Clinical trial NCT05517278: Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications
Official title: Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Hip Arthroplasty
Total Knee Arthroplasty
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Next Science TM
First posted: 2022-08-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Surgical site complication
timeFrame: within 12 weeks of the index procedure
Secondary outcomes:
measure: Wound images
timeFrame: 12 weeks after index procedure
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Giles Scuderi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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/
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.
citation: 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.