CLINICAL TRIALS PROFILE FOR BETADINE

All Clinical Trials for BETADINE

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 BETADINE

Condition Name

Condition Name for BETADINE
Intervention	Trials
Surgical Site Infection	11
Wound Infection	3
Surgical Wound Infection	2
Chronic Rhinosinusitis (Diagnosis)	2

Condition MeSH

Condition MeSH for BETADINE
Intervention	Trials
Infections	15
Surgical Wound Infection	14
Communicable Diseases	13
Infection	11

Clinical Trial Locations for BETADINE

Trials by Country

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Trials by Country for BETADINE
Location	Trials
United States	40
Egypt	12
Canada	3
Singapore	2
Netherlands	2

Trials by US State

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−

Trials by US State for BETADINE
Location	Trials
Pennsylvania	5
Florida	5
Texas	4
Massachusetts	4
Missouri	3

Clinical Trial Progress for BETADINE

Clinical Trial Phase

Clinical Trial Phase for BETADINE
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for BETADINE
Clinical Trial Phase	Trials
Completed	28
Recruiting	13
Unknown status	8

Clinical Trial Sponsors for BETADINE

Sponsor Name

Sponsor Name for BETADINE
Sponsor	Trials
Cairo University	7
Assiut University	3
University of Miami	3

Sponsor Type

Sponsor Type for BETADINE
Sponsor	Trials
Other	92
U.S. Fed	6
Industry	4

Betadine (Povidone-Iodine): Clinical Trials, Market Analysis, and Projections

Introduction to Betadine (Povidone-Iodine)

Betadine, also known as povidone-iodine (PVP-I), is a widely used antiseptic and disinfectant. It is employed in various medical and non-medical applications due to its broad-spectrum antimicrobial properties.

Clinical Trials Update

Reducing CAUTIs

A significant clinical trial focused on the use of Betadine to reduce Catheter-Associated Urinary Tract Infections (CAUTIs). This randomized trial, conducted at Beaumont Hospital, involved 110 male patients who were randomized to either receive standard care (catheter removal without any intervention) or a bladder irrigation with 2% povidone-iodine solution before catheter removal. The primary endpoint was the presence or absence of CAUTIs 48-72 hours after catheter removal, assessed through urinalysis, urine culture, and a UTI Symptom Assessment questionnaire. The trial aimed to evaluate the effectiveness of Betadine in reducing bacteriuria and CAUTIs without increasing antimicrobial resistance[1].

Preventing Dental Caries

Another clinical trial, a Phase II randomized, double-blind, placebo-controlled study, is evaluating the efficacy of 10% povidone-iodine in preventing new cavitated caries lesions in children with Severe Early Childhood Caries (S-ECC). The study involves applying 10% PVPI along with fluoride varnish and comparing it to a placebo plus fluoride varnish. Participants will be followed for approximately 24 months post-baseline, with interventions administered at regular intervals[4].

COVID-19 and Virucidal Properties

During the COVID-19 pandemic, there has been increased interest in the virucidal properties of povidone-iodine. Companies like Avrio Health have initiated programs to evaluate the safety and efficacy of Betadine antiseptic products against the novel coronavirus. These studies involve in vitro and in vivo investigations to examine the effectiveness of povidone-iodine against COVID-19[3].

Market Analysis

Market Size and Growth

The global povidone-iodine market is projected to experience significant growth over the next several years. According to market research, the global povidone-iodine market was valued at USD 167.41 million in 2024 and is expected to reach USD 242.66 million by 2032, growing at a CAGR of 4.75% during the forecast period of 2025 to 2032[2].

Another report estimates the market size to be USD 145.06 million in 2024, projected to reach USD 204.57 million by 2031, with a CAGR of 4.39% from 2024 to 2031[5].

Market Segmentation

The povidone-iodine market is segmented by product type (electronic grade, pharmaceutical grade, industrial grade, medical grade), type (scrub, topical solution, ointments), concentration (10% solution, 7.5% solution), application (infection prevention, skin sterilization, instrument sterilization, aquaculture, breeding industry, food industry, hospitals and clinics), and end-users (agrochemicals, electronics, paints and coatings, petrochemicals, pharmaceuticals)[2].

Key Drivers

The market growth is driven by several factors, including:

• Increasing Incidences of Infections: The need for efficient disinfectants, especially in healthcare settings, has been amplified by the COVID-19 pandemic.
• Rising Awareness of Infection Control: Growing emphasis on preventive healthcare measures and the use of antiseptics in home care and personal hygiene products.
• Chronic Wounds: The rising prevalence of chronic wounds, particularly in diabetic patients, drives demand for wound care treatments like povidone-iodine-based solutions[5].

Regional Analysis

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South America. North America, particularly the United States, is expected to exhibit substantial growth due to the high incidence of chronic wounds and the increasing need for wound care treatments[5].

Latest Developments

Product Launches

Recent developments include the launch of new products such as BD Purprep, a fully sterile povidone-iodine solution for skin preparation, and Avrio Health's Betadine antiseptic oral rinse for professional use in dental procedures. These launches aim to expand product portfolios and create competitive advantages in the market[2][3].

Research and Development

Significant investments in research and development are enhancing product applications. For instance, studies on the use of povidone-iodine liposome hydrogel for topical wound treatment and its virucidal properties against COVID-19 are ongoing. These efforts are expected to further expand the market's growth potential[2][3].

Challenges and Restraints

Side Effects and Alternatives

Despite its benefits, povidone-iodine has some side effects, such as local irritation, itching, and rash, which can be corrosive if used excessively. The availability of alternative disinfectants also poses a challenge to the market growth[2].

Key Takeaways

• Clinical Trials: Ongoing trials are evaluating the efficacy of Betadine in reducing CAUTIs and preventing dental caries, as well as its virucidal properties against COVID-19.
• Market Growth: The global povidone-iodine market is projected to grow at a CAGR of 4.75% to 4.39% from 2024 to 2032, driven by increasing awareness of infection control and the need for efficient disinfectants.
• Market Segmentation: The market is segmented by product type, application, and end-users, with significant growth expected in the healthcare and wound care sectors.
• Regional Analysis: North America is expected to exhibit substantial growth due to the high incidence of chronic wounds and the increasing need for wound care treatments.

FAQs

What is the primary use of Betadine in clinical settings?

Betadine, or povidone-iodine, is primarily used as an antiseptic and disinfectant in clinical settings to prevent infections and reduce the risk of bacteriuria and CAUTIs.

What are the potential side effects of using Betadine?

Potential side effects include local irritation, itching, rash, and in rare cases, allergic reactions or brown discoloration of urine.

How is the global povidone-iodine market expected to grow?

The global povidone-iodine market is expected to grow at a CAGR of 4.75% to 4.39% from 2024 to 2032, reaching a valuation of USD 242.66 million to USD 204.57 million by 2032.

What are the key drivers of the povidone-iodine market?

Key drivers include the increasing awareness of infection control, the need for efficient disinfectants, and the growing prevalence of chronic wounds.

Are there any ongoing clinical trials evaluating the efficacy of Betadine?

Yes, there are ongoing clinical trials evaluating the efficacy of Betadine in reducing CAUTIs, preventing dental caries, and its virucidal properties against COVID-19.

What are some of the latest developments in the povidone-iodine market?

Recent developments include the launch of new products like BD Purprep and Avrio Health's Betadine antiseptic oral rinse, as well as significant investments in research and development to enhance product applications.

Sources

1. A Randomized Trial of Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal to Reduce Bacteriuria and Catheter-Associated Urinary Tract Infections. ClinicalTrials.gov.
2. Global Povidone Iodine Market Size, Share, and Trends Analysis. Data Bridge Market Research.
3. Povidone Iodine Market | Global Industry Report, 2030. Transparency Market Research.
4. Povidone Iodine Efficacy Study | Clinical Research Trial Listing. CenterWatch.
5. Povidone Iodine Market Size, Share, Trends, Scope & Forecast. Verified Market Research.