Chlorhexidine for Wound Infection in Emergency 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.12345Why 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.13467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo irrigation with either Irrisept or normal saline during surgery
Follow-up
Participants are monitored for surgical site infections and other outcomes
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?
2
Treatment groups
Experimental Treatment
Placebo Group
Irrigation with Irrisept
Irrigation with Normal Saline
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at Tyler
Lead Sponsor
Irrimax Corporation
Industry Sponsor
Citations
Irrisept: Home
Irrisept antimicrobial wound lavage is a self-contained jet lavage with low concentration CHG as a preservative in the bottled solution.
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 ...
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 ...
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 ...
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 ...
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.
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 ...
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