Total Hip Arthroplasty, Total Knee Arthroplasty
Conditions
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.
Interventions
OTHERSurgX 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.
OTHERStandard of Care
The control group will receive standard of care.
Sponsors
Next Science TM
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed