Device Dossier

NPWT Dressing Kit - Negative-pressure wound therapy system dressing set

Device Dossier for NPWT Dressing Kit - Negative-pressure wound therapy system dressing set (Negative-pressure wound therapy system dressing set, Class…

Intended purpose

The NPWT Foam or Gauze Dressing Kit with FitPad in conjunction with the Negative Pressure Wound Therapy (NPWT) Systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. When used on closed surgical incisions, the dressing Kit with FitPad is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of Negative Pressure Wound Therapy. The Dressing Kit with FitPad is appropriate for use for the following indications: Acute or sub-acute wounds Chronic wounds Dehisced wounds Pressure ulcers Diabetic/neuropathic ulcers Venous insufficiency ulcers Traumatic wounds Partial thickness burns Flaps and grafts Closed surgical incision The Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.