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 complications in patients undergoing flap closure and extracellular matrix implantation for pilonidal disease.
Willing and able to provide written informed consent and to comply with the requirements of the Clinical Investigational Plan
Male or female patients aged 18 years or above
Patients scheduled for flap-based procedure for pilonidal disease with planned use of Irrisept or normal saline irrigation
Subjects who are willing and able to comply with all aspects of the treatment and evaluation schedule
Known allergy to contents of Irrisept (chlorhexidine gluconate)
Full-thickness ('third degree') burns
Wounds with uncontrolled clinical infection (CDC Contamination Grade 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
Parallel
Irrisept (0.05% chlorhexidine gluconate)
DeviceIrrisept solution will be used to irrigate the surgical wound prior to flap closure. The solution is applied using manufacturer-recommended technique and volume. No other changes to surgical care are made.
Normal Saline
Other interventionSterile normal saline will be used to irrigate the surgical wound prior to flap closure according to the surgeon's standard technique. No antiseptic agents will be added.
Treatment-Emergent Adverse Events (TEAEs)
Proportion of participants who experience any treatment-emergent adverse event following surgery and throughout the follow-up period. Adverse events include any unfavorable or unintended sign, symptom, or medical occurrence temporally associated with the study intervention.
Time to Complete Wound Healing
Number of weeks from surgery to complete wound healing, defined as full epithelialization without drainage, dehiscence, or need for additional wound treatment.
Postoperative Infection Rate
Proportion of participants who develop a postoperative surgical site infection, defined by clinical assessment as purulent drainage, positive wound culture, or physician diagnosis requiring antibiotics or procedural intervention.
Seroma or Hematoma Formation
Proportion of participants who develop a postoperative seroma or hematoma confirmed by clinical exam or imaging and requiring observation or intervention.
Wound Dehiscence
Proportion of participants who experience wound separation (partial or complete) requiring additional wound care, packing, or procedural management.
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