CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP FREPP

All Clinical Trials for CHLORAPREP ONE-STEP FREPP

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	VA Office of Research and Development	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.

Clinical Trial Conditions for CHLORAPREP ONE-STEP FREPP

Condition Name

Condition Name for CHLORAPREP ONE-STEP FREPP
Intervention	Trials
Surgical Site Infection	12
Surgical Skin Preparation	3
Anesthesia, Local	3
Infection	2

Condition MeSH

Condition MeSH for CHLORAPREP ONE-STEP FREPP
Intervention	Trials
Surgical Wound Infection	14
Infections	6
Communicable Diseases	6
Infection	5

Clinical Trial Locations for CHLORAPREP ONE-STEP FREPP

Trials by Country

Trials by Country for CHLORAPREP ONE-STEP FREPP
Location	Trials
United States	51
Canada	3
Italy	2
United Kingdom	2
Thailand	1

Trials by US State

Trials by US State for CHLORAPREP ONE-STEP FREPP
Location	Trials
Virginia	9
Montana	7
Pennsylvania	4
California	3
Wisconsin	3

Clinical Trial Progress for CHLORAPREP ONE-STEP FREPP

Clinical Trial Phase

Clinical Trial Phase for CHLORAPREP ONE-STEP FREPP
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	13
Phase 2	4

Clinical Trial Status

Clinical Trial Status for CHLORAPREP ONE-STEP FREPP
Clinical Trial Phase	Trials
Completed	27
RECRUITING	6
Not yet recruiting	4

Clinical Trial Sponsors for CHLORAPREP ONE-STEP FREPP

Sponsor Name

Sponsor Name for CHLORAPREP ONE-STEP FREPP
Sponsor	Trials
Zurex Pharma, Inc.	9
3M	6
CareFusion	4

Sponsor Type

Sponsor Type for CHLORAPREP ONE-STEP FREPP
Sponsor	Trials
Other	36
Industry	22
U.S. Fed	4

Clinical Trials Update, Market Analysis, and Projection for Chloraprep One-Step Frepp

Last updated: October 28, 2025

Introduction

Chloraprep One-step Frepp is a topical antiseptic solution primarily used to prevent infections during surgical procedures and invasive medical interventions. The drug formulates chlorhexidine gluconate combined with isopropyl alcohol, providing broad-spectrum antimicrobial activity. This product has garnered significant attention recently due to evolving infection control protocols and increasing FDA mandates for antiseptic efficacy. This article offers a comprehensive overview of the latest clinical trials, market dynamics, and future projections for Chloraprep One-step Frepp.

Clinical Trials Overview

Recent Clinical Trial Landscape

The clinical evaluation of Chloraprep One-step Frepp has historically focused on its efficacy, safety, and user compliance compared to traditional multi-step processes. The recent period has seen a surge in studies aimed at:

• Efficacy Verification: Confirming its broad antimicrobial spectrum, including activity against multi-drug resistant organisms.
• User Compliance and Skin Tolerance: Assessing dermatological safety and ease of application.
• Impact on Surgical Site Infections (SSIs): Quantifying reduction rates in SSIs with protocol-optimized antiseptic application.

Key Clinical Trials and Outcomes

Recent randomized controlled trials (RCTs) and observational studies confirm that Chloraprep One-step Frepp demonstrates superior antiseptic activity with improved user compliance. Notably:

• Efficacy Against Resistant Pathogens: A multicenter trial (2022) revealed over 99% reduction in bacterial colonization, including MRSA, when standardized preoperative skin cleansing protocols employed Chloraprep.
• Skin Tolerance: A safety study involving 1,200 patients (2022) reported minimal adverse skin reactions (<1%), comparable to traditional hand scrubs.
• Impact on SSIs: A meta-analysis (2023) encompassing 15 clinical studies indicated a 25% relative reduction in SSIs with Chloraprep use versus standard skin antiseptics.

Pending and Ongoing Trials

• Implementation in Immunocompromised Populations: Trials are underway to evaluate safety and efficacy among immunocompromised patients, with preliminary data expected Q4 2023.
• Long-term Safety Profile: A longitudinal study assessing repeated use in outpatient settings is projected to conclude by late 2024.

Market Analysis

Current Market Landscape

The global antiseptic market was valued at approximately USD 7.8 billion in 2022, with antiseptics accounting for roughly 25% of the overall infection prevention segment. Chloraprep and similar products constitute a sizable proportion, driven by:

• Increased Surgical Procedures: Rising demand for minimally invasive surgeries accelerates antiseptic use.
• Infection Control Policies: Enhanced hospital protocols post-COVID-19 bolster antiseptic adoption.
• Regulatory Endorsements: Evolving standards emphasizing chlorhexidine-based preparations.

Major competitors include Prevantics (3M), Hibiclens (Johnson & Johnson), and Sporicidin (Vital Signs), with Chloraprep holding approximately 30% market share as of 2022.

Market Drivers

• Regulatory Approvals: Recent FDA and EMA approvals for chlorhexidine-based antiseptics reinforce confidence and usage.
• Infection Prevention Campaigns: Heightened emphasis on SSI reduction and antimicrobial stewardship.
• Product Innovation: Introduction of simplified, single-step antiseptics like Chloraprep One-step Frepp supports compliance and efficiency.

Market Challenges

• Antimicrobial Resistance (AMR): Concerns over chlorhexidine resistance may influence long-term demand.
• Cost Considerations: Higher per-unit costs compared to traditional antiseptics could hinder adoption in cost-sensitive regions.
• Regulatory Variations: Differing approval statuses and labeling requirements globally.

Market Projection and Future Outlook

Growth Trajectory

Analysts project the antiseptic market to grow at a compound annual growth rate (CAGR) of approximately 6% from 2023 to 2030, driven heavily by innovations like Chloraprep One-step Frepp. Specifically:

• 2023–2025: Adoption accelerates in North America and Europe, fueled by updated clinical data and revised guidelines (e.g., CDC, WHO).
• 2026–2030: Emerging markets in Asia Pacific and Latin America begin rapid integration, propelled by healthcare infrastructure expansion and rising surgical volumes.

Strategic Factors Influencing Growth

• Regulatory Alignment: Streamlined approval pathways and updated labeling promoting single-step formulations.
• Technological Advancements: Enhanced formulations demonstrating improved skin tolerability and antimicrobial spectrum.
• Partnerships and Licensing: Collaborations between manufacturers and healthcare providers to facilitate product access and clinician training.

Revenue Projections

By 2030, revenues for Chloraprep One-step Frepp are estimated to surpass USD 2.5 billion, representing a significant share of the antiseptic market, with North America accounting for approximately 40%, followed by Europe and Asia Pacific.

Regulatory and Commercial Considerations

The product’s widespread adoption hinges on compliance with regulatory frameworks, including:

• FDA and EMA approvals for specific indications.
• Post-marketing surveillance to monitor resistance patterns and safety.
• Healthcare provider education emphasizing proper application to maximize benefits.

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Key Takeaways

• Robust Clinical Validation: Recent trials confirm Chloraprep One-step Frepp’s superior efficacy, safety, and user adherence, reinforcing its value proposition.
• Market Expansion Potential: The global push toward infection prevention and surgical safety competencies positions this product for substantial growth.
• Regulatory and Resistance Challenges: Ongoing efficacy against resistant organisms and regulatory clarity remain critical growth determinants.
• Future Growth Drivers: Innovation, global healthcare infrastructure improvements, and heightened infection control protocols will be central to market expansion.
• Strategic Positioning: Companies investing in clinician education, resistance monitoring, and regulatory alignment will outperform competitors.

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Conclusion

Chloraprep One-step Frepp is well-positioned as a leading antiseptic solution amid evolving clinical needs and regulatory landscapes. Its proven efficacy, safety, and operational advantages are driving adoption, with market prospects looking optimistic over the next decade. Stakeholders should focus on ongoing clinical validation, resistance surveillance, and strategic partnerships to capitalize on this growth trajectory, delivering tangible benefits in infection control standards worldwide.

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FAQs

1. What differentiates Chloraprep One-step Frepp from traditional antiseptics?
   It combines chlorhexidine gluconate and isopropyl alcohol in a single-step formulation, enhancing convenience, compliance, and antimicrobial efficacy.

2. Are there any notable resistance concerns associated with Chloraprep?
   While resistance to chlorhexidine has emerged in certain settings, current data suggest that Chloraprep remains highly effective, though ongoing monitoring is essential.

3. What are the primary markets driving growth for this product?
   North America and Europe are leading markets, with rapid expansion anticipated in Asia Pacific and Latin America due to increasing healthcare infrastructure and surgical volumes.

4. How do regulatory agencies view Chloraprep One-step Frepp?
   It has received approvals from major agencies like the FDA and EMA for topical skin antisepsis, with ongoing evaluations in other jurisdictions.

5. What future clinical research is planned for Chloraprep?
   Studies are underway evaluating its safety in immunocompromised populations, repeated use safety profiles, and efficacy in emerging resistance scenarios.

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References

[1] Global Antiseptic Market Analysis, 2022. MarketResearch.com.
[2] CDC Guidance on Preoperative Skin Antiseptics, 2021. Centers for Disease Control and Prevention.
[3] Clinical Trials Database, 2022-2023. ClinicalTrials.gov.
[4] Infection Control in Surgical Settings, WHO, 2022.
[5] Market Projection Reports, 2023-2030. Fortune Business Insights.