A Prospective, Randomized Trial of Vacuum-Assisted Closure Versus Standard Therapy of Chronic Non-Healing Wounds

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Disclosures

Wounds. 2000;12(3) 

In This Article

Abstract and Introduction

Abstract

Chronic, open, nonhealing wounds pose a continual challenge in medicine. Our objective was to evaluate vacuum-assisted closure (VAC)* therapy's ability to improve the healing rate of chronic wounds compared to the traditional saline-wet-to-moist (WM) dressings. Twenty-four patients with 36 chronic, nonhealing wounds were enrolled in the study after obtaining proper consent. Subjects were randomized to the VAC group or the control group. Biopsies and wound measurements were obtained by blinded independent wound evaluators. The most significant difference was the change in depth of 66 percent for VAC compared to 20 percent for WM (p<.00001). Histologically, the groups exhibited different characteristics. In the WM group, 81 percent (n=13) displayed inflammation and fibrosis. The chief characteristic of the VAC group was granulation tissue formation in 64 percent (n=9) of those wounds. The VAC system should be used to obtain wound closure, especially of chronic nonhealing wounds with great depth, rather than the traditional saline WM dressings.

Introduction

There are over 2.8 million patients with chronic wounds treated at a cost of billions of dollars per year in the United States.1 Chronic, open, nonhealing wounds pose a continual challenge in medicine since the treatment is variable and there are no documented consistent responses. Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. This sequence begins with removal of debris, control of infection, clearance of inflammation, angiogenesis, deposition of granulation tissue, contraction, remodeling of the connective tissue matrix, and maturation. When wounds fail to undergo this sequence of events, a chronic open wound without anatomical or functional integrity results.2 Clinically, chronic wounds may be associated with pressure, trauma, venous insufficiency, diabetes, vascular disease, or prolonged immobilization. The treatment of chronic, open wounds is variable and costly, demanding lengthy hospital stays or specialized home care requiring skilled nursing and costly supplies.

Rapid healing of chronic wounds could result in decreased hospitalization and an earlier return of function. A product that improves the healing process could greatly decrease the risk of infection, amputation, and length of hospital stay, and result in an estimated potential annual savings of a billion dollars of healthcare cost.1 A device and technology that may increase the rate of healing of chronic wounds has recently been introduced. The device utilizes a new subatmospheric technique: vacuum-assisted closure (VAC)*. The VAC technique involves placing an open-cell foam dressing into the wound cavity and applying a controlled subatmospheric pressure (typically 125mmHg below ambient pressure). The technique removes chronic edema, leading to increased localized blood flow, and the applied forces result in the enhanced formation of granulation tissue.3,4 This device aids wound healing by applying localized negative pressure that removes fluid from the wound and stimulates the growth of granulation tissue to obtain closure.3,4 The technique may be applied to acute, subacute, and chronic wounds.3 The rapid healing of wounds should not only decrease hospital stay, but may avoid extensive plastic surgery flap closure of some wounds. Patients who are unable to tolerate a surgical procedure should be effectually treated to complete wound closure with minimal pain and suffering at the lowest cost and hospitalization. Any improvement in wound healing provided by the VAC system could also eliminate the additional morbidity of infection, pain, humiliation, and depression associated with having these chronic wounds.

The VAC is cleared for marketing by the FDA for clinical use. Argenta, et al.3 have previously described the use of the VAC device to enhance healing and promote closure of a variety of open wounds. However, Argenta's study was reported as a series of clinical cases and was not tested against a randomized control group with strict inclusion and exclusion criteria. The standard and most common wound care among physicians remains wet-to-moist (WM) gauze dressings, despite the multiple new wound treatment modalities available. Traditional therapy of chronic, open wounds entails at least twice daily or more frequent and often painful dressing changes performed by skilled nursing staff. The VAC system provides a closed system with dressings that are changed every 48 hours.

Our objective was to test the ability of the VAC to obtain rapid wound closure compared to traditional saline WM dressings.

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