Chlorhexidine (Irrisept) versus normal saline rinse for flap closure in pilonidal disease
Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease With Myriad Extracellular Matrix Implantation
This will see if rinsing the surgical wound with Irrisept (0.05% chlorhexidine) instead of normal saline reduces infections and other wound problems in adults having fasciocutaneous flap surgery for pilonidal disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nasseri,Yosef MD Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07321704 on ClinicalTrials.gov |
What this trial studies
Adults undergoing bilateral gluteal fasciocutaneous flap closure with implantation of an extracellular matrix for pilonidal disease will receive wound irrigation with either Irrisept (0.05% chlorhexidine gluconate) or standard normal saline prior to surgical closure. The study prospectively compares post-operative outcomes including infection, seroma, hematoma, wound dehiscence, and time to complete wound healing between the two irrigation groups. Participants will be treated at a single clinical site and followed after surgery for healing progress and any adverse events. Standard perioperative care aside from the assigned irrigation solution will be followed.
Who should consider this trial
Good fit: Adults aged 18 and older who are scheduled for bilateral gluteal fasciocutaneous flap closure with extracellular matrix implantation for pilonidal disease and who can give informed consent are ideal candidates.
Not a fit: Patients with a known allergy to chlorhexidine, uncontrolled wound infection, full-thickness burns, pregnant or lactating women, or those otherwise judged unsuitable by the investigator are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, using Irrisept could reduce post-operative infections and wound complications and speed healing after flap closure for pilonidal disease.
How similar studies have performed: Antiseptic irrigation with chlorhexidine has reduced surgical site infections in some other surgical settings, but its specific benefit for pilonidal flap closure is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- Surgery Group LA — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Yosef Nasseri, MD
- Email: yosefn@surgerygroupofla.com
- Phone: 310-289-1518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.