HemaClear for bloodless surgical field during limb surgery

The technology described in this briefing is HemaClear. It is used for limb exsanguination during limb surgery to provide a bloodless surgical field.

The innovative aspects are that it is a single-use sterile device, which the company claims is quicker and simpler to use and reduces the number of adverse events compared with existing devices. It may also be used outside of the operating theatre (for example, in a procedure room for minor cases).

The intended place in therapy would be as an alternative to the pneumatic tourniquet system in people needing limb surgery where a bloodless field is needed.

The main points from the evidence summarised in this briefing are from 6 studies: 3 prospective randomised comparative studies, 2 retrospective comparative studies and 1 mixed retrospective/prospective comparative study. Out of a total of 539 patients, 328 patients used the device (named as S‑MART or HemaClear depending on the date of the study) in the operating theatre. They show that the device may be as effective as pneumatic tourniquets in providing a bloodless field in the adult population.

Key uncertainties around the evidence or technology are that there is uncertainty surrounding some outcomes such as pain and complications and a lack of medium- to long-term follow up.

The cost of HemaClear is between £15.95 and £41.80 (excluding VAT) per unit. The resource impact could be lower if its use shortened surgery time or reduced the number of adverse events.