Antimicrobial Wound Gel for Surgical Site Complications

No longer recruiting at 2 trial locations

Overseen By Meriton Ruhani

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Disqualifiers: Allergy to study products, Mental impairment, Vulnerable population, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special antimicrobial gel, SurgX, to determine if it can reduce complications after hip or knee replacement surgeries. Researchers aim to discover if this gel improves wound healing by reducing harmful germs. The trial compares two groups: one uses the SurgX gel, and the other follows standard care (also known as Standard Treatment, Conventional Care, or Usual Care). Individuals scheduled for a hip or knee replacement who can adhere to the study steps might be suitable candidates. As an unphased trial, this study allows patients to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SurgX Antimicrobial Wound Gel targets bacteria in surgical wounds by breaking down biofilms, the protective layers of bacteria. Studies have found that SurgX can reduce bacteria in surgical areas, potentially lowering infection risk.

However, one study found that SurgX did not significantly reduce minor infection rates in joint surgeries. This suggests that while the gel targets bacteria, it might not always prevent visible infections.

Regarding safety, specific information about side effects in humans is not available from the sources. Since the trial is in the "Not Applicable" phase, it likely remains in early testing, meaning safety data might still be limited. The gel aims to fight bacteria without causing harm, and no major safety issues have been reported so far. Discussing potential risks with the trial team before joining is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SurgX Antimicrobial Wound Gel because it offers a novel approach to preventing surgical site complications. Unlike standard care options, which typically involve antiseptic solutions and basic wound dressings, SurgX contains an antimicrobial agent designed to actively target and inhibit bacterial growth at the incision site. This gel is applied directly over the incision and re-applied during initial dressing changes, potentially enhancing its effectiveness right when it’s most needed. This targeted action could significantly reduce infection rates, a major concern in post-surgical recovery.

What evidence suggests that SurgX Antimicrobial Wound Gel might be an effective treatment for surgical site complications?

Research has shown that SurgX Antimicrobial Wound Gel targets bacteria to reduce post-surgery problems. It breaks down both free-floating bacteria and those shielded by biofilms, which help bacteria evade treatments. In this trial, participants in the treatment group will receive SurgX Antimicrobial Wound Gel alongside standard care. Some studies did not find a significant effect on reducing minor surgical infections, but the gel aims to kill bacteria on surgical wounds. By lowering bacterial counts, the gel can aid wound healing and reduce complications. Although results are mixed, the gel's approach to tackling hard-to-treat bacterial layers shows promise. ^{1 2 4 5 6}

Who Is on the Research Team?

Giles Scuderi

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for primary hip or knee replacement surgery and can consent to participate. They must be able to follow the study's procedures throughout its duration. People with allergies to any study products, mental impairments preventing proper consent, or those considered vulnerable under specific federal regulations cannot join.

Inclusion Criteria

I am scheduled for a hip or knee replacement surgery.

I am willing and able to follow the study's requirements and be available for its duration.

Provide signed and dated informed consent

Exclusion Criteria

Unable to provide signed and dated informed consent

I am willing and able to follow all study-related procedures.

Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SurgX™ Antimicrobial Wound Gel applied over incision after closure and re-applied at first dressing change on day of discharge

Immediate post-surgery

In-person during surgery and at discharge

Follow-up

Participants are monitored for surgical site complications and wound healing outcomes

12 weeks

Regular in-person assessments

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• SurgX Antimicrobial Wound Gel

Trial Overview The trial is testing SurgX Antimicrobial Wound Gel against standard wound care in patients undergoing hip or knee replacements. The goal is to see if SurgX reduces complications and improves outcomes by targeting bacteria at the surgical site.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

The treatment group will receive SurgX™ Antimicrobial Wound Gel™ applied over incision after closure and then re-applied at first dressing change on day of discharge in addition to standard of care.

Group II: Control Group Experimental Treatment 1 Intervention

The control group will receive standard of care.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Next Science

Collaborator

Trials

2

Recruited

1,600+

Next Science TM

Industry Sponsor

Trials

17

Recruited

9,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10290534/

Superficial Surgical Site Infections in Primary Total Joint ... Next Science SURGX® Wound Gel did not demonstrate a statistically significant effect on the rate of superficial SSI in total joint arthroplasty.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05919888?term=deep-2&viewType=Table&rank=4

SURGX Antimicrobial Gel Versus Povidone-iodine Skin ... SURGX wound gel is a topical antiseptic gel agent to be used on surgical incisions to prevent bacterial infection. Intervention/Treatment, Device : SURGX Wound ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8684887/

Antimicrobial effectiveness of wound matrices containing ... This study shows that a novel collagen matrix containing an antimicrobial agent can reduce the bacterial load and support healing.

4. ctv.veeva.com ctv.veeva.com/study/clinical-evaluation-of-the-next-science-surgx-antimicrobial-wound-gel-impact-on-surgical-site-compli

Clinical Evaluation of the Next Science SurgX Antimicrobial ... It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative ...

5. fda.gov fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/next-science-llc-698114-02212025

Next Science LLC - 698114 - 02/21/2025 “SURGX® is designed to reduce surgical site and post-surgical infections by destroying planktonic and biofilm-encased bacteria within the gel.

6. zimmerbiomet.com zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/surgical/surgx-sterile-antimicrobial-gel/3426.1-US-en-SURGX-Product-Brochure.pdf

SURGX™ Sterile Antimicrobial Gel Leveraging Next Science®'s patented XBIO® technology, the formulation deconstructs biofilm by chelating the metallic bonds holding the polymers together.