New study results show that canisterless negative pressure wound therapy is superior to the traditional variant of vacuum therapy in terms of reduction of wound area, depth and volume in diabetic foot syndrome and venous leg ulcers.
The newly published randomized controlled multicenter clinical trial (RCT) was conducted in the United States and Canada and compared the efficacy and safety of canisterless negative pressure wound therapy (PICO sNPWT) with conventional negative pressure wound therapy (tNPWT) in the treatment of patients with lower extremity ulcers lasting longer than 4 weeks [1].
Effective and sustainable wound care
The duration of the study was 12 weeks [1]. A total of 164 patients were randomized to receive either PICO sNPWT or tNPWT. Compared to tNPWT, greater average reductions in wound area (39.1%, p<0.001), wound depth (32.5%, p=0.014), and wound volume (91.1%, p=0.013) were measurable in the sNPWT condition [1]. The number of patients in whom wound closure was achieved within 12 weeks increased by 51% with PICO sNPWT compared with tNPWT. In addition, the wound dressing had to be changed less frequently than with tNPWT – on average, 6.8 fewer changes and 3.4 days longer wearing time were observed. In addition, compared with tNPWT, there were fewer patients with adverse events and overall satisfaction was greater with PICO sNPWT.
PICO is a mobile negative pressure wound therapy system for single use. It consists of a self-adhesive wound dressing, which is connected to a pump via a tube. This is powered by two AA batteries and builds up a preset negative pressure of 80 mmHg for one week. Different lengths and widths are available. The medical technology company Smith & Nephew [2] has developed PICO, an active system based on negative pressure wound therapy (also: vacuum therapy or NPWT) to treat incisions, skin grafts, and acute and chronic wounds. Wound healing is accelerated and the risk of suture dehiscence and infection is reduced [2].
Foot ulcers in diabetics: growing health problem
Chronic wounds are associated with increased morbidity and mortality and result in high healthcare costs [3]. This trend is expected to increase in the future due to the growing elderly population and rising diabetes rates [3]. The most common causes of chronic wounds are venous or arterial insufficiency, diabetes, and effects of local pressure [4]. Chronic wounds can be treated using conventional negative pressure wound therapy [5], but it is complex to use and limits patients’ mobility [6]. The canisterless negative pressure wound therapy represents an optimized patient-friendly alternative in the field of vacuum therapy.
| “By using PICO as an early intervention for lower extremity ulcers, we were able to have a good early impact on wound healing, improving patients’ quality of life by allowing faster and more reliable wound healing and allowing patients to remain mobile and continue treatment at home.”
Rosemary Hill, a nurse practitioner specializing in wound |
Diabetic foot syndrome refers to pathological changes in the feet of diabetics. As a result of impaired glucose metabolism, peripheral nerve damage may occur (diabetic polyneuropathy), which contributes to a weakening of the tension state of the foot muscles [7]. This changes the stress zones and pressure points. Limited pain sensation and repetitive pressure in daily life favor the development of ulcers or necrosis [8]. Unsuitable footwear and limited joint mobility are other factors that promote ulceration. Approximately 0.8-10% of all diabetics develop foot ulcers during the course of the disease [7]. Approximately half of those affected have relevant pAVD [8]. Important preventive measures of ulcers include pressure-relieving footwear and timely treatment of preulcerative foot lesions [8]. If foot ulcers have already formed, local wound treatment is one of the therapeutic options [7].
Literature:
- Kirsner R, et al: A Prospective, Randomized, Controlled Clinical Trial on the Efficacy of a Single-use Negative Pressure Wound Therapy System, Compared to Traditional Negative Pressure Wound Therapy in the Treatment of Chronic Ulcers of the Lower Extremities. Wound Rep Regen 2019, [Epub ahead of print], https://doi.org/10.1111/wrr.12727.
- Smith & Nephew: www.smith-nephew.com/deutschland/fachgebiete/wundmanagement/kanisterlose-npwt/pico/
- Powers JG, et al: Wound healing and treating wounds: chronic wound care and management. J Am Acad Dermatol 2016; 74(4): 607-625.
- Werdin F, Tenenhaus M, Rennekampff HO: Chronic wound care. Lancet 2008; 29; 372(9653): 1860-1862.
- Birke-Sorensen H, et al: Evidence-based recommendations for negative pressure wound therapy: treatment variables (pressure levels, wound filler and contact layer) steps towards an international consensus. J Plast Reconstr Aesthet Surg 2011; 64 Suppl: S1-16.
- Hurd T, Trueman P, Rossington A: Use of a portable, single-use negative pressure wound therapy device in home care patients with low to moderately exuding wounds: a case series. Ostomy Wound Manage 2014; 60(3): 30-36.
- Tylla A, Prennig T: Diabetic foot syndrome and wound infection – interdisciplinary infection management. Slide presentation, Alfred Tylla, MD & Thorsten Prennig, 02. Nuremberg Wound Congress, Dec. 06, 2019.
- Morbach S, et al: Diabetic foot syndrome…. Diabetology 2017; 12 (Suppl 2): S181-S189.
- Pressemitteilung 23.01.2020, www.businesswire.com/news/home/20200123005374/de/
- Smith & Nephew: Project Opal PICO 7 System Stability Testing, Initial Time Point. Internal Report. DS/17/253/R. October 2017.
- Brownhill R, et al: Pre-clinical Assessment of a No-canister, Ultra-portable, Single use Negative Pressure Wound Therapy (sNPWT) System in a Porcine Model of Wound Healing: Unlocking its Mode of Action. Poster, SAWC, May 7-11, 2019, San Antonio, Texas.
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