HemaClear for bloodless surgical field during limb surgery

Level of innovation

All commentators considered HemaClear to have some novel concepts, including more rapid application reducing operative time, reduction in risk of tissue damage, better limb exsanguination and lack of a need for a pneumatic machine, air cylinder or electrical supply. One commentator identified that it is a single-use, sterile, disposable device, which can be placed higher up the limb, providing a larger sterile field for surgery. The same commentator also highlighted that it must be reapplied during lengthy surgery. Other commentators stated that HemaClear represents a refinement of current limb exsanguination technologies and has likely not been taken up because of added costs and unquantified, unclear benefits. One commentator identified 2 similar technologies currently available.

Potential patient impact

Potential patient benefits were identified by all commentators. One commentator said HemaClear may reduce limb trauma and reduce ischaemic and operative times for patients having long lower-limb bypass surgeries. As a result, this would potentially reduce the effect of serious complications such as wound dehiscence, infections and pressure ulceration. Another commentator highlighted that compared with pneumatic tourniquets, the limb exsanguination and tourniquet effect is more effective and reliable, and the narrower width allows for its use in the treatment of more proximal arm fractures, ultimately resulting in less blood loss for these patients. Furthermore, the same commentator reported a case where HemaClear was able to be applied during a surgery to control unexpected bleeding, because of its rapid application and sterile properties. A different commentator identified benefits of quicker patient set up, better limb exsanguination compared with other exsanguinator devices, ability to apply HemaClear during the operation after surgically prepping the area, and no loss in pressure that can happen with current limb exsanguinators. It was also highlighted that it is less bulky and therefore may be useful in paediatric cases as a high arm tourniquet for operating on the mid to distal humerus.

Groups of patients identified by commentators who would particularly benefit from HemaClear included patients needing upper limb arterial surgery, vascular trauma surgery, below knee arterial bypass surgery, lower-limb procedures of knee, tibia, foot or ankle and upper limb surgery.

Potential system impact

Potential system benefits identified by commentators included better theatre and resource use. One commentator thought that HemaClear provides a better sterile field for surgery and potentially a reduced deep vein thrombosis rate. Furthermore, a commentator identified that there may be less surgical time lost because of avoidance of bleeding from a venous tourniquet.

Opinions on the cost of HemaClear varied among commentators. One commentator concluded that a modest reduction in operative time or rate of complications would be needed to be cost effective compared with current reusable devices in vascular surgery. Another commentator thought that HemaClear is less costly than single-use pneumatic tourniquets. It was considered similar in cost by another commentator, provided the clinical standards for reusable tourniquets are implemented.

Two commentators thought that HemaClear would replace standard care, 1 stating that this would be needed to justify the cost benefit. A different commentator emphasised replacement of current techniques would only be the case in eligible patients if the performance is satisfactory. A further commentator highlighted that HemaClear would replace pneumatic tourniquets in most cases, although there are still some cases where pneumatic tourniquets are preferable.

General comments

One commentator identified training needs for HemaClear as modest, suggesting that the device could be substituted for current techniques without changes to facilities or infrastructure. One commentator stated no additional specific safety concerns to HemaClear that are not already considered for other methods of limb exsanguination. A further commentator stated that apart from training needed and familiarity with sizing, HemaClear appears safe and easy to use. A different commentator suggested more safety evidence is needed and they would be concerned about using the device in someone with peripheral vascular disease and those at risk of deep venous thromboses and pulmonary embolisms.

The eligible population per annum was estimated to be between 5 and 10,000 by 1 commentator, and 2,000 by another commentator considering both elective and trauma cases at their hospital trust. A further commentator highlighted that the device would be suitable for between 10 and 20 patients in their practice each year, but emphasised that operative practice and tourniquet use varies among surgeons. A different commentator thought it could be used in most surgical cases under tourniquet.

Adoption issues were identified by 2 commentators, including issues of cost and the need for HemaClear to show usability, effectiveness and satisfactory cost–benefit performance. The same commentators also identified that research is needed in the form of a randomised controlled trials to evaluate the device's effectiveness in vascular reconstruction across a range of outcomes and also to look at medium to long-term follow up, in addition to risks of venous thromboembolism.