CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP

All Clinical Trials for CHLORAPREP ONE-STEP

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for CHLORAPREP ONE-STEP

Trials by Country

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

Clinical Trial Progress for CHLORAPREP ONE-STEP

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for CHLORAPREP ONE-STEP

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 28, 2025

Introduction

Chloraprep One-step, a well-established antiseptic skin preparation solution, primarily combines alcohol with chlorhexidine gluconate, widely used for preoperative skin disinfection. Its efficacy in reducing surgical site infections (SSIs) has positioned it as a standard in surgical protocols globally. This analysis explores recent clinical trial data, current market dynamics, competitive landscape, and future growth projections to assist stakeholders in strategic decision-making.

Clinical Trials Update

Recent Clinical Evidence Supporting Chloraprep One-step

Over the past two years, multiple clinical investigations have reinforced Chloraprep's efficacy in preoperative skin antisepsis. Notably, a randomized controlled trial (RCT) published in The Journal of Surgical Research (2022) evaluated the use of Chloraprep One-step versus povidone-iodine in surgical patients. Results demonstrated that Chloraprep reduced SSIs by 30%, with fewer adverse skin reactions and improved patient comfort [[1]].

Similarly, a large-scale study in Europe (2023) assessed the residual antimicrobial activity of Chloraprep One-step across different skin types and surgical durations. Findings confirmed sustained antimicrobial efficacy up to 6 hours post-application, essential for lengthy procedures [[2]]. These trials underscore Chloraprep's continued clinical relevance and improved formulations.

Regulatory and Approval Updates

In 2021, the FDA reaffirmed Chloraprep’s compliance with safety and efficacy standards, incorporating data from multiple clinical studies. No significant updates or new indications have emerged since, yet ongoing observational studies aim to monitor long-term safety, especially regarding chlorhexidine resistance and skin sensitivities [[3]].

Emerging Research and Innovations

Researchers are investigating Chloraprep's potential beyond surgical antisepsis. Preliminary trials suggest its utility in dermatological infections and as an adjunct in wound care with enhanced formulations, including alcohol-free variants to mitigate skin irritation [[4]]. However, these are in early investigational phases.

Market Overview and Dynamics

Global Market Size and Growth

The antiseptic and disinfectant market, valued at approximately USD 14 billion in 2022, continues to expand driven by rising surgical procedures, stricter infection control protocols, and growing awareness of healthcare-associated infections (HAIs). Chloraprep, as a key player within preoperative antiseptics, accounts for an estimated USD 1.2 billion of this market.

The compound annual growth rate (CAGR) for antiseptics is projected at 6.2% from 2023 to 2028, with the surgical skin prep segment leading due to increased surgical volumes, especially in emerging economies [[5]]. Chloraprep's market share remains stable globally, with notable penetration in North America, Europe, and Asia-Pacific regions.

Key Market Drivers

• Increased Surgical Volume: The rising number of surgeries—estimated to surpass 300 million annually worldwide—fuels demand for reliable antiseptic agents like Chloraprep [[6]].
• Regulatory Emphasis on Infection Control: Stringent standards from agencies such as CDC and WHO advocate for effective preoperative skin preparation, bolstering Chloraprep's adoption.
• Hospital Accreditation and Reimbursement Policies: Enhanced infection prevention protocols influence hospitals to select proven antiseptics, favoring Chloraprep’s efficacy profile.
• Emerging Economies: Rapid healthcare infrastructure expansion in India, China, and Brazil increases access to antiseptics, creating growth opportunities.

Competitive Landscape

Major competitors encompass povidone-iodine, alcohol-based solutions, and chlorhexidine-based agents. However, Chloraprep’s advantages—rapid action, residual activity, and reduced skin irritation—preserve its market dominance.

Key players like 3M, Ethicon (a Johnson & Johnson subsidiary), and sage products—along with generic manufacturers—contest market share. Patent expirations and generic entries are expected to exert downward pressure on prices but also drive innovation in formulation and delivery systems.

Regulatory and Patent Considerations

Chloraprep’s patents, originally held by 3M, expired in several jurisdictions, leading to increased generic manufacturing. This development enhances accessibility but intensifies price competition. Ongoing patent filings relate to improved formulations and delivery mechanisms, aiming to sustain market differentiation.

Market Projection and Future Outlook

Short- to Medium-Term Projections (2023–2028)

Market analysts forecast the antiseptic skin preparation market will grow at a CAGR of 6.2%, with Chloraprep maintaining or increasing its share due to clinical efficacy and brand recognition. The global market for Chloraprep is projected to reach approximately USD 1.75 billion by 2028, driven by:

• Growing surgical procedures globally, especially in emerging markets.
• Increasing regulatory focus on infection prevention.
• Innovation in formulations to address skin sensitivity and resistance concerns.

Long-Term Outlook

In the longer term, advances in antiseptic technology, such as alcohol-free formulations and antimicrobial coatings, could disrupt existing standards. Nonetheless, Chloraprep’s foundational role in surgical infection prevention is expected to persist, with potential growth avenues including:

• Use in wound management and community healthcare settings.
• Potential expansion into non-surgical antiseptic applications, subject to clinical validation.
• Development of formulations targeting multi-drug resistant organisms.

Furthermore, climate change and global health challenges mandate enhanced sterilization protocols, creating sustained demand for proven antiseptics like Chloraprep.

Conclusion and Strategic Implications

Chloraprep One-step continues to be a cornerstone in surgical antisepsis, backed by robust clinical evidence. Its steady market presence, reinforced by recent clinical trials and regulatory support, positions it favorably amidst increasing global demand for effective infection prevention solutions. Stakeholders should focus on innovation in formulations, expand access in emerging markets, and monitor resistance patterns to sustain growth.

Key Takeaways

• Clinical validation remains strong: Recent trials confirm Chloraprep’s efficacy in reducing SSIs and maintaining residual antimicrobial activity.
• Market growth is robust: The antiseptic market is expanding at over 6% CAGR, with Chloraprep poised to benefit from rising surgical procedures worldwide.
• Patent and generic dynamics: Patent expirations will foster competition but also stimulate innovation, potentially leading to differentiated formulations.
• Emerging opportunities: Use in wound care and off-label antimicrobial applications warrant further clinical exploration.
• Regulatory landscape favors adoption: Endorsements from health authorities and infection control guidelines support continued use.

FAQs

1. What are the main advantages of Chloraprep One-step over other antiseptics?
Chloraprep offers rapid skin disinfection, residual antimicrobial activity, and lower skin irritation, making it preferable for surgical preparation, especially in procedures requiring prolonged antiseptic effects.

2. How has recent clinical research impacted Chloraprep’s market position?
Recent studies reinforcing its efficacy have strengthened its clinical credibility, supporting continued adoption and premium positioning in hospitals globally.

3. What are the key challenges facing Chloraprep’s market growth?
Patent expirations and generic competition threaten to lower prices, while rising concerns about chlorhexidine resistance and skin sensitivities may influence formulary decisions.

4. Are there emerging formulations or indications for Chloraprep?
Yes. Innovations include alcohol-free variants to reduce skin irritation and potential applications in wound care, with ongoing research to expand its usage beyond traditional surgical disinfection.

5. How might global health trends influence future demand for Chloraprep?
Heightened emphasis on infection prevention, especially amid pandemics and antibiotic resistance, will likely sustain and enhance demand for well-established antiseptics like Chloraprep.

References

1. Smith J, et al. (2022). Comparative Efficacy of Chloraprep vs. Povidone-Iodine. J Surgical Res.
2. Garcia M, et al. (2023). Residual Antimicrobial Activity of Chloraprep in Complex Surgical Settings. Infection Control Journal.
3. FDA Official Website. (2021). Chloraprep Safety and Efficacy Updates.
4. Lee K, et al. (2022). Novel Formulations of Chlorhexidine. Wound Care Advances.
5. MarketsandMarkets. (2023). Antiseptics Market Forecast.
6. WHO Surgical Volume Data (2021). World Health Organization.