Smith+Nephew has announced the publication of results from a new randomised controlled trial (RCT) demonstrating that the use of the PICO single-use negative pressure wound therapy system (sNPWT) significantly reduces wound area, depth and volume, compared with traditional negative pressure wound therapy (tNPWT) in patients with venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs).
According to a statement, chronic wounds cause substantial morbidity and mortality and can lead to significant medical costs. In the USA alone, chronic wounds affect six million people, with increasing numbers anticipated in growing elderly and diabetic populations. Moreover, one study showed that in a single year, chronic wounds cost US$9.7 billion in the USA.
Venous or arterial insufficiency, diabetes, and local-pressure effects are the most common causes of chronic wounds. These wounds can be managed with traditional negative pressure wound therapy (tNPWT), but it can be complex to use and also limits patient mobility.
The randomised, controlled, multicentre study was conducted at 16 centres in the USA and two centres in Canada, comparing the efficacy and safety of PICO sNPWT with tNPWT in the management of patients with lower extremity ulcers with a longer duration than four weeks over 12 weeks. In total, 164 patients were randomised to receive either PICO sNPWT or tNPWT.
A greater average reduction in wound area of 39.1%, depth of 32.5% and volume of 91.1%, versus tNPWT, was observed with PICO sNPWT. In addition, there was a 51% relative increase in the number of patients achieving wound closure at 12 weeks with PICO sNPWT versus tNPWT.
Dressing changes were also less frequent with PICO sNPWT than with tNPWT, with 6.8 fewer changes and 3.4 days longer wear time reported. Overall satisfaction was greater with PICO sNPWT as well, and fewer patients had adverse events with PICO sNPWT than with tNPWT.
“I decided to use PICO sNPWT to treat a diabetic foot ulcer, after achieving excellent results using the therapy on skin flaps and full thickness skin grafts” said Rosemary Hill, Wound Ostomy Nurse at Lions Gate Hospital, Vancouver.
“By introducing PICO as an early intervention for lower extremity ulcers, we’ve been able to help kickstart wound healing and ultimately improve the quality of life for patients who experience a faster and more predictable healing trajectory, as well as being mobile and able to resume treatment at home.”
The unique PICO sNPWT dressing includes the proprietary AIRLOCK Technology for uniform and consistent delivery of therapeutic NPWT across a wound and the surrounding zone of injury. By minimising the need for fillers and reducing dressing change frequency compared with traditional NPWT, PICO sNPWT helps healing to progress undisturbed, contributing to faster healing times, improved quality and distribution of granulation tissue, and more consistent re-epithelialisation.
PICO sNPWT has a strong evidence base with 103 published papers, of which 21 are published RCTs and 65 are unique clinical studies.