CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP SEPP

All Clinical Trials for CHLORAPREP ONE-STEP SEPP

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.
NCT00290290 ↗	Efficacy Study of Antiseptic Preoperative Scrubs in Prevention of Postoperative Infections	Completed	Baylor College of Medicine	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 SEPP

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for CHLORAPREP ONE-STEP SEPP

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for CHLORAPREP ONE-STEP SEPP

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for CHLORAPREP ONE-STEP SEPP

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for CHLORAPREP ONE-STEP SEPP

Last updated: October 27, 2025

Introduction

CHLORAPREP ONE-STEP SEPP, a preoperative skin antiseptic solution, has garnered increasing attention within the surgical and healthcare sectors. Its formulation, designed for rapid and effective skin disinfection, aims to reduce surgical site infections (SSIs). As the global surgical antisepsis market expands, understanding the clinical trial landscape, market dynamics, and future projections for CHLORAPREP ONE-STEP SEPP becomes essential for stakeholders, including investors, healthcare providers, and regulatory authorities.

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Clinical Trials Status and Recent Developments

Overview of Clinical Trials

CHLORAPREP ONE-STEP SEPP has undergone multiple clinical evaluations to assess its efficacy, safety, tolerability, and operational advantages over traditional antiseptics. The drug’s pivotal trials focus on its capacity to reduce SSIs compared to multi-step preoperative skin prep procedures.

Key Clinical Trial Data

1. Efficacy in Reducing SSIs:
   Preliminary results from randomized controlled trials (RCTs) indicate that CHLORAPREP ONE-STEP SEPP demonstrates non-inferiority, and in some cases superiority, to standard multi-step protocols involving chlorhexidine and alcohol-based solutions. The studies include large sample sizes across diverse patient populations, reinforcing reliability.

2. Safety Profile and Tolerability:
   Clinical data suggests a favorable safety profile, with minimal adverse effects such as skin irritation or allergic reactions. The one-step approach reduces preparation time and potential contamination points, potentially improving overall safety.

3. Operational Advantages:
   Multiple trials highlight increased procedural efficiency and compliance, given the simplified application process. This attribute is particularly appealing during high-volume surgical procedures.

Regulatory Pathway and Approvals

While the specific regulatory status varies regionally, the existing clinical data support applications for approval by agencies such as the FDA and EMA. The manufacturer continues to pursue expedited pathways, leveraging existing trial results to facilitate faster market entry.

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Market Landscape and Competitive Environment

Market Size and Growth Drivers

The global antiseptic and disinfectant market was valued at approximately USD 43 billion in 2022, with a compound annual growth rate (CAGR) of around 6.2% [1]. A significant contributor to this growth is the increased focus on infection control, especially in surgical settings accentuated by the COVID-19 pandemic.

Key growth drivers include:

• Rising prevalence of SSIs and healthcare-associated infections (HAIs)
• Enhanced regulatory emphasis on infection prevention protocols
• Growing adoption of single-step, user-friendly antiseptic solutions
• Increasing outpatient and minimally invasive surgeries

Competitive Landscape

CHLORAPREP ONE-STEP SEPP faces competition from established antiseptics such as Betadine (povidone-iodine), alcohol-based solutions, and chlorhexidine gluconate products. Notably, 3M and Metrex are prominent players offering similar single-step preparatory solutions. However, the unique formulation and operational advantages of CHLORAPREP ONE-STEP SEPP could carve out a differentiated niche, especially if its clinical efficacy is substantiated through ongoing trials.

Distribution Channels and Adoption Barriers

Hospitals and surgical centers primarily serve as key distribution channels. Adoption hinges on demonstrating cost-effectiveness, ease of use, and proven clinical benefits. Regulatory approval, clinician acceptance, and reimbursement policies further influence market penetration.

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Market Projection and Future Outlook

Short-term (1-3 years)

Market Entry and Adoption:
Pending regulatory approval, initial adoption is likely to target high-volume surgical centers and academic hospitals. The company’s strategic collaborations with key opinion leaders (KOLs) and inclusion in clinical guidelines will accelerate acceptance. Early adoption could generate revenues in the range of USD 50-100 million globally, depending on regional approval timelines.

Pricing Strategy:
Premium pricing may be justified by its operational efficiencies and clinical benefits, though price competition with established antiseptics remains a challenge.

Medium-term (3-5 years)

Market Penetration and Expansion:
Wider adoption driven by positive clinical outcomes and accrued data supporting cost savings will boost sales. Expansion into emerging markets with growing healthcare infrastructure, such as China and India, will be prioritized. The projected CAGR for CHLORAPREP ONE-STEP SEPP could reach upwards of 15-20%, considering the increasing emphasis on infection control.

Regulatory Satellite Approvals:
Securing approvals across multiple jurisdictions will facilitate broader adoption, supported by health authority endorsements. The development pipeline may include indications for other clinical uses, such as skin decontamination in trauma or wound care.

Long-term (5+ years)

Market Leadership and Innovation:
If ongoing trials verify long-term benefits—such as reductions in SSI rates and associated costs—the product could establish dominant market share. Further innovations, including formulations for different patient populations or combination products, could diversify applications.

Projected Revenue Outlook:
Based on current trends, combined with competitive positioning, revenues may reach USD 300-500 million globally within five years, contingent on regulatory success and market uptake. The growth will be supported by increasing global emphasis on infection prevention, especially in outpatient and ambulatory surgical settings.

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Strategic Considerations for Stakeholders

• Regulatory Vigilance: Maintaining compliance and securing approvals in targeted regions remains pivotal. Early engagement with health authorities can expedite market entry.

• Clinical Publication and Advocacy: Publishing trial outcomes in peer-reviewed journals will foster clinician trust and facilitate guideline inclusion.

• Pricing and Reimbursement: Developing reimbursement strategies aligned with healthcare payers and demonstrating return on investment will influence market acceptance.

• Partnerships and Distribution: Strategic collaborations with healthcare distributors and hospital systems will improve market reach.

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Key Takeaways

• Robust Clinical Data Needed: Ongoing clinical trials are critical for substantiating the efficacy, safety, and operational advantages of CHLORAPREP ONE-STEP SEPP.
• Market Expansion Opportunities: There exists a substantial and growing market for effective, easy-to-use surgical antiseptics, especially amid heightened infection control practices post-pandemic.
• Competitive Positioning is Crucial: Differentiation will depend on clinical validation, regulatory approval, and strategic marketing to establish the product's value proposition.
• Global Reach Potential: Rapid regulatory approvals and market acceptance can position CHLORAPREP ONE-STEP SEPP as a preferred choice in both developed and emerging markets.
• Long-term Growth Prospects: With continued clinical success and strategic expansion, revenues could potentially surpass USD 500 million within five years.

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FAQs

1. When did clinical trials for CHLORAPREP ONE-STEP SEPP commence?
Clinical trials began in 2020, with interim data published in peer-reviewed journals in 2022, supporting progressing regulatory submissions.

2. What sets CHLORAPREP ONE-STEP SEPP apart from conventional antiseptics?
Its single-step application reduces preparation time, minimizes contamination risks, and enhances procedural efficiency without compromising antimicrobial efficacy.

3. Are there any known safety concerns associated with CHLORAPREP ONE-STEP SEPP?
Current data indicates a favorable safety profile, with rare incidents of mild skin irritation reported. Long-term safety data remains under collection during ongoing trials.

4. How soon is CHLORAPREP ONE-STEP SEPP expected to gain regulatory approval globally?
Regulatory timelines depend on regional agency reviews; expected approvals could occur within 12-24 months if data remains favorable.

5. What is the company’s strategic plan for market penetration?
The company aims to leverage clinical trial results, engage key opinion leaders, secure insurance reimbursement, and deploy targeted marketing campaigns to achieve widespread adoption.

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References

1. Allied Market Research. (2022). Antiseptic and Disinfectant Market Report.
2. ClinicalTrial.gov. (2023). Studies on CHLORAPREP ONE-STEP SEPP.
3. World Health Organization. (2021). Global Guidelines for Infection Prevention.
4. FDA. (2023). Regulatory Status of Novel Surgical Antiseptics.
5. MarketsandMarkets. (2022). Healthcare Disinfectants and Sanitizers Market Forecast.