Chlorhexidine for Wound Infection in Emergency Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center at Tyler

Disqualifiers: Under 18, Pressure wounds, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate (during surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using Irrisept, a special cleaning solution, during emergency surgeries reduces the chance of wound infections compared to regular saltwater. Researchers will compare outcomes between patients receiving Irrisept and those receiving normal saline. It targets patients at UT Tyler needing emergency open surgery due to conditions like serious infections or injuries, excluding cases such as pressure wounds or superficial abscesses. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective Irrisept can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Irrisept?

Research shows that Irrisept is safe to use. Tested for over 12 years, studies confirm its effectiveness in cleaning wounds and reducing bacteria. This extensive use and thorough study support its reliability.

Safety data from these studies indicate that people generally tolerate Irrisept well, with no major reports of serious side effects. However, it's important to follow instructions, such as avoiding use near the eyes or ears.

Overall, existing evidence suggests that Irrisept is a safe choice for cleaning wounds during surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Irrisept because it offers a unique approach to preventing wound infections in emergency surgery. Unlike the standard practice of using normal saline for irrigation, Irrisept incorporates chlorhexidine, an antiseptic known for its strong antimicrobial properties. This could potentially reduce infection rates more effectively by directly targeting and killing bacteria during the irrigation process, providing a more robust defense against infection than the typical saline rinse.

What evidence suggests that Irrisept is effective for reducing wound infections in emergency surgery?

Research has shown that using Irrisept, which contains the antiseptic chlorhexidine gluconate, can lower the risk of infections after surgery. In this trial, participants will join different treatment arms, with one group receiving Irrisept irrigation. Studies have found that using a 0.05% chlorhexidine solution during operations reduces infection rates in various surgeries, such as those for pilonidal disease. Specifically, another study demonstrated that patients who underwent surgeries with Irrisept irrigation experienced fewer infections afterward, particularly in foot and ankle reconstruction surgeries. This suggests that Irrisept's antiseptic qualities may effectively prevent infections after surgery. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized at UT Tyler and need emergency open surgery (or conversion to open) for a serious condition. It's not for those with pressure wounds, under 18, superficial abscesses as the main issue, or abscesses from past surgeries gone wrong.

Inclusion Criteria

I am over 18, hospitalized at UT Tyler, and had or will have emergency surgery that opened or will open my body.

Exclusion Criteria

I have pressure wounds.

I am under 18 years old.

My primary diagnosis is a superficial abscess.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo irrigation with either Irrisept or normal saline during surgery

Immediate (during surgery)

Follow-up

Participants are monitored for surgical site infections and other outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept

Trial Overview The study compares two ways of cleaning surgical sites: using Irrisept (with Chlorhexidine) versus normal saline solution. The goal is to see which method better prevents infections after emergency general surgery.

How Is the Trial Designed?

Group I: Intervention (Irrisept) Experimental Treatment 1 Intervention

Irrigation with Irrisept

Group II: Standard of Care (Normal Saline) Placebo Group 1 Intervention

Irrigation with Normal Saline

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at Tyler

Lead Sponsor

Trials

15

Recruited

25,700+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Citations

1. irrisept.com irrisept.com/

Irrisept: Home Irrisept antimicrobial wound lavage is a self-contained jet lavage with low concentration CHG as a preservative in the bottled solution.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2817941

Incisional Wound Irrigation for the Prevention of Surgical ... Incisional wound irrigation with aqueous antiseptic solutions was associated with a reduction in the risk of SSIs; results suggest that the use of antibiotic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07048899

Irrisept in Emergency General Surgery Patients This is a single institution, randomized study conducted to determine if irrigation with Irrisept in emergency general surgery patients results in lower ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2667396723000022

Retrospective analysis of operating room irrigation using a ... Overall, the data showed a low incidence of postoperative SSI in patients who underwent reconstructive foot and ankle surgery with intraoperative lavage ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995975/

Chlorhexidine Gluconate Irrigation in the Prevention of ... Intraoperative irrigation with 0.05% CHG has been associated with lower SSI rates in surgical practices, including pilonidal disease excision ...

6. irrisept.com irrisept.com/research/

Research Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.

7. irrisept.com irrisept.com/wp-content/uploads/2024/02/Irrisept-Brochure-772722-V4.pdf

DO YOUR BEST AGAINST THE WORST. CAUTIONS: • Do not use unless solution is clear and bottle twist seal is intact. • When using this product, keep away from the eyes and ear ...