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.
NCT00739583 ↗	Visibility of Site Marking for Surgical Time Out With Two Different Skin Preparation Solutions	Completed	Johns Hopkins University	Phase 4	2008-08-01	Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.

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	50
Canada	3
Italy	2
United Kingdom	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	5
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	35
Industry	22
U.S. Fed	4

CHLORAPREP ONE-STEP SEPP: Clinical Trials, Market Analysis, and Projections

Introduction

CHLORAPREP ONE-STEP SEPP, a skin antiseptic solution, is a crucial product in the medical field, particularly for preoperative skin preparation and reducing the risk of skin infections. This article will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

CHLORAPREP ONE-STEP SEPP, containing 2% chlorhexidine gluconate and 70% isopropyl alcohol, has undergone several clinical trials to evaluate its efficacy and safety.

• Reduction in Infections: Studies have shown that the use of CHLORAPREP ONE-STEP significantly reduces the risk of central line-associated bloodstream infections (CLABSI) and catheter-related bacteremia (CRB). For instance, a prospective randomized clinical trial found that using 2% chlorhexidine gluconate prior to central venous catheter (CVC) insertion and maintenance reduced the risk of infection by up to 70% compared to povidone-iodine solutions[4].
• Skin Preparation: The product has been proven effective in skin preparation prior to surgery, reducing bacterial counts more efficiently than multi-step processes involving povidone-iodine and isopropyl alcohol[4].
• Safety Profile: Clinical trials have indicated that CHLORAPREP ONE-STEP has a favorable safety profile, with minimal systemic absorption of chlorhexidine gluconate and isopropyl alcohol, and no significant reports of skin irritation[3][4].

Market Analysis

The market for skin antiseptic products, including CHLORAPREP ONE-STEP, is growing steadily.

• Global Market Size: The global skin antiseptic products market was valued at USD 3.42 billion in 2024 and is projected to reach USD 6.50 billion by 2034, growing at a CAGR of 6.64% from 2024 to 2034[2].
• Regional Dominance: North America is the largest market for skin antiseptic products, driven by advanced healthcare infrastructure and high demand for effective antiseptic solutions[2].
• Competitive Landscape: CHLORAPREP ONE-STEP, marketed by Becton Dickinson Co, holds a significant position in the market due to its one-step application process and enhanced efficacy compared to other antiseptic solutions[1].

Market Projections

Given the growing demand for effective skin antiseptic solutions and the proven efficacy of CHLORAPREP ONE-STEP, several projections can be made:

• Increased Adoption: The convenience and efficacy of CHLORAPREP ONE-STEP are likely to increase its adoption in various healthcare settings, including hospitals, surgical centers, and long-term care facilities.
• Expansion into New Markets: As the global healthcare landscape evolves, there is potential for CHLORAPREP ONE-STEP to penetrate new markets, particularly in regions with developing healthcare infrastructures.
• Innovation and Brand Extensions: Becton Dickinson Co may explore brand extensions or new formulations to further enhance the product's market position and address emerging needs in the antiseptic market[1].

Patent and Regulatory Status

CHLORAPREP ONE-STEP is protected by one US patent and has twelve patent family members in eleven countries. This intellectual property protection helps maintain its market position.

• Regulatory Approval: The product has been approved under a New Drug Application (NDA) and is classified as a non-sterile solution for professional use only[5].
• Patent Expiration: The patent protection for CHLORAPREP ONE-STEP will expire in the future, but the exact dates are not publicly disclosed. This could potentially open up the market to generic competitors once the patents expire[1].

Key Takeaways

• Efficacy: CHLORAPREP ONE-STEP has been proven to significantly reduce the risk of skin infections and is more effective than multi-step antiseptic processes.
• Market Growth: The global skin antiseptic products market is growing, with North America being the largest market.
• Market Position: CHLORAPREP ONE-STEP holds a strong market position due to its one-step application and enhanced efficacy.
• Future Projections: The product is likely to see increased adoption and potential expansion into new markets.

FAQs

What are the active ingredients in CHLORAPREP ONE-STEP?

The active ingredients are 2% chlorhexidine gluconate and 70% isopropyl alcohol[5].

What is the primary use of CHLORAPREP ONE-STEP?

The primary use is for patient preoperative skin preparation to reduce bacteria that can cause skin infections[5].

How does CHLORAPREP ONE-STEP compare to other antiseptic solutions?

CHLORAPREP ONE-STEP is more effective and convenient than multi-step processes involving povidone-iodine and isopropyl alcohol, reducing bacterial counts more efficiently[4].

What is the global market size projection for skin antiseptic products by 2034?

The global skin antiseptic products market is projected to reach USD 6.50 billion by 2034[2].

Is CHLORAPREP ONE-STEP protected by patents?

Yes, CHLORAPREP ONE-STEP is protected by one US patent and has twelve patent family members in eleven countries[1].

Sources

1. Drug Patent Watch: CHLORAPREP ONE-STEP Drug Patent Profile.
2. Precedence Research: Skin Antiseptic Products Market Size to Hit USD 6.50 Bn by 2034.
3. FDA: Center for Drug Evaluation and Research - NDA 208288.
4. BD: ChloraPrep™ Clinical Evidence Compendium.
5. DailyMed: Chlorhexidine gluconate and isopropyl alcohol solution - CHLORAPREP ONE-STEP.