This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.

Start Date01 Apr 2025

Sponsor / Collaborator

Loma Linda University

[+1]

NCT06689176

/ RecruitingNot ApplicableIIT

Chlorhexidine Antiseptic Irrigation of the Bowel Segment During Radical Cystectomy and Urinary Diversion After Chlorhexidine Irrigation in Patients Undergoing Radical Cystectomy

This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.

Start Date01 Aug 2024

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

NCT06163469

/ RecruitingNot ApplicableIIT

Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters

The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are:
is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients.
does this protocol decrease the rate of unplanned health care visits and improve patient quality of life.
Patients will undergo the treatment protocol during their routine suprapubic catheter exchanges.

Start Date01 Apr 2024

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Irrimax Corp.

0 Patents (Medical) associated with Irrimax Corp.

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03 Jan 2025·The Journal of Sexual Medicine

Letter to Editor on “Antibiotic dip and irrigation solutions confer increased antimicrobial efficacy of inflatable penile prosthesis hydrophilic surfaces compared with 0.05% chlorhexidine gluconate”

Article

Author: Griggs, Ryan ; Karpman, Edward ; Twomey, Carolyn ; Henry, Gerard D

12 Aug 2024·The Journal of Sexual Medicine

(141) COMPARATIVE STUDY DIPPING TITAN IMPLANTS IN IRRISEPT (0.05% CHG) SOLUTION, VANCOMYCIN/GENTAMICIN OR SALINE CONTROL AND EXPOSURE TO VARIOUS MICROBIAL SPECIES

Author: Twomey, C ; Griggs, R ; Henry, GD ; Karpman, E

AbstractIntroductionInfection retardant coated implants have significantly decreased penile prosthesis infection (PPI) since their release in 2001. However, the microbial spectrum of PPI has significantly changed since then based on recent literature reports of PPI. Gram negative and fungal species are now included in the three most common organisms isolated during PPI. Irrisept® is a 0.05% chlorhexidine gluconate (CHG) antiseptic solution that has been shown to be effective at treating the most common aerobic, anaerobic and fungal species causing PPI in a recent publication. The study simulated the real world practice of dipping and irrigating penile implants with an antimicrobial solution. However, the study was compared to saline control only. Here we present the results from the largest comparative study of Irrisept® solution, Vancomycin/Gentamicin (V/G) and a saline control on microbial reduction in hydrophilic coated implants.ObjectiveEvaluate the microbial reduction by Irrisept®, V/G and saline dipped and irrigated Titan® implant discs.MethodsThe previously published protocol was used adding a V/G arm. (Figure 1 and 2) An in-vitro microbial reduction evaluation of the ability of an irrigation solution and device or V/G to remove transient bacterial contamination from a test substrate - pre-cut discs prepared from a penile implant material. Three microorganisms - Escherichia coli (A TCC #25922), Pseudomonas aeruginosa (ATCC #27853), and Staphylococcus aureus (ATCC #25923) were used for this evaluation. For each challenge species, three discs of the implant material (i.e., Baseline Carriers) were pre-conditioned by immersion in 0.9% Sodium Chloride Irrigation, USP (Baseline Controls), three discs were pre-conditioned by immersion in the irrigation solution (Irrisept®) and three discs in V/G; (i.e., Test Carriers). The pre-conditioned carriers were allowed to dry for approximately 10 minutes prior to contamination with a suspension of each test strain. Following a 2-to-3-minute drying period at room temperature, the three contaminated Baseline Carriers were evaluated for viable microbial recoveries, three of the contaminated and dried Test Carriers were evaluated for viable microbial recoveries with no additional treatment (Pre- Rinse Test Carriers), and the three remaining Test Carriers were evaluated following a rinsing procedure using the wound irrigation device/solution, V/G or saline (Post-Rinse Test Carriers).ResultsTable 1 presents the Initial Populations (CFU/mL), the Mean Baseline Control Recoveries (log10), the Mean Pre-Exposure Reduction (log10) and the mean Post-Exposure Recovery (log10) of Escherichia coli (ATCC #25922), Pseudomonas aeruginosa (ATCC #27853), and Staphylococcus aureus (ATCC #25923) produced by the wound irrigation device/solution (lrrisept® 450 mL [Lot #21HDB982]), V/G or saline following three rinses/irrigations. Irrisept® was more effective than V/G and saline in reducing microbial counts in all the organisms tested.ConclusionsIrrisept® dipped and irrigated Titan® discs are shown to kill all the tested bacteria better than V/G or saline. The log reduction in bacterial species is consistent with the known efficacy of V/G and Irrisept® in other studies. Further comparative clinical studies are needed to evaluate the best solution for dipping and irrigating hydrophilic coated penile implants.DisclosureYes, this is sponsored by industry/sponsor: Coloplast and Irrimax.Clarification: Industry funding only - investigator initiated and executed study.Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Irrimax.

28 Jun 2023·The Journal of Sexual Medicine

Dipping Titan implants in Irrisept solution (0.05% chlorhexidine gluconate) and exposure to various aerobic, anaerobic, and fungal species

Article

Author: Griggs, Ryan ; Karpman, Edward ; Twomey, Carolyn ; Henry, Gerard D

AbstractBackgroundThe organisms causing penile implant infections are changing from predominantly indolent gram-positive infections to more aggressive gram-negative and fungal infections because of antibiotic selection pressures based on novel next-generation sequencing DNA data.AimTo evaluate the effectiveness of Irrisept solution (0.05% chlorhexidine gluconate) in decreasing isolate colony counts from a Titan implant by using a novel kill time washout methodology to mirror real-world usage.MethodsSterilized Titan discs were dipped in Irrisept or saline. An inoculum of 109 organisms of a single bacterial or fungal species was placed on the discs. Bacterial and fungal strains were tested: Bacteroides fragilis, Candida albicans, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Staphylococcus epidermidis. The discs were then irrigated 3 times with Irrisept or saline. Microorganisms were sonicated off the discs and placed on appropriate agar and conditions for each species. The plates were incubated for 48 to 72 hours at the temperature and under the conditions appropriate for each species. Colonies on the plates were hand counted.OutcomesIrrisept effectively decreased microbial colony counts in all the species tested.ResultsIrrisept was shown to effectively decrease microbial colony counts from 3 to 6 log10 in all species tested. A 3-log10 reduction is considered the target level of performance that would indicate that a compound or product has effective killing activity against an organism of interest. The saline control with bulb syringe irrigation did not demonstrate reduction of microbial colony counts in any of the species tested.Clinical ImplicationsIrrisept is effective against all of the organisms causing modern-day infections with penile implant surgery and may decrease clinical infection rates to lower levels.Strengths and LimitationsThe strength of this study is that we used quantitative microbial reduction counting and the largest array of bacterial and fungal species causing modern-day penile implant infections. The limitation is that this is an in vitro study and the clinical implications of our findings are not yet known.ConclusionQuantitative microbial reduction counting shows that Irrisept is effective against the most commonly known modern-day organisms causing penile implant infections.

News (Medical) associated with Irrimax Corp.

29 Aug 2024

·www.prnewswire.com

Irrimax Launches New IRRISEPT® Kits-Continues to Provide Irrigation Innovation

Completes Phase II of Promised Innovation Pipeline LAWRENCEVILLE, Ga., Aug. 21, 2024 /PRNewswire/ -- Medical device manufacturer Irrimax Corporation, known globally for its antimicrobial wound lavage product, IRRISEPT®, delivers promised innovation and enhancements in multiple healthcare market segments. Irrimax is now introducing new products and accessories to enable the use of the proprietary Irrisept solution with powered irrigation devices, continuing to expand on the company's mission to reduce infections and healthcare costs and improve patient outcomes. Continue Reading Irrisept Wound Solution Kit Irrisept Accessory Kit "Irrimax is committed to meeting the needs of its customers, which is at the core of our customer-centric approach," shares President and Chief Operating Officer Michael Gil. "While Irrisept has become a standard of care in many hospitals globally, our customers have expressed additional needs regarding how and when they could use Irrisept, especially in minimally invasive procedures. We developed these products in response to those customer needs and insights, and we're thrilled to be able to answer that market demand with these new product innovations." Irrimax announced that it would expand its portfolio by releasing a series of enhancements and new products, instituting a two-phase innovation pipeline, and releasing five new products within a two-year window. Phase one took the flagship IRRISEPT Antimicrobial Wound Lavage product design and considered features and applications for utilization across the continuum of care in settings ranging from pre-hospital to acute and post-acute. Now Irrimax has launched the second phase, unveiling two new kits, the 'IRRISEPT Accessory Kit' and 'IRRISEPT Wound Solution Kit.' These new kits are designed to be used in conjunction with the original IRRISEPT Antimicrobial Wound Lavage product. This gives clinicians flexibility and choice in their application of IRRISEPT by choosing to use manual compression for irrigation or by attaching an adapter and spiking the bottle for utilization with powered irrigation systems such as suction irrigation, pulse lavage, negative pressure wound therapy, and other systems. Both kits are now available in the US market. Irrimax is actively working to make its added portfolio options available globally and continues to execute additional projects in its innovative product and development pipeline. About Irrimax Corporation Established in 1994, Irrimax Corporation has been steadfast in its mission to reduce infections and healthcare costs while improving patient outcomes. Its flagship product is IRRISEPT Antimicrobial Wound Lavage, containing 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, USP. For more information, visit . SOURCE Irrimax Corporation

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