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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Currently participating or has participated in another clinical study within 30 days prior to enrollment
- •Pregnant or lactating women
- •Any subject who, at the discretion of the Investigator, is not suitable for inclusion in the study
研究组 & 干预措施
Arm 1: Irrisept (0.05% Chlorhexidine Gluconate) Irrigation
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.
干预措施: Irrisept (0.05% chlorhexidine gluconate) (Device)
Arm 2: Normal Saline Irrigation (Standard of Care)
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.
干预措施: Normal Saline (Other)
结局指标
主要结局
Treatment-Emergent Adverse Events (TEAEs)
时间窗: From the day of surgery through 3-month postoperative follow-up
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.
次要结局
- Time to Complete Wound Healing(Up to 3 months after surgery)
- Postoperative Infection Rate(Up to 3 months after surgery)
- Wound Dehiscence(Up to 3 months after surgery)
- Seroma or Hematoma Formation(Up to 3 months after surgery)
研究者
Yosef Nasseri, MD
Principal Investigator
Nasseri,Yosef MD