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Showing 1–21 of 21 matching trials from the live ClinicalTrials.gov search.
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Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement

NCT06489431
Conditions
Erectile Dysfunction, Penile Prosthesis; Complications, Infection or Inflammation
Interventions
Chlorhexidine, Gentamicin, Rifampin
Drug
Lead sponsor
Rush University Medical Center
Other
Eligibility
Male only
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2027
U.S. locations
3
States / cities
Mountain View, California • Chicago, Illinois • Des Plaines, Illinois
Conditions
Abscess
Interventions
Standard of Care (SoC), Irrisept Delivery System
Device
Lead sponsor
Irrimax Corporation
Industry
Eligibility
12 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Gainesville, Florida
Conditions
Breast Cancer
Interventions
Chlorhexidine irrigation, triple antibiotic irrigation
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
18 Years to 81 Years · Female only
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Nashville, Tennessee
Conditions
Skin and Soft Tissue Infections, Abscess
Interventions
Standard of Care (SoC), Irrisept Delivery System
Device
Lead sponsor
Irrimax Corporation
Industry
Eligibility
18 Years to 80 Years
Enrollment
114 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Tampa, Florida
Recruiting Not applicable Interventional Accepts healthy volunteers

Wound Irrigation Comparative Effectiveness Study

NCT06379919
Conditions
Cutibacterium Acnes Contamination
Interventions
Irrisept Irrigation, Saline Irrigation Solution Delivery
Procedure
Lead sponsor
Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Other
Eligibility
18 Years and older
Enrollment
126 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2027
U.S. locations
1
States / cities
Orange, California
Conditions
Urinary Tract Infection, Antibiotic, Catheter Infection
Interventions
0.05% Chlorhexidine Gluconate, Normal Saline
Other
Lead sponsor
Ohio State University
Other
Eligibility
18 Years and older
Enrollment
300 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
1
States / cities
Columbus, Ohio
Conditions
Abscess
Interventions
IRRISEPT, Usual Care
Device · Procedure
Lead sponsor
University of Florida
Other
Eligibility
12 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
1
States / cities
Gainesville, Florida
Conditions
Bladder Cancer, Urinary Tract Infection
Interventions
Irrisept® Antimicrobial Wound Lavage
Device
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
New York, New York
Conditions
Surgical Site Infection
Interventions
IrriSept System, No Intervention - Standard of Care (SoC) only
Device · Other
Lead sponsor
Irrimax Corporation
Industry
Eligibility
18 Years and older
Enrollment
627 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
17
States / cities
Tucson, Arizona • Los Angeles, California • Denver, Colorado + 14 more
Conditions
Lumbar Spine Degeneration, Cervical Spine Degeneration
Interventions
saline 0.9%, (0.05% chlorhexidine gluconate (CHG) in sterile water)
Drug
Lead sponsor
University of Missouri-Columbia
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2026
U.S. locations
1
States / cities
Columbia, Missouri
Completed Phase 4 Interventional Accepts healthy volunteers

Irrisept C.Acnes Study

NCT03938467
Conditions
Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Interventions
Antiseptic Cleanser
Drug
Lead sponsor
Orthopaedic Associates of Michigan, PC
Other
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2024
U.S. locations
1
States / cities
Grand Rapids, Michigan
Conditions
Pilonidal Disease
Interventions
Irrisept (0.05% chlorhexidine gluconate), Normal Saline
Device · Other
Lead sponsor
Yosef Nasseri, MD
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
Los Angeles, California
Conditions
Cesarean Section Complications, Cesarean Section; Infection
Interventions
Irrisept, Normal Saline
Device · Drug
Lead sponsor
Loma Linda University
Other
Eligibility
18 Years and older · Female only
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Loma Linda, California
Conditions
Neurogenic Bladder, Urinary Retention
Interventions
Bladder instillation with Irrisept
Device
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
70 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
New Haven, Connecticut
Conditions
Gustilo-Anderson Type III Open Tibia Fracture
Interventions
Irrisept (Irrigation Solution), Saline
Drug
Lead sponsor
Brett D. Crist
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Columbia, Missouri
Enrolling by invitation Not applicable Interventional

Irrisept Spinal Fusion Pilot Study Protocol

NCT05011942
Conditions
Lumbar Spine Disease
Interventions
Irrisept Irrigation solution
Device
Lead sponsor
University of Kansas Medical Center
Other
Eligibility
18 Years to 85 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Kansas City, Kansas
Completed Not applicable Interventional Results available

Retrospective Independent Safety Review of Closed Irrisept Study

NCT05359666
Conditions
Adverse Events
Interventions
Irrisept, Standard of Care
Device
Lead sponsor
Irrimax Corporation
Industry
Eligibility
Not listed
Enrollment
592 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
17
States / cities
Tucson, Arizona • Los Angeles, California • Denver, Colorado + 14 more
Conditions
Post-Op Complication, Spine Surgery, Site Infection, Surgical Site Infection, Spinal Instrumentation, Index Spinal Instrumentation, Layer-by-Layer Closure, Locoregional Flap-Based Closure
Interventions
Chlorhexidine gluconate solution, Vancomycin
Device · Drug
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Providence, Rhode Island
Conditions
Diabetic Foot Ulcer
Interventions
Irrisept, Saline
Device
Lead sponsor
Northern Illinois Foot and Ankle Specialists
Other
Eligibility
18 Years and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
5
States / cities
Cary, Illinois • Crystal Lake, Illinois • Elgin, Illinois + 2 more
Enrolling by invitation Phase 4 Interventional

Irrisept in Emergency General Surgery Patients

NCT07048899
Conditions
Emergency Surgery, Surgical Site Infections
Interventions
Chlorhexidine, Normal Saline
Drug
Lead sponsor
The University of Texas Health Science Center at Tyler
Other
Eligibility
18 Years and older
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
1
States / cities
Tyler, Texas
Conditions
Surgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection
Interventions
Povidone-Iodine, SURGX Wound Gel
Drug · Device
Lead sponsor
St. Louis University
Other
Eligibility
18 Years to 90 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023
U.S. locations
1
States / cities
St Louis, Missouri