Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications

Not Applicable

Withdrawn

• Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty
• Interventions: Other: SurgX Antimicrobial Wound Gel; Other: Standard of Care

• Registration Number: NCT05517278
• Lead Sponsor: Northwell Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2024-01
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Male or female 18 years or older
2. Scheduled to undergo primary hip or knee arthroplasty
3. Willing and able to comply with all study procedures and be available for the duration of the study
4. Provide signed and dated informed consent

Exclusion Criteria

1. Unable to provide signed and dated informed consent
2. Unable or unwilling to comply with all study-related procedures
3. 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)
4. Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections
5. Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	SurgX Antimicrobial Wound Gel	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.
Control Group	Standard of Care	The control group will receive standard of care.

Primary Outcome Measures

Name	Time	Method
Surgical site complication	within 12 weeks of the index procedure	Presence/absence of a surgical site complication. Surgical site complications to be defined as meeting at least one of the below criteria: 1. Bacterial or fungal infection as confirmed by PCR swabs; 2. Hypertrophic scar formation as diagnosed by in-person assessment via the study investigator; 3. Superficial granuloma formation as diagnosed by in-person assessment via study investigator; 4. Wound dehiscence as diagnosed by in-person assessment via study investigator; 5. Presence of discharge as diagnosed by in-person assessment via study investigator; 6. Presence of wound redness as diagnosed by in-person assessment via study investigator; 7. Presence of stitch abscess as diagnosed by in-person assessment via study investigator; 8. Superficial surgical site infection as diagnosed by in-person assessment via study investigator in accordance with the NHSN SSI Checklist

Secondary Outcome Measures

Name	Time	Method
Wound images	12 weeks after index procedure	Third party assessment of wound images taken with Tissue Analytics via blinded assessor to corroborate the investigator's assessment using the below criteria: 1. Hypertrophic scar formation; 2. Superficial granulation; 3. Wound dehiscence; 4. Discharge; 5. Wound redness; 6. Stitch abscess

Trial Locations

Locations (3)

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States