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

Trial Summary

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 data supports the idea that Bioelectric Dressing for Wound Infections is an effective treatment?

The available research shows that Bioelectric Dressings, like Procellera, are effective in treating wound infections. One study found that these dressings helped heal complex wounds in small animals within four weeks without infection. Another study showed that Bioelectric Dressings were effective in managing infections and promoting healing in hard-to-heal wounds, with one wound healing completely and others reducing in size. Additionally, a study found that the silver-zinc Bioelectric Dressing was as effective as chlorhexidine, a common antiseptic, in reducing bacteria on the skin. ^{1 2 3 4 5}

What safety data exists for bioelectric wound dressings?

The safety data for bioelectric wound dressings, including Procellera, indicates that they are generally safe for use. A pilot study on a patterned electroceutical dressing (PED) showed little to no visually observable adverse effects on chronic human skin wounds in a small cohort of patients. Additionally, a study on small animal patients with complex wounds treated with a bioelectric dressing reported complete wound closure without infection or adverse effects. These findings suggest that bioelectric dressings are safe for clinical application, though larger studies are recommended to further confirm these results. ^{1 2 3 6 7}

Is the Bioelectric Wound Dressing a promising treatment for wound infections?

Yes, the Bioelectric Wound Dressing is a promising treatment for wound infections. It uses silver and zinc to create a small electric field that helps heal wounds and fight infections without needing an external power source. Studies show it can effectively manage infections, promote healing, and is as effective as other treatments in reducing bacteria. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Jay Redan, MD

Principal Investigator

AdventHealth

Eligibility Criteria

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

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

Treatment Details

Interventions

• Bioelectric Wound Dressing

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An Overview of the Efficacy of a Next Generation Electroceutical Wound Care Device. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Antibiofilm efficacy evaluation of a bioelectric dressing in mono- and multi-species biofilms. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Bioelectric Dressing Supports Complex Wound Healing in Small Animal Patients. [2018]

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Bioelectric Silver-Zinc Dressing Equally Effective to Chlorhexidine in Reducing Skin Bacterial Load in Healthy Volunteers. [2019]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Disposable Patterned Electroceutical Dressing (PED-10) Is Safe for Treatment of Open Clinical Chronic Wounds. [2020]