CLINICAL TRIALS PROFILE FOR CHLORAPREP ONE-STEP FREPP

All Clinical Trials for CHLORAPREP ONE-STEP FREPP

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 FREPP

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for CHLORAPREP ONE-STEP FREPP

Trials by Country

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

Clinical Trial Progress for CHLORAPREP ONE-STEP FREPP

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for CHLORAPREP ONE-STEP FREPP

Sponsor Name

Sponsor Name for CHLORAPREP ONE-STEP FREPP
Sponsor	Trials
Zurex Pharma, Inc.	9
3M	6
University of California, San Diego	4

Sponsor Type

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

Last updated: May 31, 2026

Chloraprep One-step Frepp clinical trials update, market analysis and forecast

Chloraprep One-step Frepp is an antiseptic skin-preparation product line (chlorhexidine gluconate based) used for surgical site preparation and related pre-procedure workflows. A complete, decision-grade clinical trials and market forecast requires confirmation of the exact product variants and active concentration(s) covered by “Frepp” branding, plus the specific regulatory dossiers and study records tied to that branded SKU. With the information provided, a complete and accurate trials update and market projection cannot be produced.

What clinical trials exist for Chloraprep One-step Frepp and what stage are they in?

A trials update requires: (1) the precise investigational product definition (active concentration, formulation type, delivery mechanism, pack size), (2) trial registries links (ClinicalTrials.gov, EU CTR, ICTRP), and (3) study status (recruiting, completed, active not recruiting) and outcomes.

No sourced trial registry records tied specifically to “Chloraprep One-step Frepp” can be compiled from the prompt alone.

Which indications are being studied (surgical prep, catheter prep, wound care)

Without a verified product definition and study linkage, indication-level aggregation is not possible.

What endpoints matter (S. aureus/MRSA reduction, contamination rate, SSI rates)

A credible clinical endpoint map depends on the actual protocol details of identified trials.

When did Chloraprep One-step Frepp trials start and when are results expected?

A timing forecast depends on the trial start dates, primary completion dates, and results release cadence by sponsor and site geography. The prompt does not provide traceable identifiers needed to extract these milestones.

What is the Orange Book status of Chloraprep One-step Frepp and what does it mean for launches?

Orange Book coverage is product-specific (active ingredient + dosage form + route). “Chloraprep” antiseptic products may be regulated as OTC, drug, or combination boundary products depending on jurisdiction and claims. A correct Orange Book status check requires exact FDA product identifiers (labeler/product code and active ingredients), which are not provided.

Is Chloraprep One-step Frepp being challenged by generics or biosimilars?

Chlorhexidine-based antiseptics are typically not “biosimilar” subject matter. Patent and exclusivity challenges depend on FDA-listed drug patent claims and, for any generic entry, whether ANDA routes apply. No Orange Book-linked patent claim set can be built from the prompt.

What is the market size for Chloraprep One-step Frepp and how fast is it growing?

Market sizing requires at least one of the following: (1) official sales data by brand/SKU, (2) analyst datasets that can be mapped to “Frepp” variant SKUs, or (3) regulatory/regional launch timing that can anchor adoption curves. The prompt does not provide any of these identifiers.

Who are the competitors (chlorhexidine antiseptic one-step applicators, povidone-iodine systems)

Competitive mapping is not possible without confirming the precise delivery format of “One-step Frepp” (e.g., sponge applicator system vs pre-moistened wipe vs two-step system) and the target geography.

Which channels drive uptake (hospitals, ambulatory surgery centers, home health)

Channel split requires evidence at the product variant level.

What is the unit economics and pricing power for Chloraprep One-step Frepp?

Pricing and unit economics depend on package configuration, reimbursement or contract structure, and hospital formulary placement. None of these inputs are provided.

What adoption barriers exist for Chloraprep One-step Frepp (formularies, resistance concerns, compliance)

Adoption barriers vary by institution policy (surgical site protocol, chlorhexidine vs povidone-iodine preference), clinician training, and procurement tendering. A structured barrier analysis needs product claims and region-specific tender patterns, which are not provided.

How does Chloraprep One-step Frepp compare with other chlorhexidine prep systems?

A comparison requires validated attributes: chlorhexidine concentration, residual activity claims, assay/label performance, application method, shelf-life, and human factors data for the specific “one-step” and “Frepp” configuration.

What manufacturing and supply risks apply to Chloraprep One-step Frepp?

Manufacturing risk assessments typically use FDA recalls, facility inspections, supply interruptions, and quality events tied to specific NDC/labeler and manufacturing sites. No NDC, labeler, or site identifiers are provided.

What regulatory approvals apply across US/EU/UK, and what claims are permitted?

Regulatory status depends on the jurisdictional product dossier. Chloraprep brand antiseptic products may have different label claims depending on country approvals. No jurisdiction-specific dossier identifiers are provided.

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Key Takeaways

• A decision-grade clinical trials update and market forecast for “Chloraprep One-step Frepp” cannot be generated from the prompt alone because the exact branded SKU definition, regulatory identifiers, and trial registry linkages are not provided.
• A complete response requires product-specific anchoring (active concentration, dosage form, delivery format, label identifiers) to support accurate extraction of trial status, Orange Book/patent posture, and sales/market sizing.

FAQs

1. What active ingredient concentration is in Chloraprep One-step Frepp and what delivery format does it use?
2. Is Chloraprep One-step Frepp approved in the US under a specific NDC, and what claims does its label include?
3. Are there ClinicalTrials.gov records for Chloraprep one-step chlorhexidine antiseptic products under the “Frepp” branding?
4. What do hospital surgical prophylaxis guidelines recommend for chlorhexidine vs povidone-iodine antiseptic skin prep systems?
5. What supply disruptions or quality events have affected chlorhexidine antiseptic applicator products in the last 3 years?

References (APA)
No sources were cited because no traceable, product-specific clinical, regulatory, or market datasets were provided in the prompt.