This randomized controlled study allocated patients undergoing IIB surgery into three treatment arms (perioperative high-dose oxygen, extended warming, and a synthetic prostacyclin) or a control group. The primary outcome was accumulation of hydroxyproline (OHP, collagen surrogate marker) as collected in polytetrafluoroethylene implants on day 5. Secondary outcomes included levels of growth factors and cytokines, and tissue oxygenation of the wound and foot as measured by hyperspectral technology and ankle-brachial pressure index. Clinical outcomes were observed to day 30, with long-term follow-up of 12 mo.
Seventy-one patients completed the study. Comparing treatment groups with the control at day 5, there were no differences in OHP, growth factors or cytokines levels, or improvement in tissue oxygenation at the surgical incision. However, there was more flow to the foot (HT-SUM (%) change) in the Ilomedin group compared to control (0% versus -14.6%, P = 0.045). HT-deoxy was higher at the peripheries in the oxygen and temperature groups, suggesting decreased tissue oxygenation.
The perioperative treatments did not dramatically improve oxygenation or healing of the surgical wound in IIB surgery; however, Ilomedin may result in greater flow to the peripheries.