statistical difference in pain between the Procellera and standard treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits. Housler, GJ., Cross, S., Marcel, V., et al.[2022]

Procellera is a novel wound care device that generates a microelectric potential (0.5-0.9 Volts) using a matrix of silver and zinc, which enhances wound healing without needing an external power source.

The device has shown efficacy against both planktonic and biofilm forms of wound pathogens, including multidrug-resistant organisms, making it a promising option for controlling infections in clinical and field settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. Kim, H., Park, S., Housler, G., et al.[2018]

A pilot study involving 8 patients with chronic wounds showed that the patterned electroceutical dressing (PED) was safe for use, with little to no observable adverse effects on the skin and wound tissue during treatment before amputation surgery.

The PED, designed to deliver regulated electrical currents to wounds, represents an innovative approach that could potentially treat deeper infections more effectively than current surface-level wound care methods, suggesting a need for further research on its clinical impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disposable Patterned Electroceutical Dressing (PED-10) Is Safe for Treatment of Open Clinical Chronic Wounds. Roy, S., Prakash, S., Mathew-Steiner, SS., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10654645/

A Prospective, Randomized, Controlled Study to Evaluate ... Primary outcome was to show that significantly higher percentage of WED-treated samples showed decreased biofilm severity compared with SoC treatment measured ...

2. vomaris.com vomaris.com/study-finds-vomaris-bioelectric-technology-significantly-decreased-biofilms-in-burn-patients/

Study Finds Vomaris Bioelectric Technology Significantly ... Dox™ Technology was effective in preventing and reducing biofilm infection in burn wounds. The manuscript, “A Prospective, Randomized ...

3. academic.oup.com academic.oup.com/milmed/article/181/suppl_5/184/4209468

Overview of the Efficacy of a Next Generation Electroceutical ... The research presented herein describes efficacy evaluation of a wireless bioelectric dressing against both planktonic and biofilm forms of wound pathogens.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01061502

Efficacy Study of a Bioelectric Dressing to Treat Skin Graft ... The purpose of this study is to determine whether the use of a bioelectric wound dressing is effective in the healing of skin graft donor site wounds. Official ...

5. withpower.com withpower.com/trial/phase-infections-2-2024-da2db

Bioelectric Dressing for Wound Infections (JumpStart Trial) One study found that these dressings helped heal complex wounds in small animals within four weeks without infection. Another study showed that Bioelectric ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3950956/

Antibacterial Efficacy Testing of a Bioelectric Wound ... In this study we examined in vitro antibacterial efficacy of a bioelectric dressing containing silver and zinc against various wound pathogens.

7. vomaris.com vomaris.com/

Vomaris - Bioelectric Technology For Antimicrobial Wound ... Reduce the risk of infection and support wound healing with a bioelectric wound dressing. Inspired by the body. Powered by electricity. Energized by results.

8. mms.mckesson.com mms.mckesson.com/product/707049/Vomaris-Wound-Care-VSR-0202-10

Bioelectric Dressing Procellera™ 2 X 2 Inch Square Sterile Water resistant self-stick antibacterial composite dressings absorb excess wound drainage and enable maximum mobility. More Information. SDS. Frequently Viewed ...

9. ambuusa.com ambuusa.com/Admin/Public/Download.aspx?file=Files%2FFiles%2FDownloads%2FAmbu+USA%2FAnesthesia%2FRegional_Anesthesia%2FProcellera+Antimicrobial+Wound+Dressing%2FSupplementary+Information%2FProcellera_Technical_Summary_Okt_2010-5837.pdf

CMB Antimicrobial Wound Dressing is a novel bioelectrical ... PROCELLERATM Antimicrobial Dressing is FDA cleared for professional use for partial and full- thickness wounds such as: pressure ulcers, venous ulcers, diabetic ...