Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR CHLORAPREP WITH TINT


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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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

Trials by Country for CHLORAPREP WITH TINT
Location Trials
United States 51
Canada 3
United Kingdom 2
Italy 2
Thailand 1
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Trials by US State

Trials by US State for CHLORAPREP WITH TINT
Location Trials
Virginia 9
Montana 7
Pennsylvania 4
California 3
Wisconsin 3
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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
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for CHLORAPREP WITH TINT
Sponsor Trials
Zurex Pharma, Inc. 9
3M 6
CareFusion 4
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Sponsor Type

Sponsor Type for CHLORAPREP WITH TINT
Sponsor Trials
Other 36
Industry 22
U.S. Fed 4
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Last updated: July 28, 2026

Chloraprep With Tint clinical trials update, market analysis and revenue projection

Executive summary

Chloraprep With Tint is an alcohol-based skin antiseptic product used for pre-injection/pre-procedure skin preparation. Public, verifiable details needed for a complete clinical-trials update, current-market sizing, and forward revenue projection (trial identifiers, latest regulatory status, sales data, distribution, pricing, and patent/exclusivity constraints) are not provided in the prompt. No market model can be produced without those hard inputs.

What clinical trials are ongoing or completed for Chloraprep With Tint?

No trial registry identifiers, study dates, endpoints, or results are included in the input. A clinical trials update requires specific evidence such as ClinicalTrials.gov record numbers or published study citations.

Which endpoints does Chloraprep With Tint trials measure (bacterial kill, contamination reduction, safety)?

A trials update is not possible without study-level endpoints and results.

Are there new data on efficacy versus standard chlorhexidine or povidone-iodine comparators?

No comparator details or study results are provided.

What is the latest FDA status for Chloraprep With Tint (ANDA, 505(b)(2), OTC vs prescription, labeling changes)?

The prompt does not include FDA pathway, approval date, NDA/BLA number, exclusivity status, or labeling revision history. An Orange Book style status check is not possible without the relevant application reference.

What does the Orange Book list for Chloraprep With Tint?

No Orange Book listing, applicant, NDA number, or patent numbers are provided.

Has the product had any REMS, safety communications, or major labeling updates?

No labeling or post-marketing safety artifact details are included.

How big is the market for pre-procedural skin antiseptics like Chloraprep With Tint?

No market scope is defined (US only vs global; hospital vs ambulatory; antiseptic category definitions), and no sales, channel mix, or geography is provided. Market projection cannot be constructed without at least one anchor metric.

Hospital versus ambulatory share for skin antiseptics

No channel split is provided.

What share is held by chlorhexidine-alcohol skin preps versus povidone-iodine and iodophors?

No competitive share figures are provided.

Which companies compete with Chloraprep With Tint, and what are their commercial headwinds or tailwinds?

No competitor set, product names, distribution footprint, or contracting status (GPO, IDN systems, formularies) is included.

How does Chloraprep With Tint compare with competitors on adoption drivers (application system, contact time, staining/tint benefits, cost)?

No product-spec or pricing/contracting evidence is provided.

What generic or interchangeable risks exist for Chloraprep With Tint?

No regulatory interchangeability or generic entry history is provided.

When does Chloraprep With Tint lose exclusivity, and how does that affect generic or OTC entry risk?

The prompt provides no patent numbers, expiration dates, exclusivity periods, or regulatory reference product details. A timing analysis requires those specific dates.

What patents protect Chloraprep With Tint (composition, method-of-use, applicator or solution characteristics)?

No patent estate information is provided.

What Paragraph IV challenges affect Chloraprep With Tint?

No certification litigation or ANDA challenge history is provided.

What formulation and delivery system claims apply to Chloraprep With Tint (tint, applicator type, stability)?

No formulation identifiers, strength, or delivery-system specifications are included in the input.

Does the “With Tint” coloring drive differentiation in hospitals (workflow, contamination visibility, training)?

No adoption evidence is provided.

What is the revenue projection for Chloraprep With Tint over the next 3 to 7 years?

A revenue projection requires at minimum: baseline sales, growth rates, volume assumptions, price trajectory, reimbursement/contracting assumptions, and competitive dynamics, none of which are provided.

Base case, downside, and upside scenarios for Chloraprep With Tint

No baseline or sensitivity inputs are provided.

Forecast drivers for growth (procedure volumes, hospital penetration, replacement cycles)

No quantitative drivers are provided.

Forecast risks (substitution, formulary exclusions, new antiseptic entrants, safety signals)

No evidence-based risk triggers are provided.

Key Takeaways

  • A credible clinical-trials update cannot be produced without trial identifiers and published/registered outcomes for Chloraprep With Tint.
  • A credible market analysis and revenue projection cannot be produced without an evidentiary anchor for sales and a defined market scope, pricing, channel mix, and competitive set.
  • Patent/exclusivity and generic-risk timing cannot be produced without patent numbers, Orange Book entries, and exclusivity dates.

FAQs

  1. What ClinicalTrials.gov records mention “Chloraprep With Tint” and what were the most recent results?
  2. What NDA or 505(b)(2) application supports Chloraprep With Tint, and what is the latest FDA label revision date?
  3. What Orange Book patents list against Chloraprep With Tint, and what are their expiration dates?
  4. What evidence compares Chloraprep With Tint efficacy against povidone-iodine or chlorhexidine alternatives in randomized studies?
  5. What hospital contracting patterns (GPO/IDN formularies) most influence Chloraprep With Tint penetration and switching?

References

No sources were provided in the prompt, and no verifiable external citations can be generated from the given input.

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