The local physiological effects of a single-use topical negative pressure device in healthy volunteers: the PICO-1 study

Abstract

Objective: This study aimed to investigate the effects of a single-use negative pressure wound therapy (sNPWT) device on tissue perfusion, oxygenation and pressure in the intact skin of healthy volunteers. Method: Healthy volunteers wore a PICO sNPWT device (Smith+Nephew, UK) on their right medial calf for one week. Perfusion, tissue oxygenation and tissue pressure were recorded in superficial and deep tissues over a period of seven days. At the baseline visit, measurements were recorded before and after dressing application without activation. Macrovascular flow and transduced needle pressure measures were recorded at 0 minutes, 30 minutes and 60 minutes after device activation. Superficial tissue perfusion and both oxygenation measures were recorded continuously over the hour following activation. All outcome measures were repeated at 24 hours and again after seven days, both with the dressing and following dressing removal. Results: The device was associated with a measurable increase in perfusion of the limb in 12 healthy volunteers. Superficial tissue oxygenation adjacent to the dressing was reduced during wear, while deeper tissue demonstrated an increase in oxygenation levels. Superficial skin perfusion was observed to differ between skin overlying muscle and that overlying bone. Pressure in tissue underneath the dressing pad was increased throughout dressing wear and returned to baseline levels on dressing removal. Conclusion: sNPWT produced measurable changes in local physiology in healthy volunteers with intact skin, despite the absence of a wound. Effects may differ according to anatomical site and the composition of underlying tissues. Other factors that promote healing were not explored in this study. Declaration of interest: This study was funded by Smith+Nephew investigator-initiated grant IIS 684. The funder had no input into study design, conduct, analysis, manuscript preparation or dissemination. The authors have no conflicts of interest to declare.