A Multi-Center Prospective Clinical Evaluation and Cost Comparison of a New Silver Oxysalts Dressing

Purpose.

Some commonly used silver dressings release silver into the wound causing stinging and pain; others have not demonstrated 7 day antimicrobial sustainability.1-3 In addition, the high cost of silver dressings can be a detriment to their use. Clinicians in multiple clinical sites evaluated wound healing outcomes using a new 3-layer dressing coated with silver oxysalts*. The dressing utilizes 75% less silver than competitive products to achieve 7-day sustained antimicrobial activity.4 A concentration of approximately 0.4 mg/cm2 results in a slow pH shift which reduces stinging, pain, and tissue staining.

Methodology.

A prospective open label non-blinded clinical evaluation of 50 patients with wounds of various etiologies was conducted in multiple outpatient facilities across the U.S. Investigators evaluated subjects for 4 weeks or less, based on wound characteristics. The silver primary dressing* was left on wounds for up to 7 days. Clinicians documented weekly using the BWAT Assessment Tool; patient pain was assessed using the Visual Analog Pain Scale.

Clinicians evaluated the bacterial balance or critical colonization levels using common key characteristics: change in wound size, increased pain, exudate and necrotic tissue.5-9 In addition, clinicians calculated total treatment cost using the new dressing compared with the silver dressing currently used in their facility.

Results.

A total of 50 patients (25 men and 25 women) were enrolled in the study. The median and mean patient age was 69 years (range 33-95 years) and the median duration of the wound prior to enrollment in the study was 3.6 months (range, 2 days to 24 months). Due to incorrect dressing application in the second week of evaluation, one patient (ET01-047) was excluded from the analysis. There were no reported adverse effects.

Wound types evaluated in the clinical case series included; venous (n=18), diabetic (n=5), pressure (n=3), and arterial (n=3) ulcers; surgical (n=10); skin tears (n=3); trauma (n=3); and other wounds (n=4) including edema and lymphedema.

Clinicians reported improvement in most wound characteristics, most notably increase in granulation tissue, and decrease of inflammation, pain, debris and odor. For many patients, pain level dropped to zero within 1 week. Upon treatment with the silver oxysalts dressing, previously stalled wounds healed in less than 4 weeks. No stinging and little or no staining as compared to other silver dressings were consistently reported. The new dressing cost was 25-30% lower that other silver dressings.

References.

1) Schorrock SM, M.Sc. Thesis, Science and Biomed. Eng. Worchester Polytechnic Institute, May, 2000; 2) Gethin G, Wounds UK, 2007, 3(3), 52-55; 3) Parsons D, Bowler PG, Myles V, Jones S, Wounds, 2005, 17(8), 222-232; 4) Djokic SS, J. Electrochem. Soc., 2004, 151(6), C659-C364; 5) Cutting KF, Harding MB., JWC, 1994, 3(4), 198-201; 6) Gardner SE, et al., Wound Rep. Regen., 2001, 9(3), 178-185; 7)

Sibbald RG, et al., 2003, OWM, 49(11), 24-51; 8) Sibbald RG, et al., Wounds UK, 2007, 3(2), 25-46; 9) Woo KY, Sibbald RG, OWM, 55(8), 40-48; 10) Bates-Jensen BM, UCLA Dissertation Abstracts International, 1999, 59(11)

* exsalt™ SD7 Wound Dressing, Exciton Technologies, Inc., Edmonton, Alberta, Canada..

Glenda Motta, RN, MPH, ET, GM Associates, Inc. Loveland, CO Diane Merkle APRN, MSN, CWOCN, PhD(c), Bridgeport Hospital Wound Healing and Hyperbaric Center , Bridgeport, CT

Catherine T. Milne APRN, MSN, BC-ANP/CNS, CWOCN Darlene Saucier APRN, MSN, BC-FNP, CWCN Connecticut Clinical Nursing Associates, LLC, Bristol, CT

ET01-008 Week 1

ET01-008 Week 2

ET01-008 Week 3

Conclusions. • The higher oxidation state silver oxysalts dressing is effective for chronic and critically colonized wounds • 45 % of patients’ wounds healed in an average of 2.9 weeks • 80 % (CI = 95%, R2 ≥ 0.85) of patients’ wounds were predicted to heal within 12 weeks as per BWAT projections10 • Complete remission of indicators of critical colonization observed in > 60 % of patients during the course of treatment5-9 • 93 % of patients perceived reduced pain over the course of treatment and no patient reported pain upon application or removal • Clinicians observed null or minimal staining • The higher oxidation state silver oxysalts wound dressing was observed to be safe and gentle for various wound etiologies • On average, the cost savings using the new silver oxysalts wound dressing was 48% per dressing change in comparison to the currently used product

Participating Investigators. Mary Haddow RN-BC, CWCN, Community Care; Lawrence LoDico III, Atlantic Medical Supply; Eric Lullove, DPM, CWS, FACCWS, Happy Healthy Feet; Diane Merkle, APRN, CWOCN, Bridgeport Hospital; Catherine Milne, ARPN, MSN, CS, CWOCN; Marta Ostler, PT, CWS, CLT, Northeast Wyoming Wound Clinic; Tim Paine, PT, CWS, FACCWS, Symmetry Physical Therapy; Michael Clark Reed, MSPT, PT; Cheryl Salmon, PT, Wound Care at Ogden Regional; and Darlene Saucier, Connecticut Clinical Nursing Associates LLC.