Phase 4
Completed N=60
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Surgery · Surgical Site Infection · Cutibacterium Acnes · Prosthetic joint infection
Source: ClinicalTrials.gov NCT05919888 ↗
Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Dec 2024
Primary outcomePrimary: Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep — 11; 9; 6 Participants — p=0.275
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
| SECONDARY Presence of Bacteria Within Shoulder Culture Using SURGX Wound Gel Prep vs. Povidone-iodine Prep |
11; 9; 6 | 0.286 |
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.
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. Informational only — not medical advice.