Viclean®: A Novel Wound Protector Equipped With a Waste Collection Bag for Abdominal Surgery

Area of Science:

• Surgical innovation
• Medical device development
• Infection control

Background:

• Surgical site infection (SSI) is a significant healthcare-associated complication in open abdominal surgery.
• Conventional wound protectors have limitations in preventing contamination from substantial intraoperative effluent, especially during cesarean deliveries.
• Effective wound protection is crucial for reducing SSI risk.

Purpose of the Study:

• To introduce and evaluate Viclean®, a novel dual-ring wound protector with an integrated waste collection system.
• To assess the device's ability to isolate the operative field and wound edges from intraoperative effluent.
• To determine the clinical utility and performance of Viclean® in preventing contamination during open abdominal surgeries.

Main Methods:

• Development of Viclean®, a dual-ring wound protector made of medical-grade thermoplastic polyurethane (TPU) with a waste collection bag and flexible drainage system.
• Clinical observations of Viclean® performance during an emergency cesarean section and an elective open left hemicolectomy.
• Evaluation of device biocompatibility, sterility, and packaging validation under an ISO 13485:2016 quality system.

Main Results:

• Viclean® effectively diverted amniotic fluid during an emergency cesarean section, preventing incision and operative field contamination.
• The device successfully drained enteric effluent and irrigation fluids during an open left hemicolectomy, maintaining clean and dry wound edges.
• Surgical teams reported positive evaluations regarding the clinical utility of Viclean®.

Conclusions:

• Viclean® demonstrates favorable intraoperative performance in managing substantial effluent during open abdominal surgeries.
• The device effectively isolates the surgical site from contamination, potentially reducing the risk of surgical site infections.
• Viclean® has completed necessary validations and obtained regulatory approvals in multiple regions, indicating its readiness for wider clinical application.