What side effects are associated with this type of intervention?

The most common side effects of antiseptic skin preparation solutions used in the treatment of leg fractures include skin irritation, allergic reactions, and contact dermatitis. In rare instances, severe hypersensitivity reactions may occur. Prolonged exposure or improper use can also result in skin dryness and damage.

What prior FDA approvals exist?

The FDA has approved various antiseptic skin preparation solutions aimed at reducing surgical site infections by killing bacteria and decreasing native skin flora. These solutions are commonly used in the operative management of extremity fractures, including leg fractures. While specific FDA approvals for leg fracture treatments are not detailed, the general practice involves the use of antiseptic solutions such as chlorhexidine gluconate and povidone-iodine, which are effective in minimizing the risk of infection during surgery.

What other types of research exist?

Promising novel alternatives to traditional antiseptic skin preparation solutions for leg fracture patients include: 1) Chlorhexidine-alcohol combinations, which have shown superior efficacy in reducing SSIs compared to povidone-iodine. 2) Advanced iodine-based solutions with sustained-release properties that provide prolonged antimicrobial activity. 3) Antimicrobial peptides and nanotechnology-based solutions that offer targeted bacterial eradication with minimal cytotoxicity. These alternatives are being explored for their enhanced effectiveness and safety profiles.

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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.

Select...

I have burns at the site of my fracture.

Select...

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.

Select...

I had surgery for my fracture at a hospital or clinic not involved in this study.

Select...

I cannot use certain pre-surgery solutions due to health reasons.

Select...

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of the patient's last planned fracture management surgery

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

0 / 13Eligibility criteria met

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.

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