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 V.A.C. System in a study of chronic lower extremity ulcers. Patients were recruited from 17 sites across the US. The study represents the first and only prospective multi-center randomized controlled trial comparing the efficacy of two negative pressure therapy systems in chronic wounds.

These data demonstrate that the SNaP® Wound Care System can deliver the same wound healing outcomes as electrically-powered pumps while interfering significantly less with overall activity, sleep, and social interactions than the V.A.C.® Therapy System. No other ultraportable NPWT device is supported with such powerful data.

Results Highlights:

One hundred and thirty-two patients were randomized to either the SNaP® System (N=64) or V.A.C. System (N=68) treatment arms. Of these, eighty-three patients completed the study with either healing or 16 weeks of therapy. Fourteen subjects dropped from the study prior to initiating treatment and three subjects dropped after treatment initiation, but prior to any follow-up assessments, resulting in 115 subjects (N=59, SNaP®, N=56 V.A.C.) with follow-up data available for analysis.

  • Clinically proven negative pressure offered at 125 mmHg, 100 mmHg, 75 mmHg.
  • Demonstrated non-inferiority in wound healing outcomes for patients at 4, 8, 12, and 16 weeks – indicating that the SNaP® System was not significantly different than the V.A.C. System in promoting complete wound closure.
  • Mean application time for the SNaP® System was about half that of the comparative system.  The V.A.C. Therapy mean application time was 18.26 minutes (SD +/- 9.37 min), while the mean application time for the SNaP® System was 10.20 minutes (SD +/- 8.25 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 their 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 V.A.C. Therapy System.

SNaP quality of life results

 

 

Clinical Papers

Below are publications written about the SNaP® Wound Care System. Click on links to access papers online.

Comparative Effectiveness of Mechanically and Electrically Powered Negative Pressure Wound Therapy Devices: a Multicenter Randomized Controlled Trial
2012
Armstrong, D. G., W. A. Marston, et al.
Wound Repair and Regeneration
20(3); 332-341.

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.

Clinical Case Studies

The case studies below are examples of the efficacy of the SNaP® Wound Care System. Please click on the links below to download the case studies.

Clinical Case Study: Diabetic Hallux Wound
Clinical Case Study: Diabetic Wound
Clinical Case Study: Diabetic Amputation Wound – Healing Progression
Clinical Case Study: Skin Graft Wound
Clinical Case Study: Sacral Pressure Sore in a Paraplegic Male
Clinical Case Study: Heel Pressure Ulcer
Clinical Case Study: Surgical Site Wound
Clinical Case Study: Partial Toe Amputation
Clinical Case Study: Burn Complications
Clinical Case Study: Diabetic Foot Ulcer

Clinical Articles

Below are links to clinical articles published in industry journals, highlighting the efficacy of the SNaP® Wound Care System.

An Historical Perspective on Negative Pressure in Wound Care

August 2013, Today’s Wound Clinic - This article reflects on the progress we have seen in NPWT in general and compares the usage of electrical and mechanical NPWT, which should be considered as yet another tool within the wound care practitioner’s armamentarium.
Click here for the full article

Use of Mechanically Powered NPWT: A Clinical Case Study Series

August 2013, Today’s Wound Clinic - This article provides an overview of mechanically powered NPWT and includes a clinical case study series with photos that follow the patient’s trajectory of care.
Click here for the full article

Emerging Insights on Negative Pressure Wound Therapy

August 2013, Podiatry Today - Negative pressure wound therapy (NPWT) has become an indispensable tool for wound care for many physicians. The authors examine the research on NPWT, evaluate the newest devices on the market and provide guidance for getting reimbursement.
Click here for the full article

Handling the Sequelae of Breast Cancer Treatment: Use of NPWT to Enhance Patient Independence

March 2013, Journal of Wound Care - This case study describes the management of a 38-year-old female cancer patient with a portable, non-electrical negative pressure wound therapy device, suggesting benefits in terms of healing, patient independence and improved quality of life.
Click here for the full article

A Mechanically Powered Negative Pressure Device used in Conjunction with a Bioengineereed Cell-based Product for the Treatment of Pyoderma Gangrenosum: A Case Report

September 2012, Ostomy Wound Management  –  A 76-year-old male patient presented with Pyoderma gangrenosum (PG). After 9 months of treatment with topicals, steroids, and local wound care, the wound had grown in size. He was switched to a bioengineered cell-based product used with a mechanically powered negative pressure wound therapy device and treated until the wound completely healed.
Click here for the full article

Managing Diabetic Foot Ulceration with a New, Highly Portable NPWT Device

September 2012, Wounds International – This article examines the use of a highly portable negative pressure wound therapy (NPWT) in the management of diabetic foot ulceration, a significant sequelae of diabetes that affects some 61,000 people in the UK at any given time.
Click here for the full article

Treatment of a Diabetic Hallux Ulcer with Ultraportable Negative Pressure Wound Therapy: A Case Study

April 2011, Ostomy Wound Management – A 52-year-old man with a history of diabetes mellitus presented with a left hallux ulcer that had been present for 9 months. The patient was treated with the ultraportable NPWT device for 5 weeks with an oral antibiotic. The wound decreased in size, allowing the patient to be transitioned to treatment with a bioengineered skin substitute, bringing the wound to closure.
Click here for the full article