CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Antiseptic Cleanserdrug
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/NCT03938467
NCT03938467Phase 4Completed
CompareCT.gov

Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty

Orthopaedic Associates of Michigan, PC·interventional·Posted May 6, 2019·Updated Jun 21, 2024

In Brief

A Phase 4 clinical trial evaluating Antiseptic Cleanser for Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty. Completed, enrolled 58 participants across 1 site.

Detailed Summary

A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
CountriesUnited States
CollaboratorsMercy Health

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMay 6, 2019
Enrollment StartMar 1, 2021
Primary CompletionJul 1, 2023
Study CompletionJan 1, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.2 years ago

Interventions

Antiseptic Cleanserdrug

Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.