Advice
The technology
The technology
The TopClosure Tension Relief System (TRS; IVT Medical) is a skin stretching system to help close medium to large soft tissue wounds. It is designed to allow skin to be stretched to reduce the tension across a wound that would otherwise be under high mechanical stress or tension during closure, for example, wounds over joints or where large areas of skin have been removed after tumour excision. Reducing tension across such wounds aims to improve primary wound closure, reduce the risk of wound failure by relieving tension on stitches, and avoid the need for skin grafts, flap closures or internal tissue expanders. The TopClosure TRS can also act as a topical tension-relief platform for tension sutures.
The manufacturer claims that using the TopClosure TRS can prevent ischaemia and tissue tears caused by tension sutures used to close high-stress wounds. The system is designed to distribute tension more evenly around the closed wound and away from the wound's edges, to avoid rupture of the wound. This may improve the quality and look of the resulting scar.
The technology is made up of 2 attachment plates, which are fixed to the skin on each side of the wound, using either adhesive (described as 'non-invasive use') or by skin staples or stitches (described as 'invasive use'). The plates cover a relatively large area, to spread the tension across the wound. 'Invasive use' of the TopClosure TRS is recommended by the manufacturer for wounds that are under very high stress, for which tension sutures would not be appropriate (for example, wounds created by removing a large area of skin or for wounds over poorly vascularised areas such as bones and tendons).
After fixing the attachment plates to the skin, a flexible approximation strap is threaded through them to connect them together. The strap is gradually pulled through the attachment plates, using a lock-release ratchet mechanism similar to a cable-tie, so that the system tightens and moves the 2 sides of the wound closer together. This procedure is done by a healthcare professional who has been trained in using the technology, such as a surgeon or a wound healing specialist nurse. They also decide how often and over what period the strap is tightened, based on the size and nature of the wound being treated. This gradual movement is described as a 'mechanical creep mechanism' because it allows the wound edges to be pulled together gradually over a period of time. The TopClosure TRS can be used for delayed primary wound closure after surgery.
The TopClosure TRS can be used as a method of temporary skin stretching during surgery, known as 'stress–relaxation'. This method involves using the TopClosure TRS invasively, with staples to attach the plates to the skin and with tension sutures connecting the attachment plates instead of the approximation strap.
The TopClosure TRS can also be used before surgery to temporarily stretch the skin around the area where surgery is planned, using the mechanical creep mechanism. This could avoid the need for internal tissue expanders to stretch the skin and may help primary closure of the wound. Pre-surgical stretching can be done in an outpatient clinic or at home by a trained patient or family member. The length of time for this process will depend on skin elasticity and the anticipated size and nature of the wound, as well as tension on closure.
Innovations
The TopClosure TRS is a single system that can be used for both mechanical creep and stress–relaxation and can be applied in various clinical situations.
The manufacturer claims that using the TopClosure TRS prevents undermining of the skin edges and nearby tissue, potentially decreasing the risk of dead space, seroma and haematoma formation and with the aim of reducing the need for drainage and the risk of infection.
The TopClosure TRS may simplify surgical technique and could potentially reduce hospital stay because most wound closure procedures using the device can be done under local anaesthetic.
Current NHS pathway or current care pathway
The closure of large soft tissue wounds from surgery or trauma is challenging for surgeons and there is no national guidance on this area. Immediate primary suture closure is thought to be the best approach, but may not be possible for wounds that are under high tension because of location and limited skin elasticity, such as wounds over joints and the scalp, or because of the risk of the skin tearing around the edges of the primary sutures, such as for large excision wounds (Topaz et al. 2012; Topaz et al. 2014a; Topaz et al. 2014b).
For these wounds different techniques are used, such as skin grafts, flaps or internal tissue expanders. Skin grafts involve taking healthy skin from an unaffected area of the body to cover lost or damaged skin. Grafting may be used for open fractures, large wounds, surgical removal of an area of skin (for example tumour excision) and burns. The skin graft will usually be held in place using stitches, staples, clips or special glue. The area will be covered with a sterile dressing until it has connected with the surrounding blood supply.
Skin flap surgery involves the transfer of a living piece of tissue (including the blood vessels) from one part of the body to another. Flap surgery may be used for breast reconstruction, open fractures and large wounds. In most cases, the skin remains partially attached to the body, creating a "flap" which is then repositioned and stitched over the damaged area. As flap surgery allows the blood supply to the repaired area to be maintained, there is a lower risk of the repair failing compared to a skin graft.
Tissue expansion involves inserting a balloon-like device called an expander under the skin near the area to be repaired. This is gradually filled with saline over time, causing the skin to gradually stretch and grow. Time involved in tissue expansion can vary depending on the size of the area to be repaired. If a large area of skin is involved, it can take up to 3 or 4 months for the skin to grow enough. Once the skin has expanded sufficiently, a second operation is needed to remove the expander and reposition the new tissue (NHS Choices).
These methods are complex and are associated with additional surgery involving general or local anaesthetic. Risks associated with these techniques include graft or flap failure if the blood supply to the area is restricted, donor site complications, poor tissue matches, complications such as infection or blood loss requiring transfusion, pain and discomfort and scarring (NHS Choices).
Population, setting and intended user
The TopClosure TRS could be used in adults and children for treating traumatic wounds or for planned procedures, such as skin or soft tissue tumour excision.
The TopClosure TRS is currently designed to be used by appropriately trained surgeons in a secondary care, for post-operative wound healing.
Pre-operative skin stretching could be done in the home by the patient or a family member after appropriate training. It could also be done in an outpatient setting by a healthcare professional who has training in using the system.
TopClosure TRS should not be used in people with a known allergy to adhesives, over infected tissue, or where the skin is damaged or weakened. The manufacturer's website has a full list of contraindications and instructions for use.
Costs
Technology costs
The manufacturer currently does not have a UK distributor but has provided the expected retail prices shown in table 1. Costs for shipping or local taxes may vary. The average cost per treatment will vary depending on the size and type of wound.
Table 1 TopClosure TRS costs
|
Description |
Cost |
Additional information |
|
TopClosure TRS 1S (1 set in a pack) |
US$70 to US$90 |
£56.40 to £72.50 (currency conversion on 22 November 2016) |
|
TopClosure TRS 3S (3 sets in a pack) |
US$170 to US$190 |
£136.70 to £152.80 (currency conversion on 22 November 2016) |
Costs of standard care
Wound closure in the NHS is currently done by direct stitching or stapling, skin grafts or flaps, or internal tissue expanders if the wounds are large. The cost of these procedures varies according to patient need, with the choice of procedure and equipment (for example, the suturing kit) depending on factors such as type and anatomic location of the wound, thickness of the skin, degree of tension and the desired cosmetic result.
Resource consequences
An undated report on the NHS England Innovation Portal estimates using the TopClosure TRS after tumour excisions would save between £1,000 and £3,700 per patient, depending on wound size, compared with the cost of standard care. No information was given on how these cost savings were calculated and so the relevance of this information is not clear.
The TopClosure TRS is not currently used in the NHS.
The system impact of implementing TopClosure would be minimal, with only a short training period needed for use. Uptake may be slow because there is no UK supplier, but the technology can be bought directly from the manufacturer. Training is included as part of the cost and would generally be done through a workshop and practical training.
The cost of the technology may be offset by the overall savings from reducing the need for skin grafts, skin flaps, or internal tissue expanders. Overall, using the TopClosure TRS could reduce morbidity associated with current wound closure techniques. The might result in reduced surgery times, inpatient bed days and better outcomes for patients.