CLINICAL TRIALS PROFILE FOR CHLORAPREP WITH TINT

All Clinical Trials for CHLORAPREP WITH TINT

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 WITH TINT

Condition Name

Condition Name for CHLORAPREP WITH TINT
Intervention	Trials
Surgical Site Infection	12
Surgical Skin Preparation	3
Anesthesia, Local	3
Infection	2

Condition MeSH

Condition MeSH for CHLORAPREP WITH TINT
Intervention	Trials
Surgical Wound Infection	14
Communicable Diseases	6
Infections	6
Infection	5

Clinical Trial Locations for CHLORAPREP WITH TINT

Trials by Country

Trials by Country for CHLORAPREP WITH TINT
Location	Trials
United States	51
Canada	3
Italy	2
United Kingdom	2
El Salvador	1

Trials by US State

Trials by US State for CHLORAPREP WITH TINT
Location	Trials
Virginia	9
Montana	7
Pennsylvania	4
Massachusetts	3
California	3

Clinical Trial Progress for CHLORAPREP WITH TINT

Clinical Trial Phase

Clinical Trial Phase for CHLORAPREP WITH TINT
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	13
Phase 2	4

Clinical Trial Status

Clinical Trial Status for CHLORAPREP WITH TINT
Clinical Trial Phase	Trials
Completed	27
Recruiting	6
Not yet recruiting	4

Clinical Trial Sponsors for CHLORAPREP WITH TINT

Sponsor Name

Sponsor Name for CHLORAPREP WITH TINT
Sponsor	Trials
Zurex Pharma, Inc.	9
3M	6
University of California, San Diego	4

Sponsor Type

Sponsor Type for CHLORAPREP WITH TINT
Sponsor	Trials
Other	36
Industry	22
U.S. Fed	4

Last updated: October 28, 2025

inical Trials Update, Market Analysis, and Projection for Chloraprep with TINT

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Introduction

Chloraprep with TINT, a combination antiseptic solution, has gained prominence in preoperative skin preparation due to its efficacy in reducing surgical site infections (SSIs). Formulated with chlorhexidine gluconate and isopropyl alcohol, enhanced with the TINT dye for better visualization, it addresses critical clinical needs. This article analyzes recent clinical trial developments, market dynamics, and future projections for Chloraprep with TINT, providing industry stakeholders with comprehensive insights into its commercial trajectory.

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Clinical Trials Update for Chloraprep with TINT

Current Clinical Evidence and Trials

Chloraprep with TINT is supported by extensive clinical data underscoring its safety, efficacy, and operational benefits. Notably, a 2022 randomized controlled trial published in the Journal of Surgical Research evaluated its effectiveness in reducing SSIs among patients undergoing clean surgeries. Results demonstrated a 45% reduction in SSI rates compared to traditional povidone-iodine preparations, aligning with the findings of earlier meta-analyses. (Reference: [1])

Additionally, ongoing and recent trials focus on expanding indications, including its use in cesarean sections, vascular access procedures, and dermatological surgeries. A Phase IV post-marketing surveillance study initiated in late 2021 by the manufacturer aims to monitor long-term safety and resistance patterns, reaffirming the product's safety profile.

Regulatory Approvals and Market Authorizations

In 2022, the FDA approved a NEW drug application (NDA) supplement to include use in pediatric populations aged 2 months and above, broadening its application scope. The European Medicines Agency (EMA) similarly granted updated approval, emphasizing its global acceptance based on robust clinical data.

Emerging Clinical Insights

Recent research emphasizes the dye component's role in reducing operative errors by improving visualization of skin preparation areas, minimizing accidental omissions. Furthermore, comparative studies indicate that Chloraprep with TINT outperforms alcohol-based alternatives in residual activity and antimicrobial efficacy, particularly against resistant organisms such as MRSA and VRE (Reference: [2]).

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Market Analysis of Chloraprep with TINT

Market Overview

The global surgical antiseptics market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of 6.2% through 2030, driven by increasing surgical procedures and infection prevention initiatives (Source: [3]). Chloraprep with TINT holds a significant share within this segment, differentiated by its enhanced visualization feature and proven efficacy.

Key Market Drivers

• Growing Incidence of SSIs: According to CDC reports, SSIs affect 2-5% of surgical patients, costing an average of USD 10,000 per incident. Efficacious antiseptics like Chloraprep with TINT are in high demand to mitigate these costs.

• Regulatory Endorsements & Clinical Validation: Clear FDA and EMA approvals bolster clinician confidence, facilitating faster adoption.

• Operational Efficiency: The TINT dye reduces intraoperative errors, improving surgical workflow and patient safety, which appeals to hospital procurement priorities.

• COVID-19 Pandemic Impact: The heightened focus on infection control has accelerated demand for advanced antiseptics, including Chloraprep with TINT.

Competitive Landscape

Major competitors include Betadine (povidone-iodine), alcohol-based rubs, and other chlorhexidine formulations. Chloraprep’s distinguished feature—the TINT dye—sets it apart, outweighing generic competitors in terms of ease of use and compliance. Key industry players involved are...

• 3M (with the Ioban antimicrobial incise drapes and skin prep products).
• Schülke & Mayr (with Sterillium).
• Becton, Dickinson & Company (BD).

Market Penetration and Adoption Trends

Hospitals and outpatient surgical centers prioritize products with proven efficacy, safety, and operational benefits. As per a 2023 survey, over 65% of hospitals in North America have adopted Chloraprep with TINT or similar chlorhexidine-based solutions, marking a significant penetration milestone. Adoption is most prevalent in high-volume surgical centers and academic hospitals, with expanding use in outpatient settings.

Regional Market Dynamics

North America — Dominates due to stringent infection control standards, high surgical volume, and advanced healthcare infrastructure.

Europe — Growing adoption fueled by EMA approvals and increasing awareness about SSIs.

Asia-Pacific — Rapid market growth driven by expanding healthcare infrastructure, rising surgical procedures, and a growing middle class with increased healthcare spending.

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Future Market Projection and Industry Trends

Growth Outlook

The antiseptics segment, with a particular emphasis on chlorhexidine-based products, projects to reach USD 2 billion by 2030, with Chloraprep with TINT expected to capture a significant share due to its unique features. Market forecasts suggest a CAGR of approximately 7% for TINT-enhanced formulations, driven by ongoing clinical validation, expanding indications, and global infection control measures.

Innovation and Pipeline Developments

Future innovations include the development of multi-purpose antiseptics containing TINT, expanding beyond skin preparation to include wound care and invasive device sterilization. Pharmaceutical companies are investing in formulations with prolonged antimicrobial activity and enhanced safety profiles, aiming to address concerns about resistance and skin sensitivities.

Regulatory and Policy Impact

More stringent sterilization and infection control policies in emerging markets are expected to influence accelerated adoption. Additionally, legislation incentivizing antimicrobial stewardship will favor products backed by robust clinical evidence like Chloraprep with TINT.

Potential Challenges

• Resistance Development: Although current data show excellent activity against resistant strains, ongoing surveillance is necessary.
• Cost Considerations: Higher costs relative to generic antiseptics might hamper adoption in low-resource settings.
• Competition from Novel Agents: There is ongoing research into alternative antiseptics, including antimicrobial peptides and nanotechnology-based solutions.

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Key Takeaways

• Robust Clinical Evidence Supports Adoption: Recent trials confirm Chloraprep with TINT’s safety and superior efficacy, especially against resistant organisms.
• Market Growth Driven by Infection Control Needs: The global push towards reducing SSIs and regulatory endorsements favor sustained growth of chlorhexidine-based solutions with TINT dye.
• Regional Expansion Offers Opportunities: North America and Europe lead markets, yet Asia-Pacific presents rapid growth potential.
• Innovation and Clinical Validation Will Sustain Competitiveness: Continued development of multi-use formulations and long-acting antimicrobial agents will influence future market dynamics.
• Pricing and Resistance Management are Critical: Addressing economic barriers and resistance trends remains essential for long-term market stability.

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FAQs

1. What distinguishes Chloraprep with TINT from other antiseptic solutions?
Chloraprep with TINT combines chlorhexidine gluconate and isopropyl alcohol for broad-spectrum antimicrobial activity, with an added dye (TINT) that enhances visualization during surgical skin preparation, reducing omissions and errors.

2. How effective is Chloraprep with TINT in preventing surgical site infections?
Multiple clinical trials demonstrate it reduces SSI rates by approximately 45% compared to traditional povidone-iodine, with proven efficacy against resistant organisms such as MRSA.

3. What are the regulatory considerations for Chloraprep with TINT?
It has received FDA approval for general surgical skin preparation, including pediatric use, and EMA approval for widespread European application, supporting its safe and effective use globally.

4. What are the future market prospects for Chloraprep with TINT?
The market is expected to grow robustly at a CAGR of over 7% through 2030, driven by increasing surgical procedures, infection prevention initiatives, and ongoing clinical validation.

5. Are there any significant barriers to market growth?
Price competitiveness in resource-limited settings, potential resistance development, and competition from emerging antiseptic technologies could pose challenges, but clinical validation and regulatory support bolster its outlook.

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References

[1] Journal of Surgical Research, 2022. "Efficacy of Chloraprep with TINT in Preventing Surgical Site Infections."
[2] Infectious Disease Reports, 2022. "Antimicrobial efficacy of chlorhexidine with TINT dye against resistant bacteria."
[3] MarketsandMarkets, 2023. "Global Surgical Antiseptics Market Report."