Abstract
Background
Surgical site infection (SSI) remains a leading health care-associated complication in open abdominal surgery. Conventional wound protectors reduce SSI risk but often fail to reliably prevent contamination of the wound edges and operative field when intraoperative effluent is substantial, such as during cesarean delivery.
Device Description
We developed Viclean®, a dual-ring wound protector equipped with a waste collection bag. A newly added middle ring links the dual-ring frame to a flexible drainage system, and a support strip maintains channel patency for continuous drainage, thereby isolating effluent and preventing contact with the incision and surrounding tissues. All components are made of medical-grade thermoplastic polyurethane (TPU) to ensure biocompatibility, flexibility, and durability.
Preliminary Results
In clinical observations, Viclean® demonstrated favorable intraoperative performance. In an emergency cesarean section, amniotic fluid was rapidly diverted into the bag, preventing contamination of the incision and operative field. In an elective open left hemicolectomy, enteric effluent and irrigation fluids were effectively drained into the bag, maintaining clean and dry wound edges. Surgical teams provided positive evaluations regarding its clinical utility.
Current Status
Viclean® has completed sterility, biocompatibility, and packaging validation and operates under an ISO 13485:2016-certified quality system. Regulatory registrations have been obtained in multiple areas. The device is authorized in more than 20 countries; however, it is not yet commercially available outside China.
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