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Alcohol Skin Solutions for Broken Bones (PREPARE Trial)

Phase 4
Waitlist Available
Led By Gerard Slobogean, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion)
Open fracture of the appendicular skeleton
Must not have
Fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist)
Burns at the fracture site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the patient's last planned fracture management surgery
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial focuses on using special cleaning solutions to kill bacteria on the skin before surgery. It targets patients with broken bones in their arms, legs, or pelvis who need surgery. The goal is to reduce the risk of infections after surgery by cleaning the skin thoroughly.

Who is the study for?
Adults over 18 with open fractures needing surgery within 72 hours of injury can join. They must be treated by a participating surgeon, consent to the study, and not be in conflicting trials or have communication barriers.
What is being tested?
The trial is testing two skin cleaning solutions, DuraPrep and ChloraPrep, used before surgery on broken bones to prevent infections. It aims to find out which one is better at reducing bacteria and infection risks.
What are the potential side effects?
Potential side effects from DuraPrep and ChloraPrep may include skin irritation or allergic reactions at the application site. However, these are generally mild as they're topical antiseptics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for a fracture.
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I have a broken bone that is exposed through my skin.
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I have had or will have surgery to fix a bone fracture using implants.
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My fracture surgery will be done by a surgeon in the trial.
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I have a closed fracture in my leg or pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My fracture was treated by a specialist outside of the orthopedic team.
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I have burns at the site of my fracture.
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I have a broken bone in my hand below the wrist.
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I had surgery or fracture management at a hospital not part of this study.
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I had surgery for my fracture at a hospital or clinic not involved in this study.
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I cannot use certain pre-surgery solutions due to health reasons.
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I have an infection at or near where my bone was broken and first treated.
Select...
My open fracture was treated by a specialist outside of the orthopedic team.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the patient's last planned fracture management surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of the patient's last planned fracture management surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With a Deep Incisional Infection
Number of Participants With a Superficial Incisional Surgical Site Infection (SSI)
Secondary study objectives
Number of Participants With an Unplanned Fracture-Related Reoperation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Group I: First pre-op antiseptic skin solutionExperimental Treatment2 Interventions
The PREPARE trial will compare the most common alcohol-based pre-operative antiseptic skin solutions used during extremity fracture surgery. Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all eligible fracture surgeries for a two-month period.
Group II: Crossover - Second pre-op antiseptic skin solutionExperimental Treatment2 Interventions
Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all eligible fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DuraPrep
2010
Completed Phase 4
~8720
Isopropyl alcohol
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Antiseptic skin preparation solutions are commonly used in the surgical treatment of leg fractures to kill bacteria and decrease the quantity of native skin flora, thereby reducing the risk of surgical site infections (SSI). This is crucial for leg fracture patients as infections can complicate recovery, prolong hospital stays, and increase the risk of further complications. By reducing the bacterial load on the skin, these solutions help create a sterile environment essential for successful surgical outcomes.
Extremity trauma, dressings, and wound infection: should every acute limb wound have a silver lining?Diabetic foot osteomyelitis.Wound infections after minor limb lacerations: risk factors and the role of antimicrobial agents.

Find a Location

Who is running the clinical trial?

McMaster UniversityOTHER
917 Previous Clinical Trials
2,607,869 Total Patients Enrolled
1 Trials studying Open Appendicular Fracture
1,638 Patients Enrolled for Open Appendicular Fracture
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
370,885 Total Patients Enrolled
1 Trials studying Open Appendicular Fracture
1,638 Patients Enrolled for Open Appendicular Fracture
Patient-Centered Outcomes Research InstituteOTHER
576 Previous Clinical Trials
27,071,202 Total Patients Enrolled

Media Library

DuraPrep Clinical Trial Eligibility Overview. Trial Name: NCT03523962 — Phase 4
Open Appendicular Fracture Research Study Groups: Crossover - Second pre-op antiseptic skin solution, First pre-op antiseptic skin solution
Open Appendicular Fracture Clinical Trial 2023: DuraPrep Highlights & Side Effects. Trial Name: NCT03523962 — Phase 4
DuraPrep 2023 Treatment Timeline for Medical Study. Trial Name: NCT03523962 — Phase 4
~1170 spots leftby Dec 2025