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Antimicrobial Agent
Antimicrobial Wound Gel for Surgical Site Complications
N/A
Waitlist Available
Led By Giles Scuderi
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after index procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether a new wound treatment can reduce surgical site complications and improve post-operative treatment outcomes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed, potential side effects may include allergic reactions to ingredients in SurgX gel or skin irritation at the application site. Standard care side effects depend on the typical treatments used post-surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 12 weeks of the index procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 weeks of the index procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Surgical site complication
Secondary study objectives
Wound images
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 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 GroupExperimental Treatment1 Intervention
The control group will receive standard of care.
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Who is running the clinical trial?
Next ScienceUNKNOWN
1 Previous Clinical Trials
936 Total Patients Enrolled
Next Science TMIndustry Sponsor
15 Previous Clinical Trials
8,824 Total Patients Enrolled
Northwell HealthLead Sponsor
474 Previous Clinical Trials
468,460 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow all study-related procedures.I am scheduled for a hip or knee replacement surgery.I am 18 years old or older.I am willing and able to follow the study's requirements and be available for its duration.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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