CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Povidone-Iodine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05919888
NCT05919888Phase 4Completed
CompareCT.gov

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty

St. Louis University·interventional·Posted Jun 26, 2023·Updated Dec 10, 2024

In Brief

A Phase 4 clinical trial evaluating Povidone-Iodine and SURGX Wound Gel for Surgery and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection
CountriesUnited States
CollaboratorsNext Science LLC

Timeline

Phase 4CompletedFinished
202420252026
First PostedJun 26, 2023
Enrollment StartJun 26, 2023
Primary CompletionNov 14, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.0 years ago

Interventions

Povidone-Iodinedrug

Applied to skin incision.

SURGX Wound Geldevice

Applied to skin incision.