The British journal of surgery
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Randomized Controlled Trial Multicenter Study Clinical Trial
Prospective study of 713 below-knee amputations for ischaemia and the effect of a prostacyclin analogue on healing. Hawaii Study Group.
In 51 hospitals in six European countries 713 patients requiring below-knee amputation for ischaemic disease were studied prospectively. The patients were allocated randomly to receive standard postoperative treatment or standard treatment plus intravenous infusion of the prostacyclin analogue iloprost for 6 h per day over 14-21 days. Healing of the amputation stump and the need for reamputation at a higher level were similar in the two groups. ⋯ Preoperative characteristics were analysed as possible risk factors or markers for primary healing, reamputation and death. Previous arterial reopening procedures (surgical or radiological) almost doubled the chances of primary stump healing (P < 0.05). The surgeon's assessment of the likelihood of healing was wrong in 21 per cent of cases in which the operating surgeon thought that healing would probably occur and in 52 per cent of those in which it was thought healing was improbable.