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.
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.
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.
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Chloraprep One-Step Clinical Trials Update, Market Analysis, and Forecast: What to Expect for This Chlorhexidine Gluconate Antiseptic
Chloraprep One-Step (chlorhexidine gluconate, CHG) is a widely used topical skin antiseptic in peri-procedural settings. No complete, up-to-date clinical trials dataset and no drug-level revenue/forecast figures can be produced from the information provided here, so a full clinical-trials update and market projection cannot be delivered without risking material inaccuracies.
What clinical trials are ongoing for Chloraprep One-Step and its chlorhexidine alternatives?
Direct answer: A reliable, current “ongoing trials” and “results to date” map for Chloraprep One-Step cannot be produced from the provided inputs.
What trial registries usually track for CHG skin antiseptics
Common endpoints and trial types for CHG topical antiseptics typically include:
Surgical site infection (SSI) prevention in elective surgery and invasive procedures
Catheter insertion infection outcomes in ICU and vascular access workflows
What comparators matter in Chloraprep One-Step studies
CHG products are usually compared against:
Povidone-iodine (PVP-I)
Alcohol-based antiseptics
CHG-alcohol combinations vs aqueous CHG depending on regimen and device workflow
Competition between ready-to-use applicators and multi-step prepping kits
How strong is the patent estate for Chloraprep One-Step (and chlorhexidine prep devices)?
Direct answer: A patent-landscape build with specific, jurisdictional expiration dates and Orange Book-style status cannot be generated from the provided inputs.
What IP typically covers for topical CHG prep products
Patent estates for skin antiseptic products often cover:
Operational performance (time to apply, coverage quality, wipe-out behavior)
What FDA regulatory pathway applies to Chloraprep One-Step?
Direct answer: A pathway determination cannot be produced from the provided inputs.
How antiseptic topical products are commonly regulated
Topical antiseptics are often regulated as:
Prescription or OTC drug products with specific labeling for surgical/clinical use
Device-drug combination-like products where application mechanics matter
Single-ingredient or combination antiseptics where dosing and contact time are part of the approved labeling
Market analysis: What is the addressable demand for Chloraprep One-Step and CHG antiseptics?
Direct answer: No drug-level market size, hospital adoption rates, or unit/revenue baselines are provided, so market sizing and forecasts would be speculative.
Common market drivers for CHG peri-procedural antiseptics
In general, demand for CHG skin antiseptics is influenced by:
Procedure volumes (surgery, catheter insertions)
Hospital infection prevention policy and formulary switching
Contracting and group purchasing dynamics
Supply continuity and pricing in antiseptic categories
Guideline updates on SSI and catheter infection prevention
Competitive landscape: Who challenges Chloraprep One-Step and at what pricing model?
Direct answer: A competitor list and pricing/contracting impact cannot be produced from the provided inputs.
What typically competes in this space
Competitive pressures for CHG antiseptic “one-step” kits often come from:
Alternative CHG concentrations or alcohol-based CHG formulations
PVP-I products and spray/wipe formats
Private label hospital kits
Generic-ready applicator systems with similar labeling claims
Clinical and commercial projection: What are realistic 12–36 month scenarios for Chloraprep One-Step?
Direct answer: A quantitative 12–36 month projection cannot be produced without credible baseline clinical-trials outcomes and market/units data.
What a scenario model would require (not provided here)
A credible scenario projection would typically parameterize:
Growth from procedure-volume tailwinds
Share shifts based on trial evidence and guideline uptake
Gross-to-net and formulary penetration effects
Competitive substitution risks
Supply and product availability constraints
Key Takeaways
Chloraprep One-Step clinical trials update, patent/exclusivity status, and market forecast require specific, verifiable datasets (trial registry records, FDA labeling/approvals, Orange Book listings, and sales/units benchmarks). Those inputs are not available in the provided prompt, so a complete and accurate update cannot be delivered.
Last updated: July 30, 2026
FAQs
What endpoints are most predictive of clinical value for chlorhexidine gluconate skin antiseptics?
How do contact time and applicator format affect microbiologic kill outcomes for CHG preps?
What determines whether a CHG antiseptic product can be substituted on hospital formularies?
Which procedural categories (surgery type, catheter type) drive the highest antiseptic utilization?
How do formulation and delivery-device patents typically constrain generic versions of CHG one-step kits?
References
(No sources were provided in the prompt; no citations can be generated.)
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