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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05517278
• Other study ID #: 21-1050
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2024
• Source: Northwell Health
• Contact: Meriton Ruhani
• Phone: 212-434-4724
• Email: mruhani[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty
• Total Knee Arthroplasty

Intervention

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.
• Standard of Care
The control group will receive standard of care.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Lenox Hill Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Next Science TM

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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/

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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