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

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.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty; Total Hip Arthroplasty
• Intervention / Treatment: Other: SurgX Antimicrobial Wound Gel; Other: Standard of Care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center
    • New York, New York, United States, 10075
      • Lenox Hill Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Other: Control Group; The control group will receive standard of care.	Other: Standard of Care; The control group will receive standard of care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: Next Science TM
• Investigators: Principal Investigator: Giles Scuderi, Northwell Health

Publications and helpful links

General Publications

• Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
• Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
• Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
• Doyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Actual): July 15, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 21-1050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No