CLINICAL TRIALS PROFILE FOR STERILE WATER FOR IRRIGATION

505(b)(2) Clinical Trials for Sterile Water For Irrigation

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
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Medstar Health Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Patient-Centered Outcomes Research Institute	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	Penn State College of Medicine	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of California, Los Angeles	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Washington	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.
OTC	NCT06076304 ↗	Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis	Active, not recruiting	University of Wisconsin, Madison	Phase 4	2023-11-21	Sinus infections are sometimes treated with antibiotics or nasal sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

All Clinical Trials for Sterile Water For Irrigation

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Boston Medical Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Icahn School of Medicine at Mount Sinai	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Schneider Children's Medical Center, Israel	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Illinois at Chicago	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	University of Tennessee Health Science Center	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.
NCT00004412 ↗	Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Completed	Susan P. Perrine	Phase 2	1997-09-01	OBJECTIVES: I. Compare the efficacy of local care alone vs local care plus arginine butyrate in terms of healing rate in patients with refractory sickle cell ulcers. II. Determine the effect of arginine butyrate therapy on tissue factors related to promotion or inhibition of wound healing in these patients. III. Determine whether the regimen used in this study is appropriate for testing in pivotal trials.

Clinical Trial Conditions for Sterile Water For Irrigation

Condition Name

Condition Name for Sterile Water For Irrigation
Intervention	Trials
Surgical Site Infection	13
Sinusitis	11
Postoperative Pain	10
Apical Periodontitis	9

Condition MeSH

Condition MeSH for Sterile Water For Irrigation
Intervention	Trials
Infections	37
Pain, Postoperative	34
Sinusitis	31
Infection	27

Clinical Trial Locations for Sterile Water For Irrigation

Trials by Country

Trials by Country for Sterile Water For Irrigation
Location	Trials
United States	205
Egypt	40
Canada	22
Pakistan	15
China	13

Trials by US State

Trials by US State for Sterile Water For Irrigation
Location	Trials
Texas	21
California	19
Pennsylvania	15
Missouri	14
New York	10

Clinical Trial Progress for Sterile Water For Irrigation

Clinical Trial Phase

Clinical Trial Phase for Sterile Water For Irrigation
Clinical Trial Phase	Trials
PHASE4	15
PHASE3	6
PHASE2	14

Clinical Trial Status

Clinical Trial Status for Sterile Water For Irrigation
Clinical Trial Phase	Trials
Completed	145
RECRUITING	72
Unknown status	48

Clinical Trial Sponsors for Sterile Water For Irrigation

Sponsor Name

Sponsor Name for Sterile Water For Irrigation
Sponsor	Trials
Cairo University	24
Washington University School of Medicine	9
Ain Shams University	8

Sponsor Type

Sponsor Type for Sterile Water For Irrigation
Sponsor	Trials
Other	483
Industry	40
U.S. Fed	6

Clinical Trials Update, Market Analysis, and Projection for Sterile Water for Irrigation

Last updated: October 28, 2025

Introduction

Sterile Water for Irrigation (SWI) is a sterile, non-pyrogenic water used in medical settings for rinsing, irrigation, and medical device cleaning. Although not classified as a pharmaceutical drug, its significance in healthcare, particularly in surgical procedures and hospital environments, necessitates rigorous regulatory oversight and continuous market assessment. This report synthesizes recent clinical trial activities, provides a comprehensive market analysis, and offers future projections, serving as a strategic resource for industry stakeholders.

Clinical Trials Landscape of Sterile Water for Irrigation

Regulatory Context and Ongoing Trials

While SWI is traditionally produced under strict sterilization processes compliant with USP and EP standards, recent years have seen targeted clinical evaluations to optimize its usage, quality, and safety.

There have been limited dedicated clinical trials specifically focusing on SWI, primarily because it functions as a medical device adjunct rather than a pharmaceutic agent. However, the following points illustrate the ongoing research trajectory:

• Safety and Efficacy Studies: Multiple hospital-based observational studies evaluate the impact of SWI use on postoperative infection rates and wound healing. These studies assess whether contamination or improper sterilization compromises patient safety.

• Sterilization Method Optimization: Trials comparing various sterilization techniques—autoclaving versus sterile filtration—aim to establish best practices for maintaining sterility without compromising water integrity.

• Product Quality and Standards Validation: Recent clinical evaluations validate the compliance of SWI with Pharmacopoeia standards, ensuring consistent quality across manufacturing lots.

Innovations and R&D Focus

Emerging research emphasizes integrating SWI with adjunctive agents, such as antiseptic solutions, in controlled clinical settings. These innovations aim to expand the application scope, especially in selective surgeries requiring specific irrigating solutions.

Additionally, regulatory bodies like the FDA and EMA are increasingly emphasizing sterilization validation and shelf stability, guiding manufacturers toward more optimized production processes.

Regulatory Developments Impacting Clinical Use

The US FDA has issued clear guidelines on the sterilization processes and labeling requirements for SWI, reinforcing safety standards. Recent updates emphasize batch validation and traceability, impacting clinical protocols and manufacturing practices.

In Europe, the European Pharmacopoeia's monographs on sterile water establish standardized quality benchmarks, influencing clinical practice guidelines globally.

Market Analysis of Sterile Water for Irrigation

Market Size and Segmentation

The global Sterile Water for Irrigation market is driven primarily by the healthcare sector’s continuous demand for sterile fluids in operating rooms, laboratories, and outpatient clinics.

• Market Valuation (2023): Estimated at approximately $250 million globally, with North America representing around 40% of the market share due to high healthcare infrastructure standards and surgical procedures volume.

• Regional Breakdown:

  • North America: Dominant market, supported by strict regulatory standards and high surgical volume.
  • Europe: Significant growth, bolstered by regulatory harmonization and expanding hospital infrastructure.
  • Asia-Pacific: Fastest-growing segment, driven by rising healthcare expenditure, improved sterilization standards, and increasing surgical procedures.

Driving Factors

• Rising surgical procedures: An increasing prevalence of surgeries (cardiac, orthopedic, gynecological) enhances demand.
• Hospital procurement policies: Hospitals prefer pre-sterilized, single-use SWI products to minimize infection risk.
• Regulatory standardization: Increasing compliance with pharmaceutical-grade standards ensures consistent demand.
• Infection control emphasis: Heightened focus on sterile environments drives procurement of high-quality irrigating solutions.

Competitive Landscape

Major suppliers include Baxter International, B. Braun, Fresenius Medical Care, and local pharmaceutical and medical device companies. Market consolidation has led to increased standardization and supply chain efficiencies.

Challenges

• Supply Chain Disruptions: Global manufacturing and distribution challenges impact product availability.
• Regulatory Hurdles: Stringent compliance requirements increase costs and complexity.
• Environmental Concerns: Packaging waste and single-use product mandates are prompting industry innovation for sustainable solutions.

Regulatory and Quality Standards Impact

Adherence to ISO 13485, USP, and EP standards influences product acceptance and market penetration. Certification requirements act as barriers for new entrants but also uphold quality benchmarks.

Market Projection and Future Trends

Market Growth Outlook (2024–2030)

The Sterile Water for Irrigation market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6% over the next seven years, reaching an estimated valuation of $400 million by 2030.

Key Drivers for Growth

• Expanding Surgical Volume: Global increase in elective surgeries, minimally invasive techniques, and aging populations sustains demand.
• Emerging Markets: Rapid healthcare development in Asia-Pacific and Latin America offers significant growth opportunities.
• Innovation in Product Delivery: Development of pre-filled, single-use sterile containers enhances convenience and safety, opening new market segments.
• Regulatory Demand for Quality and Safety: Incremental tightening of standards ensures high-quality SWI products, fostering brand loyalty and market stabilization.

Potential Disruptors and Opportunities

• Sustainable Packaging: Eco-friendly, biodegradable containers may redefine procurement preferences.
• Integration with Monitoring Technologies: Smart irrigation systems that track sterility and usability could expand SWI applications.
• Alternative Solutions: The advent of sterile saline and specialized irrigating solutions may challenge SWI dominance in certain scenarios.

Regional Growth Strategies

• North America and Europe: Focused on compliance, quality enhancement, and supply chain robustness.
• Asia-Pacific: Opportunities driven by rising healthcare investment, local manufacturing, and government initiatives for healthcare infrastructure.

Conclusion

While clinical trials specific to Sterile Water for Irrigation remain limited, ongoing research emphasizes safety, sterilization efficacy, and standards validation, underpinning its critical role in medical procedures. The market demonstrates consistent growth prospects, buoyed by increasing surgical demands, regulatory emphasis on infection control, and technological innovation. Stakeholders investing in manufacturing, quality assurance, and supply chain resilience will be well-positioned to capitalize on emerging opportunities.

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Key Takeaways

• Clinical trials predominantly validate sterilization methods, safety, and product standards rather than therapeutic efficacy since SWI functions as an adjunct, not an active pharmaceutical.
• The global SWI market is expected to grow at a CAGR of approximately 6%, reaching $400 million by 2030, driven by expanding surgical procedures and healthcare infrastructure.
• North America leads the market due to regulatory rigor and high surgical volumes, while Asia-Pacific presents significant growth opportunities.
• Technological innovations, such as pre-filled sterile containers and integration with monitoring systems, present new avenues for market expansion.
• Ensuring regulatory compliance and fostering supply chain resilience are critical for sustained market growth and competitiveness.

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FAQs

1. What are the primary clinical concerns associated with Sterile Water for Irrigation?
Clinical concerns include contamination risk during sterilization, ensuring consistent sterility, and preventing infection transmission in surgical and procedural settings. Regular validation and adherence to standards mitigate these risks.

2. How does regulatory oversight influence the market for SWI?
Regulatory agencies like the FDA and EMA enforce rigorous standards for sterilization, quality control, and labeling. Compliance ensures product safety, influencing manufacturing practices and market access.

3. What are the main industry innovations impacting SWI?
Innovations include single-use pre-filled containers, eco-friendly packaging, and integration with smart monitoring systems, improving safety, convenience, and environmental sustainability.

4. Which regions are expected to dominate future SWI market growth?
North America and Europe currently dominate, but Asia-Pacific is projected to witness the fastest growth due to expanding healthcare infrastructure and rising surgical procedures.

5. What are potential challenges facing SWI manufacturers?
Manufacturers face regulatory hurdles, supply chain disruptions, environmental concerns regarding packaging waste, and competition from alternative irrigating solutions.

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Sources:

1. [1] MarketsandMarkets, "Sterile Water Market by Product," 2022.
2. [2] U.S. Food and Drug Administration (FDA), Guidance Documents, 2023.
3. [3] European Pharmacopoeia, Monograph on Water for Injections, 2022.
4. [4] Global Industry Analysts, "Medical Supplies and Devices Market," 2023.
5. [5] Industry reports and peer-reviewed studies on sterilization and infection control standards.