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

Study Overview
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Brief Summary
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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.

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

Conditions
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Total Hip Arthroplasty, Total Knee Arthroplasty

Intervention / Treatment
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* Other: SurgX Antimicrobial Wound Gel
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years or older Scheduled to undergo primary hip or knee arthroplasty Willing and able to comply with all study procedures and be available for the duration of the study Provide signed and dated informed consent Exclusion Criteria: Unable to provide signed and dated informed consent Unable or unwilling to comply with 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) Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Other: SurgX Antimicrobial Wound Gel<br>* In addition to standard of care, at time of surgery, SurgX applied on the incision after closure and then re-applied at the time of first bandage change on day of discharge.<br>|
| Other: Control Group<br>The control group will receive standard of care. | Other: Standard of Care<br>* The control group will receive standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site complication | Presence/absence of a surgical site complication. Surgical site complications to be defined as meeting at least one of the below criteria: Bacterial or fungal infection as confirmed by PCR swabs Hypertrophic scar formation as diagnosed by in-person assessment via the study investigator Superficial granuloma formation as diagnosed by in-person assessment via study investigator Wound dehiscence as diagnosed by in-person assessment via study investigator Presence of discharge as diagnosed by in-person assessment via study investigator Presence of wound redness as diagnosed by in-person assessment via study investigator Presence of stitch abscess as diagnosed by in-person assessment via study investigator Superficial surgical site infection as diagnosed by in-person assessment via study investigator in accordance with the NHSN SSI Checklist | within 12 weeks of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound images | Third party assessment of wound images taken with Tissue Analytics via blinded assessor to corroborate the investigator's assessment using the below criteria: Hypertrophic scar formation Superficial granulation Wound dehiscence Discharge Wound redness Stitch abscess | 12 weeks after index procedure |