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Last Updated: July 10, 2025

CLINICAL TRIALS PROFILE FOR CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL


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505(b)(2) Clinical Trials for Chlorhexidine Gluconate; Isopropyl Alcohol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed Pacira Pharmaceuticals, Inc Phase 1 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed University of California, San Diego Phase 1 2012-02-01 EXPARELâ„¢, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Chlorhexidine Gluconate; Isopropyl Alcohol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00247897 ↗ Comparing Skin Disinfectants Before Labour Epidural Analgesia Completed University of British Columbia N/A 2005-11-01 The purpose of this study is to compare the current standard skin disinfectant solution for labour epidurals used at BC Women's Hospital to another common skin disinfectant and to the skin disinfectant solution recommended by the Public Health Agency of Canada (PHAC) prior to placing special intravenous lines. There is very little information available to guide doctors in deciding which is the best skin disinfectant for epidural analgesia. The study hypothesis is that the disinfectant solution recommended by the PHAC will be the most effective.
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.
NCT00829023 ↗ Efficacy of Surgical Preparation Solutions in Shoulder Surgery Completed CareFusion N/A 2007-06-01 The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
NCT00829023 ↗ Efficacy of Surgical Preparation Solutions in Shoulder Surgery Completed Northwestern University N/A 2007-06-01 The purpose of the present study was to examine the native bacteria around the shoulder and determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder.
NCT01216761 ↗ A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions Completed Blue Cross Blue Shield of Michigan Foundation N/A 2008-05-01 Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially. Objective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.
NCT01216761 ↗ A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions Completed University of Michigan N/A 2008-05-01 Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially. Objective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.
NCT01233050 ↗ Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery Completed 3M N/A 2010-12-01 Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Chlorhexidine Gluconate; Isopropyl Alcohol

Condition Name

Condition Name for Chlorhexidine Gluconate; Isopropyl Alcohol
Intervention Trials
Breast Surgery 3
Surgical Site Infection 2
Trauma Injury 2
Anesthesia, Local 2
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Condition MeSH

Condition MeSH for Chlorhexidine Gluconate; Isopropyl Alcohol
Intervention Trials
Infections 3
Communicable Diseases 3
Pain, Postoperative 3
Acute Pain 3
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Clinical Trial Locations for Chlorhexidine Gluconate; Isopropyl Alcohol

Trials by Country

Trials by Country for Chlorhexidine Gluconate; Isopropyl Alcohol
Location Trials
United States 17
Canada 3
United Kingdom 1
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Trials by US State

Trials by US State for Chlorhexidine Gluconate; Isopropyl Alcohol
Location Trials
California 7
Pennsylvania 2
Illinois 2
Wisconsin 1
Florida 1
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Clinical Trial Progress for Chlorhexidine Gluconate; Isopropyl Alcohol

Clinical Trial Phase

Clinical Trial Phase for Chlorhexidine Gluconate; Isopropyl Alcohol
Clinical Trial Phase Trials
Phase 4 12
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Chlorhexidine Gluconate; Isopropyl Alcohol
Clinical Trial Phase Trials
Completed 12
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for Chlorhexidine Gluconate; Isopropyl Alcohol

Sponsor Name

Sponsor Name for Chlorhexidine Gluconate; Isopropyl Alcohol
Sponsor Trials
University of California, San Diego 9
Northwestern University 2
University of Michigan 1
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Sponsor Type

Sponsor Type for Chlorhexidine Gluconate; Isopropyl Alcohol
Sponsor Trials
Other 26
Industry 4
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Chlorhexidine Gluconate and Isopropyl Alcohol: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction

Chlorhexidine gluconate (CHG) and isopropyl alcohol (IPA) are widely used antiseptic agents, particularly in medical settings for skin disinfection and infection prevention. This article delves into the clinical trials, market analysis, and future projections for these essential compounds.

Clinical Efficacy of Chlorhexidine Gluconate and Isopropyl Alcohol

Skin Disinfection and Catheter Colonization

Clinical trials have consistently shown the efficacy of CHG combined with IPA in reducing bacterial colonization and contamination. A study published on PubMed found that the addition of 2% CHG to 70% IPA significantly reduced the number of peripheral venous catheters that were colonized or contaminated[1].

Alternative Methods for Skin Disinfection

For individuals sensitive to chlorhexidine, alternative methods have been evaluated. A study by Canadian Blood Services compared the efficacy of ChloraPrep (2% CHG and 70% IPA) with a two-step method using 10% povidone-iodine followed by 70% IPA. The two-step method was found to be as effective as ChloraPrep, providing a viable alternative for chlorhexidine-sensitive donors[5].

Mechanism of Action

Chlorhexidine Gluconate

CHG is a biguanide compound that works by damaging the bacterial cell membrane, leading to the death of the bacteria. It provides a longer-lasting antibacterial effect compared to other disinfectants, making it a preferred choice for preoperative skin preparation and wound care[2].

Isopropyl Alcohol

IPA is a colorless, flammable chemical compound with a strong odor. It is commonly used in antiseptics, disinfectants, and detergents. IPA works by denaturing proteins and disrupting the cell membrane of microorganisms, thereby killing them. Its rapid evaporation also helps in reducing the moisture on the skin, which is essential for bacterial growth[3].

Market Analysis

Chlorhexidine Gluconate Solution Market

The market for CHG solution is forecast to reach $196.1 million by 2026, growing at a CAGR of 3.2% during 2021-2026. The primary drivers include the rise in demand for hand sanitizers and disinfectants, particularly exacerbated by the COVID-19 pandemic. North America dominated the market in 2020 with a 39% share, followed by Asia-Pacific and Europe. The growing healthcare industries in countries like China and India are expected to drive future market growth[2].

Isopropyl Alcohol Market

The isopropyl alcohol market is projected to reach $4.87 billion by 2025, growing at a CAGR of 4.02% during 2020-2025. The demand is driven by its use in consumer products, pharmaceuticals, and household cleaning products. The Asia-Pacific region dominates the market due to increasing demand for personal care and cosmetics, as well as growing chemical industries[3].

Market Segmentation

Chlorhexidine Gluconate Solution

  • Geography: North America, Asia-Pacific, Europe, South America, and the Rest of the World.
  • Applications: Surgical hand scrub, wound care, hand washes, preoperative body shower, general disinfectant, oral hygiene, and others[2].

Isopropyl Alcohol

  • Geography: Asia-Pacific, North America, Europe, and others.
  • End-user Industries: Chemicals, pharmaceuticals, household cleaning products, and personal care.
  • Applications: Solvents, intermediate products, disinfectants, and detergents[3].

Impact of COVID-19

The COVID-19 pandemic has significantly increased the demand for antiseptic and disinfectant solutions, including CHG and IPA. The need for effective hand sanitizers and skin disinfectants has become a daily necessity, driving market growth. However, the pandemic has also disrupted supply chains, temporarily affecting industrial activities and market dynamics[2].

Key Applications

Chlorhexidine Gluconate

  • Surgical Hand Scrub: CHG is widely used in surgical settings for preoperative hand scrubbing due to its long-lasting antibacterial properties.
  • Wound Care: CHG solutions are used to prevent infection in wound care.
  • Hand Washes: CHG is incorporated into hand washes for its sustained antimicrobial activity[2].

Isopropyl Alcohol

  • Disinfectants: IPA is used in combination with other compounds for disinfecting surfaces and clinical instruments.
  • Hand Sanitizers: IPA is a common ingredient in hand sanitizers due to its rapid action against microorganisms.
  • Intermediate Products: IPA is used in the manufacture of various industrial and household chemicals[3].

Future Projections

Chlorhexidine Gluconate Solution

The market is expected to continue growing, driven by the increasing demand for effective antiseptic solutions. The Asia-Pacific region, particularly countries like China and India, will play a significant role in future market growth due to their expanding healthcare industries[2].

Isopropyl Alcohol

The isopropyl alcohol market will continue to expand, driven by new investments in the chemical industry, especially in the Asia-Pacific region. The growing demand for consumer products and pharmaceuticals will also contribute to market growth[3].

Conclusion

Chlorhexidine gluconate and isopropyl alcohol are crucial components in the fight against bacterial infections, particularly in medical settings. Clinical trials have validated their efficacy, and market analysis indicates a strong growth trajectory driven by increasing demand and expanding healthcare industries.

Key Takeaways

  • Clinical Efficacy: CHG combined with IPA is highly effective in reducing bacterial colonization and contamination.
  • Market Growth: The CHG solution market is forecast to reach $196.1 million by 2026, while the IPA market is projected to reach $4.87 billion by 2025.
  • Applications: Both compounds are used in various medical and household applications, including surgical hand scrub, wound care, hand sanitizers, and disinfectants.
  • COVID-19 Impact: The pandemic has increased demand but also disrupted supply chains.
  • Future Projections: The Asia-Pacific region will drive future market growth for both compounds.

FAQs

What is the primary mechanism of action of chlorhexidine gluconate?

Chlorhexidine gluconate works by damaging the bacterial cell membrane, leading to the death of the bacteria.

How effective is the combination of chlorhexidine gluconate and isopropyl alcohol in skin disinfection?

The combination of 2% CHG and 70% IPA is highly effective in reducing bacterial colonization and contamination, as shown in clinical trials.

What are the main drivers of the chlorhexidine gluconate solution market?

The main drivers include the rise in demand for hand sanitizers and disinfectants, particularly due to the COVID-19 pandemic.

In which regions is the isopropyl alcohol market expected to grow significantly?

The Asia-Pacific region is expected to drive significant growth in the isopropyl alcohol market due to increasing demand for consumer products and expanding chemical industries.

What alternative methods are used for skin disinfection in individuals sensitive to chlorhexidine?

A two-step method using 10% povidone-iodine followed by 70% IPA is an effective alternative for individuals sensitive to chlorhexidine.

Sources

  1. PubMed: Efficacy of adding 2% (w/v) chlorhexidine gluconate to 70 ... - PubMed
  2. IndustryARC: Chlorhexidine Gluconate Solution Market Overview - IndustryARC
  3. IndustryARC: Isopropyl Alcohol Market - Forecast(2017-2025) Research Report
  4. 3M: Summary of Clinical Studies for Professional Healthcare Use ... - 3M
  5. Canadian Blood Services: Alternative methods of blood donor skin disinfection

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