Advice
The technology
The technology
The fasciotens abdomen and hernia (Fasciotens) devices are used for complex hernias or open abdomen treatment (laparostomy) in which the gut and other intraperitoneal organs are exposed. They use controlled vertical traction to aid abdominal wall closure. The company claims that the technology prevents retraction of the fascia and abdominal wall during open abdomen treatment and allows the surgeon to 'stretch' the abdominal wall in a controlled way.
The fasciotens devices consist of a stand and a suspended thread retainer that hangs over the abdomen during treatment. Six sutures tied to each fascial margin of the open wound are then fastened to the device's thread retainer at the same tension using fixing clips. The traction applied to the abdominal wall or fascia can be adjusted using a screw mechanism. The overall applied traction is displayed on a scale attached to the device and can be adjusted throughout treatment. The fasciotens abdomen device has 2 supporting feet that are placed on the chest and anterior pelvic ring during treatment. The fasciotens hernia device is screwed onto the fasciotens hernia carrier and can be attached to a bedside rail or table for stability.
Innovations
The company claims that the technology is the only device that brings quantifiable vertical tension to the abdominal wall and allows abdominal closure, reducing the need for mesh bridging or component separation. The company claims that it prevents fascial retraction, increases intra-abdominal volume, and preserves the integrity of the abdominal wall, enabling direct closure of complex hernias and the open abdomen.
Current care pathway
Management of the open abdomen after a laparostomy includes using dressings or impermeable devices, such as a Bogota bag or negative pressure wound therapy devices, to protect the exposed organs and limit fluid leakage. The abdomen may be left to heal by secondary intention or delayed closure may be done using sutures, mesh repair, skin grafts, muscle flaps or a combination of these. The choice of closure technique depends on the size of the wound and other clinical considerations. A clinical expert noted that leaving a wound to heal by secondary intention or delaying closure is associated with increased complications.
Complex hernias are typically treated by surgical repair using synthetic mesh. Botulinum toxin may be injected into the muscles around the hernia to increase elasticity. They can also be treated with component separation, a surgical technique in which the abdominal muscles are separated to increase cover of the abdominal wound. Using this technique often means healthy abdominal wall muscle is cut away. There is an increased risk of seroma, haematoma, infections, and a lateral bulging because of the muscles weakening.
The following publications have been identified as relevant to this care pathway:
-
NICE's medtech innovation briefing on cyanoacrylate glue for hernia mesh fixation
-
NICE's guideline on the diagnosis and management of abdominal aortic aneurysm
-
NICE's guideline on the assessment and initial management of major trauma
-
NICE's interventional procedures guidance on negative pressure wound therapy for the open abdomen.
Population, setting and intended user
Fasciotens is intended for use alongside standard care to aid abdominal wall closure in complex hernias or during open abdomen treatment. The company says that it can be used for kidney, liver, digestive tract and urological conditions, and for infections, injuries, accidents and wounds.
Fasciotens is likely to be used by colorectal, upper gastrointestinal and general surgeons in secondary care settings, such as operating theatres and intensive care units. The company offers training and support to healthcare professionals for the first time they use fasciotens, and other additional support as needed. The company says that training is typically in the clinical application of the device, set up, best practice and aftercare, and maintaining the device. The company also says that it has videos and user guides on its website.
Costs
Technology costs
Fasciotens abdomen costs £3,995.50 (excluding VAT) per device. Fasciotens hernia costs £1,760 and the hernia carrier is £3,650 (excluding VAT). Fasciotens abdomen and hernia are single use only and should be disposed of after use. The fasciotens hernia carrier is reusable. The company provides free training.
Resource consequences
Fasciotens hernia has been trialled in 8 hospitals across England and Scotland.
Fasciotens is intended to be used alongside standard care, so it initially costs more than standard care alone. The company claims that the technology could lead to cost savings by shortening length of stay in intensive care units and reducing the number of surgical revisions. There is no published evidence to support these claims. The company says that no changes to facilities or infrastructure are needed to adopt the technology.