In 1995, the Food and Drug Administration approved the use of a negative pressure device on chronic, non-healing wounds. The device uses a vacuum to remove tissue from wounds that have failed to close with more traditional protocols. The process, called vacuum-assisted closure, or VAC, is accepted in the United States as a viable method of wound closure. Nearly five years later, Medicare has approved the treatment for Part B reimbursement, allowing millions of Americans the opportunity to utilize the device in their homes.
Diabetic foot ulcers and pressure ulcers are two types of non-healing chronic wounds that afflict many people in the United States and worldwide. One in every ten hospital patients in the United States suffers from pressure ulcers; two million people worldwide suffer from diabetic foot ulcers. There are many accepted treatments for chronic non-healing wounds, including biological treatments made possible by advances in tissue engineering and growth factors. Vacuum-assisted closure is an option for patients who suffer from non-healing wounds and have not recived relief from more traditional methods of treatment.
The device utilizes a negative pressure technique to drain fluid from the wound bed. The negative pressure technique accelerates granulation tissue formation, an important step in wound healing. In chronic non-healing wounds, the presence of fluid often impairs the healing process because it impedes granulation and provides a breeding ground for microorganisms and bacteria. Negative pressure techniques help draining wounds in the healing process by relieving some of the fluid pressure in the area and promoting granulation, leading to blood vessel formation and healthy tissue growth. In addition, negative pressure can draw the wound edges together. However, in larger wounds, a patient may still require skin grafts or other additional therapies after receiving VAC treatment.
The KCI vacuum-assisted closure device, called VAC for short, consists of a porous dressing sponge attached by an evacuation tube to a collection container and a negative pressure pump. Before applying the device, a clinician removes all of the nonviable tissue in the wound bed. The patient places the sponge dressing directly on the wound, avoiding contact with the skin. For large wounds, several dressings may be necessary, as long as they continue to provide direct contact with the area.
The patient or caregiver affixes the device with transparent adhesive tape, forming an airtight seal around the wound. When the device is turned on, it draws fluid from the wound that would normally hinder the healing process. Patients use the device continuously for a period of 48 hours, at which point they change the dressing and continue to use the device for intermittent cycles, changing the dressing every two days. The average length of time a patient undergoes the VAC technique is just over eight weeks.
Not every patient suffering from chronic non-healing wounds is a candidate for negative pressure therapy. More standrad treatments modalities are generally tried first, and if they fail, a physician may recommend VAC. Patients suffering from severe peripheral vascular disease may find other treatments more beneficial. In addition, patients with malignant wounds should not use VAC. Patients with active bleeding, or who are taking anticoagulants might consider other options. Finally, clinicians should avoid applying the VAC dressing to exposed arteries or veins.
Negative pressure techniques have demonstrated that they have a place in the world of wound management. Clinicians accept vacuum-assisted closure as a method of wound closure that can assist patients with wounds that resist closing, and help them return to healthy living.
Medicare’s approval of VAC for reimbursement has the potential to save approximately $1,925 per patient, according to The Weinberg Group. In addition, patients can use VAC in their homes. The Mini-VAC, a portable device the size of a 35mm camera, allows ambulatory patients the ability to utilize negative pressure therapy without compromising their daily lives. Both VAC and Mini-VAC are eligible for Medicare reimbursement, effective October 1, 2000.
Kinetic Concepts, Inc.