SurgX Antimicrobial Wound Gel for ST13 protein, human
Phase-Based Progress Estimates
Effectiveness
Safety
Long Island Jewish Medical Center, New Hyde Park, NY
ST13 protein, human+1 More
SurgX Antimicrobial Wound Gel - OtherEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study 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.
Eligible Conditions
- ST13 protein, human
- Total Knee Arthroplasty (TKA)
Treatment Effectiveness
Effectiveness Progress
Other trials for ST13 protein, human
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 12 weeks after index procedure
Week 12
Wound images
Week 12
Surgical site complication
Trial Safety
Safety Progress
Other trials for ST13 protein, human
Trial Design
1 Treatment Group
Treatment Group
1 of 1
Experimental Treatment
700 Total Participants · 1 Treatment Group
Primary Treatment: SurgX Antimicrobial Wound Gel · No Placebo Group · N/A
Treatment Group
Other
Experimental Group · 1 Intervention: SurgX Antimicrobial Wound Gel · Intervention Types: OtherTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after index procedure
Closest Location: Long Island Jewish Medical Center · New Hyde Park, NY
2007First Recorded Clinical Trial
0 TrialsResearching ST13 protein, human
149 CompletedClinical Trials
Who is running the clinical trial?
Northwell HealthLead Sponsor
409 Previous Clinical Trials
289,510 Total Patients Enrolled
Next ScienceUNKNOWN
1 Previous Clinical Trials
936 Total Patients Enrolled
Giles ScuderiPrincipal InvestigatorNorthwell Health
1 Previous Clinical Trials
936 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are a male or female 18 years or older.
You are scheduled to undergo primary hip or knee arthroplasty.
You are willing and able to comply with all study procedures and be available for the duration of the study.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- 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/
- Moonesinghe, Suneetha Ramani, Michael G. Mythen, Priya Das, Kathryn M. Rowan, and Michael P. W. Grocott. 2013. “Risk Stratification Tools for Predicting Morbidity and Mortality in Adult Patients Undergoing Major Surgery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0b013e3182a4e94d.
- Gronbeck, Christian, Mark P. Cote, Jay R. Lieberman, and Mohamad J. Halawi. 2019. “Risk Stratification in Primary Total Joint Arthroplasty: The Current State of Knowledge”. Arthroplasty Today. Elsevier BV. doi:10.1016/j.artd.2018.10.002.
- Bilimoria, Karl Y., Yaoming Liu, Jennifer L. Paruch, Lynn Zhou, Thomas E. Kmiecik, Clifford Y. Ko, and Mark E. Cohen. 2013. “Development and Evaluation of the Universal ACS NSQIP Surgical Risk Calculator: A Decision Aid and Informed Consent Tool for Patients and Surgeons”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2013.07.385.
- Giles Scuderi 2022. "Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05517278.
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