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

NCT05517278 | Withdrawn

• 1 other identifier: 21-1050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Total Hip Arthroplasty; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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: 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

  within 12 weeks of the index procedure

Secondary Outcomes (1)

• Wound images

  12 weeks after index procedure

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

OTHER

The control group will receive standard of care.

Other: Standard of Care

Interventions

SurgX Antimicrobial Wound Gel 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.

Treatment Group

Standard of Care OTHER

The control group will receive standard of care.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Next Science TM: collaborator

Study Sites (3)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Related Publications (4)

• 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.

  PMID: 31020036 BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 24195875 BACKGROUND

• 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.

  PMID: 24055383 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Giles Scuderi

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery, Joint Reconstruction

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)