Clinical Data

The SNaP® Wound Care System may be discreet, but when it comes to performance, you can see the results for yourself.

Spiracur is dedicated to evidence based medicine and to providing clinicians with significant data supporting the efficacy of the SNaP® System. Since its founding in 2007, the company has undertaken a multitude of studies, including a comparative Randomized Controlled Trial. In addition, multiple papers and case studies have been published further supporting the SNaP® Wound Care System as an effective alternative to powered NPWT.

 

RCT Results

Randomized Controlled Trial Results

In April 2011, Spiracur completed enrollment of a 132-patient Randomized Controlled Trial comparing the SNaP® System directly to the KCI VAC System in a study of chronic lower extremity ulcers. The study represents the first and only prospective multi-center randomized trial comparing the efficacy of two negative pressure therapy systems in chronic wounds.

Interim Results Highlights:

Sixty-five patients were enrolled at the time of the planned interim analysis. Fifty-three patients completed at least 4 weeks of therapy. Thirty-three patients completed the study with either healing or 16 weeks of therapy.

  • Clinically proven negative pressure offered at 125 mmHg, 100 mmHg, 75 mmHg
  • Demonstrated non-inferiority in wound healing outcomes for patients completing at least 4 weeks of therapy
  • Mean application time for the SNaP® System was less than half that of the comparative system.  The VAC Therapy was 20.98 minutes (SD +/- 11.18 min), while the mean application time for the SNaP® System was 8.58 minutes (SD +/- 5.23 min)

Quality of Life Data

One of the biggest factors leading to non-compliance of a therapy is how much that therapy interferes with a patient’s quality of life. To that end, as part of the randomized controlled trial, response data was collected from patients concerning the user experience. This data covered areas such as:

  • Activities of daily living
  • Mobility
  • Sleep
  • Noise disruption
  • Social Interactions
  • Pain and comfort
  • Satisfaction with the device

Overall the SNaP® System interferes significantly less with overall activity, sleep and social interactions than the VAC Therapy System.

Clinical Papers

Below are publications written about the SNaP® Wound Care System. For complete papers, please refer directly to the referenced journal.

Comparison of Negative Pressure Wound Therapy with the SNaP® Wound Care System vs. V.A.C.® Therapy System for the Treatment of Chronic Lower Extremity Ulcers: A Multicenter Randomized Controlled Trial. 2011
Armstrong, D. G., W. A. Marston, et al.
Wound Repair and Regeneration
19; 173-180

Comparative effectiveness of the SNaP® Wound Care System. 2011
Hutton, D.W. and Sheehan, P.
International Wound Journal
8:196-205.

The SNaP® System: biomechanical and animal model testing of a novel ultraportable negative-pressure wound therapy system. 2010
Fong, K. D., D. Hu, et al.
Plast Reconstr Surg
125(5): 1362-1371.

The SNaP® Wound Care System: a case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds. 2010
Lerman, B., L. Oldenbrook, et al.
J Diabetes Sci Technol
4(4): 825-830.

Analysis of the SNaP® Wound Care System, a negative pressure wound device for treatment of diabetic lower extremity wounds. 2010
Landsman, A.
J Diabetes Sci Technol
4(4): 831-832.

Initial Clinical Experience Using a Novel Ultraportable Negative Pressure Wound Therapy Device. 2010
Fong, K. D., D. Hu, et al.
Wounds
22(9): 230-236.

Evaluation of Chronic Wound Treatment with the SNaP® Wound Care System vs. Modern Dressing Protocols. 2010
Lerman, B., H. Oldenbrook, et al.
Plast Reconstr Surg.
126: 1153- 1161.