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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-07-15

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.

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Detailed Description

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Conditions

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Total Hip Arthroplasty Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

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 Type EXPERIMENTAL

SurgX Antimicrobial Wound Gel

Intervention Type OTHER

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.

Control Group

The control group will receive standard of care.

Group Type OTHER

Standard of Care

Intervention Type OTHER

The control group will receive standard of care.

Interventions

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SurgX Antimicrobial Wound Gel

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.

Intervention Type OTHER

Standard of Care

The control group will receive standard of care.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes