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Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease

RecruitingNAAges 18 Years - anyAllYosef Nasseri, MD
NCT07321704 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Pilonidal disease is a chronic condition that causes painful inflammation and infection near the top of the buttocks. Many patients require surgery, and one commonly used approach is a bilateral gluteal fasciocutaneous flap with midline closure along with placement of an extracellular matrix to support wound healing. Although effective, this surgery can still lead to wound problems such as infection, fluid collection (seroma), wound separation (dehiscence), and delayed healing. This study aims to compare two different solutions used to rinse the surgical wound before closing it. One solution is Irrisept, which contains 0.05% chlorhexidine gluconate, an antiseptic designed to reduce bacteria. The other is normal saline, which is the current standard rinse used in surgery. The goal is to determine whether using Irrisept can safely reduce post-operative infections and wound-related complic

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan 2. Male or female patients aged 18 years or above 3. Patients scheduled for flap-based procedure for pilonidal disease with planned use of Irrisept or normal saline irrigation 4. Subjects who are willing and able to comply with all aspects of the treatment and evaluation schedule Exclusion Criteria: 1. Known allergy to contents of Irrisept (chlorhexidine gluconate) 2. Full-thickness ('third degree') burns 3. Wounds with uncontrolled clinical infection (CDC Contamination Grade 4) 4. Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study 5. Currently participating or has participated in another clinical study within 30 days prior to enrollment 6. Pregnant or lactating women 7. Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
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What it tests

  • Irrisept (0.05% chlorhexidine gluconate)
  • Normal Saline
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Where

1 site
Surgery Group LA
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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