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

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Northwell Health

Status

Not yet enrolling

Conditions

Total Hip Arthroplasty
Total Knee Arthroplasty

Treatments

Other: SurgX Antimicrobial Wound Gel
Other: Standard of Care

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05517278
21-1050

Details and patient eligibility

About

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.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

700 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Meriton Ruhani; Evangelia Zgonis

Data sourced from clinicaltrials.gov

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