Antimicrobial Wound Gel for Surgical Site Complications

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

Trial Summary

What is the purpose of this trial?

This is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.

Research Team

Giles Scuderi

Principal Investigator

Northwell Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+