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.
Pilonidal sinus disease (PSD) is an acquired condition involving chronic inflammation and infection in the sacrococcygeal region. Over time, PSD can lead to recurrent infections, draining tracts, abscess formation, and the need for repeated procedures. Surgical management often includes flap-based closure techniques. The bilateral gluteal fasciocutaneous flap with midline closure, combined with implantation of an extracellular matrix, is designed to provide durable coverage and improve wound healing. However, wound-related complications remain common. Reported rates of wound dehiscence for flap-based closures range from approximately 10% to 36%, and infection and seroma formation continue to be major concerns. This prospective study evaluates whether the use of Irrisept (0.05% chlorhexidine gluconate) as an antimicrobial irrigation solution during flap closure can reduce these complications compared with standard irrigation using normal saline. The study will assess safety and effectiveness by comparing the rates of postoperative infection, seroma, hematoma, wound dehiscence, and time to complete wound healing between the two groups. Participants will be adults undergoing bilateral gluteal fasciocutaneous flap closure with implantation of the Myriad extracellular matrix for treatment of pilonidal disease. All other aspects of surgical care will follow standard practice. Participants will be monitored after surgery for healing progress and any treatment-emergent adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Irrisept 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.
Sterile 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.
Surgery Group LA
Los Angeles, California, United States
RECRUITINGTreatment-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 frame: From the day of surgery through 3-month postoperative follow-up
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.
Time frame: Up to 3 months after surgery
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.
Time frame: Up to 3 months after surgery
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.
Time frame: Up to 3 months after surgery
Wound Dehiscence
Proportion of participants who experience wound separation (partial or complete) requiring additional wound care, packing, or procedural management.
Time frame: Up to 3 months after surgery
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