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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP FREPP


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All Clinical Trials for CHLORAPREP ONE-STEP FREPP

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00290290 ↗ Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Medical College of Wisconsin Phase 3 2003-09-01 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗ Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Michael Debakey Veterans Affairs Medical Center Phase 3 2003-09-01 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗ Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed Michael E. DeBakey VA Medical Center Phase 3 2003-09-01 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
NCT00290290 ↗ Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections Completed US Department of Veterans Affairs Phase 3 2003-09-01 Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for CHLORAPREP ONE-STEP FREPP

Condition Name

123320024681012Surgical Site InfectionSurgical Skin PreparationAnesthesia, LocalInfection[disabled in preview]
Condition Name for CHLORAPREP ONE-STEP FREPP
Intervention Trials
Surgical Site Infection 12
Surgical Skin Preparation 3
Anesthesia, Local 3
Infection 2
[disabled in preview] 0
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Condition MeSH

14665002468101214Surgical Wound InfectionCommunicable DiseasesInfectionsInfection[disabled in preview]
Condition MeSH for CHLORAPREP ONE-STEP FREPP
Intervention Trials
Surgical Wound Infection 14
Communicable Diseases 6
Infections 6
Infection 5
[disabled in preview] 0
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Clinical Trial Locations for CHLORAPREP ONE-STEP FREPP

Trials by Country

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Trials by Country for CHLORAPREP ONE-STEP FREPP
Location Trials
United States 50
Canada 3
Italy 2
United Kingdom 2
El Salvador 1
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Trials by US State

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Trials by US State for CHLORAPREP ONE-STEP FREPP
Location Trials
Virginia 9
Montana 7
Pennsylvania 4
Wisconsin 3
Massachusetts 3
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Clinical Trial Progress for CHLORAPREP ONE-STEP FREPP

Clinical Trial Phase

45.7%37.1%11.4%5.7%0246810121416Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for CHLORAPREP ONE-STEP FREPP
Clinical Trial Phase Trials
Phase 4 16
Phase 3 13
Phase 2 4
[disabled in preview] 2
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Clinical Trial Status

69.2%12.8%10.3%7.7%0510152025CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for CHLORAPREP ONE-STEP FREPP
Clinical Trial Phase Trials
Completed 27
Recruiting 5
Not yet recruiting 4
[disabled in preview] 3
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Clinical Trial Sponsors for CHLORAPREP ONE-STEP FREPP

Sponsor Name

trials0123456789Zurex Pharma, Inc.3MUniversity of California, San Diego[disabled in preview]
Sponsor Name for CHLORAPREP ONE-STEP FREPP
Sponsor Trials
Zurex Pharma, Inc. 9
3M 6
University of California, San Diego 4
[disabled in preview] 4
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Sponsor Type

57.4%36.1%6.6%005101520253035OtherIndustryU.S. Fed[disabled in preview]
Sponsor Type for CHLORAPREP ONE-STEP FREPP
Sponsor Trials
Other 35
Industry 22
U.S. Fed 4
[disabled in preview] 0
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CHLORAPREP ONE-STEP FREPP Market Analysis and Financial Projection

Chloraprep One-Step Frepp: A Comprehensive Overview

Introduction

Chloraprep One-Step Frepp is a widely recognized antiseptic skin preparation product, formulated with 2% chlorhexidine gluconate and 70% isopropyl alcohol. This product has been a cornerstone in infection control, particularly in healthcare settings, for its efficacy in reducing the risk of various infections.

Clinical Efficacy and Mechanism

Chloraprep One-Step has been proven to significantly reduce the number of microorganisms on intact skin. The combination of chlorhexidine gluconate and isopropyl alcohol provides a broad-spectrum antibacterial effect, with chlorhexidine gluconate being particularly effective against a wide range of bacteria, including those responsible for nosocomial infections[2].

Persistent Antimicrobial Activity

One of the key benefits of Chloraprep One-Step is its persistent antimicrobial activity. A single 30-second application can provide antimicrobial protection for more than 48 hours, making it an invaluable tool in preventing infections such as catheter-related bloodstream infections (CRBSIs) and surgical site infections (SSIs)[2][4].

Clinical Trials and Studies

Several clinical trials and studies have underscored the effectiveness of Chloraprep One-Step.

Reduction in Infections

A study published in the New England Journal of Medicine found that the use of Chloraprep solution reduced infections by 41%. This study highlighted the product's efficacy in patient safety and infection control[5].

FDA Approval and Recommendations

Chloraprep One-Step has been approved by the FDA for use as a patient pre-operative skin preparation and pre-injection preparation. It is the only FDA-approved 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol formulation available in the United States. The Centers for Disease Control and Prevention (CDC) also recommends a 2% chlorhexidine-based antiseptic solution for skin preparation prior to catheter insertion[2].

Market Analysis

Market Presence and Suppliers

Chloraprep One-Step is marketed by Becton Dickinson Co and is included in two New Drug Applications (NDAs). The product has a strong global presence, with twelve patent family members in eleven countries. There are multiple suppliers listed for the raw ingredients, chlorhexidine gluconate and isopropyl alcohol[1].

Product Variations

The product is available in various applicator sizes, including 1 mL, 1.5 mL FREPP, 3 mL, 10.5 mL, and 26 mL, catering to different prep site requirements. The 0.67 mL Sepp applicator is designed for hands-off aseptic application to smaller areas, offering benefits such as a unique non-linting tip, longer shelf-life, and exclusive triple-wall construction[2][4].

Market Projections

Demand and Growth

The demand for antiseptic skin preparations like Chloraprep One-Step is driven by the increasing need to prevent nosocomial infections and other healthcare-associated infections. Given the product's efficacy and FDA approval, it is expected to maintain a strong market presence.

Competitive Landscape

The market for antiseptic skin preparations is competitive, but Chloraprep One-Step's unique formulation and FDA approval give it a significant edge. The product's compliance with CDC guidelines further solidifies its position in the market[2].

Economic Impact

Cost Savings

By reducing the incidence of infections such as CRBSIs and SSIs, Chloraprep One-Step can significantly reduce healthcare costs. Nosocomial infections are a major financial burden on the healthcare industry, and effective prevention measures like Chloraprep One-Step can mitigate these costs[2].

Market Size and Growth

While specific financial projections for Chloraprep One-Step are not publicly available, the broader market for infection control products is expected to grow due to increasing awareness and stringent infection control measures. The global market for such products is anticipated to see steady growth driven by the need for effective infection prevention strategies[3].

Recent Developments and Innovations

New Applicator Designs

The introduction of the 0.67 mL Sepp applicator has enhanced the product's usability and safety. This design ensures minimal excess and no mess, making it more convenient for healthcare professionals[2].

Regulatory Compliance

Chloraprep One-Step continues to meet and exceed regulatory standards. The product's compliance with CDC guidelines and FDA approval ensures that it remains a trusted choice in infection control[2].

Key Takeaways

  • Efficacy: Chloraprep One-Step is highly effective in reducing microorganisms on the skin, providing persistent antimicrobial activity.
  • FDA Approval: It is the only FDA-approved 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol formulation.
  • Market Presence: Available in various applicator sizes and widely used globally.
  • Cost Savings: Reduces healthcare costs by preventing nosocomial infections.
  • Regulatory Compliance: Meets CDC guidelines and FDA standards.

FAQs

What is the active ingredient in Chloraprep One-Step?

The active ingredients are 2% chlorhexidine gluconate and 70% isopropyl alcohol[1][2].

What are the common uses of Chloraprep One-Step?

It is used as a patient pre-operative skin preparation and pre-injection preparation to prevent infections such as CRBSIs and SSIs[2].

Is Chloraprep One-Step FDA-approved?

Yes, it is FDA-approved for its specified uses[2].

How long does the antimicrobial effect of Chloraprep One-Step last?

The antimicrobial effect can last for more than 48 hours after a single 30-second application[2].

What sizes are the Chloraprep One-Step applicators available in?

The applicators are available in 1 mL, 1.5 mL FREPP, 3 mL, 10.5 mL, and 26 mL sizes[2][4].

Sources

  1. Drug Patent Watch: CHLORAPREP ONE-STEP Drug Patent Profile.
  2. Infection Control Today: FDA Approves ChloraPrep One-Step Sepp Applicator.
  3. Fortune Business Insights: Antipsychotic Drugs Market Size, Share | Growth [2024-2032].
  4. BD United Kingdom: BD ChloraPrep™ skin preparation.
  5. MassDevice: NEJM backs ChloraPrep study in patient safety scandal.

More… ↓

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