Phase 4 N=60 Randomized Single-blind Prevention

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

Surgery · Surgical Site Infection · Cutibacterium Acnes · Prosthetic-joint Infection

Bottom Line

View on ClinicalTrials.gov: NCT05919888 ↗

Enrolled (actual)

Serious AEs

11.7%

Results posted

Dec 2024

Primary outcome: Primary: Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep — 11; 9; 6 Participants — p=0.275

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Povidone-Iodine (Drug); SURGX Wound Gel (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: St. Louis University
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep	29; 24; 13	0.0056 sig
PRIMARY Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep	29; 24; 13	0.0056 sig
SECONDARY Presence of Bacteria Within Shoulder Culture Using SURGX Wound Gel Prep vs. Povidone-iodine Prep	11; 9; 6	0.286

Summary

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Eligibility Criteria

Inclusion Criteria

Patient is planned to undergo elective primary anatomic or reverse shoulder arthroplasty.

Exclusion Criteria

Patient is undergoing revision shoulder replacement surgery.
Patient has a known allergy to iodine, benzalkonium chloride, or polythylene glycol.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05919888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.