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.

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
United Kingdom	2
Italy	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

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

Last updated: April 28, 2026

What is Chloraprep One-step in the product and regulatory context?

Chloraprep One-step is a single-use topical skin antisepsis product containing chlorhexidine gluconate (CHG) in a one-step applicator intended to reduce skin microbes before invasive procedures. The commercial positioning is typically as a ready-to-use device for pre-procedure skin preparation, replacing multi-step prep workflows in hospitals and ambulatory settings.

Regulatory and labeling scope

• The product is marketed as an antiseptic skin preparation under medical product regulatory frameworks that vary by jurisdiction (US FDA over-the-counter antiseptic drug/device classifications and EU/UK frameworks for medical products).
• Market access is driven by hospital formulary acceptance, conversion from legacy CHG or povidone-iodine workflows, and procurement outcomes rather than classic “drug efficacy trial” headlines.

What clinical trials data support Chloraprep One-step adoption?

A clinical trials “update” for Chloraprep One-step typically does not function like a late-stage oncology or rare disease pipeline asset. The core clinical evidence usually supports:

• Antiseptic effectiveness on skin microorganisms
• Safety (local reactions, tolerability)
• Workflow usability (time-to-apply, contamination risk during preparation)
• Comparative performance against alternative skin prep regimens (often povidone-iodine or alcohol-containing antiseptics depending on comparator arms)

However, no sufficiently specific, product-level trial dataset for “Chloraprep One-step” itself (as opposed to broader chlorhexidine skin preparation categories or legacy CHG formulations) is provided in the available information in this session. Under strict completeness rules, a precise trials update with study identifiers, endpoints, and readouts cannot be produced without risking inaccurate attribution.

Where does Chloraprep One-step sit in the competitive landscape?

Chloraprep One-step competes in the “pre-procedure skin antisepsis” category dominated by:

• CHG-based skin prep products (single-use applicators and swabs)
• Povidone-iodine preparations (solutions/swabs in similar workflows)
• Competing multi-step or device-based antiseptic delivery systems (depending on market)

Competition is shaped by:

• Protocol mandates (hospital infection prevention programs)
• Product standardization across OR, ED, procedural suites, and device-implant pathways
• Tender price pressure and conversion costs during formulary updates
• Evidence of microbial reduction and residual activity under real-world constraints (wetness control, coverage consistency)

What is the market sizing logic for Chloraprep One-step?

Market forecasting for skin antisepsis products is usually built from:

1. Procedure volume pool (surgical and invasive procedure counts)
2. Universal precautions penetration (adoption of standardized skin antisepsis protocols)
3. Device conversion rate (share using single-use applicators versus other formats)
4. Price realization (ASP trends under procurement)
5. Hospital vs ambulatory mix shift

A product-specific projection requires:

• Category market size and growth drivers
• Chloraprep’s brand share and conversion trajectory
• Competitive displacement dynamics (especially CHG vs non-CHG)
• Regional regulatory and guideline effects

No validated market-share inputs, brand share series, region-specific volumes, or ASP series are available in the provided information in this session, so a numeric projection would be speculative and cannot be stated as “market analysis and projection” with hard data.

What demand drivers and payer/procurement forces influence uptake?

Demand is tied to infection prevention and procurement mechanics:

• Hospital-acquired infection (HAI) reduction programs drive standardized antisepsis protocols.
• Guideline and stewardship efforts favor products with demonstrable microbial reduction performance and operational reliability.
• Tendering often favors CHG-based regimens when they meet formulary criteria and procurement economics.
• Labor efficiency matters: single-use, one-step application reduces preparation variance and training burden.

What constraints cap upside in the forecast?

Upside is capped by:

• Price compression as procurement cycles renew and competitors match spec claims
• Variation in local formularies and protocol acceptance across hospital networks
• Clinical practice friction: staff adoption of new applicator formats and local protocol compliance

Is there patent or exclusivity risk that impacts commercial duration?

A full patent and exclusivity analysis requires a product-specific legal file: US Orange Book entries (if applicable), EP disclosures, WO family scope, and device/drug combination coverage. No patent dataset or legal status information is provided in this session.

Under the strict rules for complete accuracy, exclusivity conclusions cannot be issued here.

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Clinical trials update: what would be required for a complete readout?

A complete update would typically include:

• Trial identifiers (NCT/ISRCTN/EudraCT)
• Study design (randomized, comparator, number of sites)
• Population (procedure type, setting, inclusion criteria)
• Endpoints (CFU reduction, contamination, infection outcomes)
• Readouts and timelines (interim/final)
• Safety outcomes (local irritation, hypersensitivity)

No such product-specific trial record is included in this session’s information.

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Market analysis and projection: what inputs define a hard forecast?

A complete projection requires:

• Category market size by geography and setting
• Brand share and conversion trends
• Unit volume (procedures multiplied by applicator usage rate)
• ASP and gross-to-net effects under contracting
• Share shifts versus povidone-iodine and other antiseptic platforms

No numeric inputs are present in this session.

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Key Takeaways

• Chloraprep One-step is positioned as a single-use CHG-based skin antisepsis product for pre-procedure preparation.
• A product-level clinical trials update cannot be accurately enumerated here without a specific study dataset for “Chloraprep One-step” itself.
• A numeric market analysis and projection cannot be produced with hard data without category size, brand share, ASP, and unit volume inputs.
• Commercial dynamics are procurement-led: protocol adoption, conversion from legacy formats, and tender economics determine growth more than incremental clinical readouts.

FAQs

1. What antiseptic active ingredient does Chloraprep One-step use?
   It uses chlorhexidine gluconate (CHG) as the skin antiseptic active.

2. Is Chloraprep One-step a late-stage drug pipeline product?
   No. It is a skin antisepsis product, and evidence and adoption typically hinge on antiseptic effectiveness, safety, and workflow conversion rather than late-stage clinical endpoints.

3. What drives hospital adoption for pre-procedure skin antiseptics?
   Infection prevention protocols, formulary standardization, and procurement tender outcomes.

4. What usually limits growth for CHG antiseptic applicators?
   Price compression and formulary switching friction across hospital networks.

5. Can exclusivity and patent life be assessed without legal status data?
   No. A credible exclusivity assessment requires a product-specific patent and regulatory exclusivity record.

References

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