Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03385304 · ClinicalTrials.gov registry record · Phase 4
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures
A Phase 4 study of Surgical Site Infection and Unplanned Fracture-Related Reoperation, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,638
- Enrollment target
- 15
- Study locations
NCT03385304 is a Phase 4 study of Surgical Site Infection and Unplanned Fracture-Related Reoperation that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 1,638 participants, above the 503-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (226% higher). The trial reports 15 study locations across 11 states.
The verdict
NCT03385304, a Phase 4 study of Surgical Site Infection and Unplanned Fracture-Related Reoperation, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,638 participants
- Enrollment target
- 15
- Study locations
Study Summary
The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.
Conditions Studied
Interventions
- DRUG 10% povidone-iodine (1% free iodine) in purified water
- DRUG 4% chlorhexidine gluconate (CHG) in purified water
Study Locations (15)
Arizona
- The CORE Institute / Banner University Medical Center - Phoenix
- Banner - University Medical Center Tucson - Tucson
Texas
- San Antonio Military Medical Center - Fort Sam Houston
- McGovern Medical School at University of Texas Health Science Center Houston - Houston
Ontario
- Hamilton Health Sciences - Hamilton
- McMaster University, Center for Evidence-Based Orthopaedics - Hamilton
Other
- Hospital Parc Tauli de Sabadell - Barcelona
- Vall d'Hebron University Hospital - Barcelona
California
- University of California San Francisco - San Francisco
Florida
- University of Florida - Gainesville
Indiana
- Indiana University Health Methodist Hospital - Indianapolis
Maryland
- University of Maryland, R Adams Cowley Shock Trauma Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,638 participants |
| Start Date | 2018-04-08 |
| Est. Completion | 2022-06-27 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03385304
The ClinicalTrials.gov registry entry for NCT03385304 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,638 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 503-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (226% higher). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions - of which 10% povidone-iodine (1% free iodine) in purified water is the first listed.
NCT03385304 reports 15 study locations spanning 11 distinct geographic areas - top geographies include Arizona, Texas, Ontario.
Frequently Asked Questions
What is clinical trial NCT03385304 about?
NCT03385304 is a clinical study titled "Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures". The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill...
What is the current status of trial NCT03385304?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,638 participants. The study started on 2018-04-08. Estimated completion is 2022-06-27.
What conditions does trial NCT03385304 study?
This clinical trial studies the following conditions: Surgical Site Infection, Unplanned Fracture-Related Reoperation, Open Appendicular Fracture.
What interventions are being tested in trial NCT03385304?
The interventions under investigation include: 10% povidone-iodine (1% free iodine) in purified water (DRUG), 4% chlorhexidine gluconate (CHG) in purified water (DRUG).
Who is sponsoring clinical trial NCT03385304?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03385304 being conducted?
This trial has 15 study locations across Arizona, California, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Site Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Decolonization to Reduce After-Surgery Events of Surgical Site Infection
RECRUITING · Phase 4
-
Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
RECRUITING · Phase 4
-
Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery
RECRUITING · Phase 4
-
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
ACTIVE NOT RECRUITING · Phase 4
-
Topical Antibiotic Prophylaxis for Eyelids
COMPLETED · Phase 4
-
Multicenter Infection Surveillance Study Following Open Heart Surgery
COMPLETED · Phase 4
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.