Irrisept vs Normal Saline for Pilonidal Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two solutions for cleaning surgical wounds in individuals with pilonidal disease, a condition causing painful infection near the top of the buttocks. One group will have their wounds rinsed with Irrisept, an antiseptic that reduces bacteria, while the other group will use normal saline, the standard solution. The researchers aim to determine if Irrisept can lower the risk of infections and other wound complications after surgery. This trial suits individuals scheduled for specific surgery to treat pilonidal disease and who can adhere to the study's schedule. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance surgical outcomes for future patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that using Irrisept, which contains 0.05% chlorhexidine gluconate, can be safe and helpful in surgeries. Studies have linked this antiseptic solution to fewer surgical site infections. For instance, one study found that patients treated with chlorhexidine gluconate healed better than those using a standard solution. Specifically, 94.2% of patients using chlorhexidine gluconate experienced primary healing, compared to 80.6% in the control group. Additionally, the average healing time was shorter, about 20.5 days.
These results suggest that Irrisept may effectively reduce surgery-related complications. However, personal factors should be considered, and individuals should consult healthcare providers before joining a clinical trial. Overall, current evidence supports the safety of Irrisept for cleaning surgical wounds.12345Why are researchers excited about this trial?
Researchers are excited about Irrisept because it offers a novel approach to treating pilonidal disease. Unlike the standard practice of using normal saline for wound irrigation, Irrisept contains 0.05% chlorhexidine gluconate, an antiseptic known for its ability to reduce bacterial load. This could potentially lead to better infection control and improved healing outcomes. By targeting bacteria directly at the surgical site, Irrisept aims to enhance recovery and minimize complications, making it a promising alternative to traditional saline irrigation methods.
What evidence suggests that this trial's treatments could be effective for pilonidal disease?
This trial will compare the use of Irrisept, containing 0.05% chlorhexidine gluconate, with normal saline for wound irrigation in pilonidal disease surgeries. Research has shown that using Irrisept for wound cleaning can lower the risk of infections after such surgeries. Studies have found that this antiseptic solution not only reduces infection rates but also speeds up wound healing post-surgery. Chlorhexidine gluconate kills bacteria, preventing complications after surgery. By reducing these complications, Irrisept may enhance recovery for patients undergoing surgery for pilonidal disease.13678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with pilonidal disease who are about to have flap-based surgery. Participants must be willing to follow the study plan and use either Irrisept or normal saline as directed during their procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix and receive intraoperative wound irrigation using either Irrisept or normal saline
Follow-up
Participants are monitored for safety and effectiveness, including postoperative infection, wound dehiscence, and time to complete wound healing
What Are the Treatments Tested in This Trial?
Interventions
- Irrisept
Trial Overview
The study compares two solutions used in surgical wound cleaning before closure: Irrisept, which contains an antiseptic called chlorhexidine gluconate, and normal saline, the standard rinse. The aim is to see if Irrisept better prevents post-surgery infections and other wound complications.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants undergoing bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix will receive intraoperative wound irrigation using Irrisept (0.05% chlorhexidine gluconate) according to the surgeon's standard technique. Irrigation is applied immediately before surgical closure.
Participants undergoing bilateral gluteal fasciocutaneous flap closure with implantation of Myriad extracellular matrix will receive intraoperative wound irrigation using sterile normal saline, consistent with current standard surgical practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yosef Nasseri, MD
Lead Sponsor
Irrimax Corporation
Industry Sponsor
Citations
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine ...
This prospective study evaluates whether the use of Irrisept (0.05% chlorhexidine gluconate) as an antimicrobial irrigation solution during flap ...
Wound Irrigation with Chlorhexidine Gluconate Reduces ...
Intra-operative incision irrigation with CHG decreased the SSI rate and time to healing in pilonidal disease surgery.
Wound Irrigation with Chlorhexidine Gluconate Reduces ...
Background: The aim of this study was to determine whether incision irrigation with chlorhexidine gluconate (CHG) reduces surgical site infections (SSIs) in ...
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journals.sagepub.com
journals.sagepub.com/doi/10.1089/sur.2019.053?icid=int.sj-full-text.similar-articles.8Wound Irrigation with Chlorhexidine Gluconate Reduces ...
Conclusion: Intra-operative incision irrigation with CHG decreased the SSI rate and time to healing in pilonidal disease surgery. Further randomized trials ...
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 ...
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 ...
Wound Irrigation with Chlorhexidine Gluconate Reduces ...
Conclusion: Intra-operative incision irrigation with CHG decreased the SSI rate and time to healing in pilonidal disease surgery. Further ...
Irrisept vs Normal Saline for Pilonidal Disease
The study compares two solutions used in surgical wound cleaning before closure: Irrisept, which contains an antiseptic called chlorhexidine ...
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