TopClosure Tension Relief System for wound closure

Level of innovation

All 3 specialist commentators stated that similar technologies are available and have been used in the NHS. Two commentators noted that the TopClosure TRS's method of attachment, using a combination of adhesives, staples and stitches to attach a tension band, was novel.

The commentators agreed that training would be needed to use the TopClosure TRS, and 2 of them thought that this would be minimal.

Potential patient impact

Two of the specialist commentators agreed that the technology could benefit patients because it offers a less invasive skin closure method. The third specialist noted that there is not enough available evidence to show any patient benefits, but it could benefit certain groups.

The specialists all identified people needing skin flaps for wound closure as a group which could benefit. One specialist also noted potential benefits for people having surgery for burns, skin and soft tissue tumours, or injuries, and people with peripheral arterial disease or diabetes who have ischaemia or infection. Other smaller groups who could benefit are those having pilonidal sinus excisions and people with wounds at high risk of breakdown, such as groin wounds in people who are obese. Using the TopClosure TRS has the potential to reduce skin donor site morbidity, the number of procedures needed, the number of hospital visits and morbidity and recovery time for patients.

The manufacturer claims that the TopClosure TRS could be used to treat hypertrophic or keloid scars but 1 specialist commentator felt that this use would not be appropriate.

One commentator identified a lack of evidence on pain or whether the technology caused dermal tears or stretch marks, both of which might be important considerations for the patient. Another commentator felt that attachment by staples would create further damage and possible scarring and so should be recognised as an aesthetic drawback.

Potential system impact

The specialist commentators agreed that the technology has the potential to reduce inpatient stay because it might allow some procedures to be done as day cases. One commentator noted that the TopClosure TRS needs to be removed at a further visit. Removal of the TopClosure TRS could be done in an outpatient setting, but more complicated procedures may need to be done in hospital, depending on the nature of the wound.

The commentators disagreed about the potential system impact of the TopClosure TRS. One noted that using the TopClosure TRS might make more invasive, inconvenient and expensive treatments for hard to heal wounds unnecessary, such as negative pressure wound therapy. Another felt that using this technology has the potential to increase the length of surgery and operating theatre use. The third commented that it may increase or decrease the length of surgery, depending on the alternative options for closure available for the person, but may reduce the duration of outpatient follow-up.

There were no anticipated changes to hospital infrastructure, but 1 commentator highlighted the need for hospital to keep stocks of the technology because it could be difficult to predict when it would be needed. This might increase costs if not used because the technology has a shelf-life.

All 3 commentators felt that the device had the potential to generate cost savings for the NHS, with 1 noting that the overall cost would depend on how often it was used.

General comments

One commentator noted uncertainty around management, specifically treating the wound and whether the TopClosure TRS should be removed or adjusted, if it became infected.

All the commentators raised concerns about the lack of comparative evidence available for this technology and that all available evidence was at risk of bias because the developer was involved in the included studies.

Specific concerns were highlighted about claims that the TopClosure TRS is suitable for wound closure over open fractures because there is a lack of evidence on the rate of wound breakdown and osteomyelitis, which would be serious because wound breakdown is associated with limb amputation at a later stage. One commentator also noted the lack of updated information in trial registers about ongoing studies involving the TopClosure TRS and questioned whether this might show a failure to recruit patients to trials or a failure to report negative results.