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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: Completed Phase 4 study of Surgical Site Infection and Unplanned Fracture-Related Reoperation, sponsored by University of Maryland, Baltimore.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following: 1. purulent drainage from the superficial incision. 2. organisms identified from an aseptically obtained specimen from the superficial in

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

FieldValue
Enrollment Target 1,638 participants
Start Date 2018-04-08
Est. Completion 2022-06-27
Phase Phase 4
University of Maryland, Baltimore

560 total trials

What the finished NCT03385304 record still lists

NCT03385304 is an interventional study that assigns participants to a tested intervention. Its 1,638 participants enrollment target places it among the larger protocols in the corpus, above the 503-participant average among 25 other Surgical Site Infection trials with a reported enrollment target (226% higher).

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 lists 15 locations in 11 states (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.

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.

Where NCT03385304's enrollment target sits among peer trials

1,638 3rd of 25 higher than 23 of 25 other Surgical Site Infection trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Surgical Site Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03385304, the US trial registry maintained by the National Library of Medicine. NCT03385304 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.