Measurement of the local physiological effects of a single use topical negative pressure device in healthy volunteers– The PICO-1 Study

AimsThis study aimed to investigate the effects of a Single use Negative Pressure Wound Therapy (sNPWT) device upon tissue perfusion, oxygenation and pressure, in the intact skin of healthy volunteers. Methods12 healthy volunteers wore a PICO™ device 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 prior to, and following, dressing application without activation. Macrovascular flow and transduced needle pressure measures were recorded at 0, 30 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 after 7 days, both with the dressing and following dressing removal. ResultsThe device was associated with a measurable increase in perfusion of the limb. Superficial tissue oxygenation adjacent to the dressing was reduced during wear, whilst deeper tissue demonstrated an increase in oxygenation levels. Superficial skin perfusion was seen 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. ConclusionSingle-use NPWT produces 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

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