Advice
Expert comments
Expert comments
Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.
Four experts commented on this briefing. Three out of 4 experts had knowledge of or had used this technology before.
Level of innovation
All 4 experts agreed that fasciotens is a novel technology and has the potential to improve patient outcomes. Two experts felt that fasciotens is the first in a new class of procedure. Two experts said that a similar technique using medial tension is used outside the UK but noted that this is less controlled and tension is applied to sutures one at a time. One expert said that fascial tension devices are being added to the British Hernia Society Registry because it feels that more devices using a similar concept will continue to be developed.
Three experts said that fasciotens would be used alongside current standard care to complement current techniques and aid patient recovery. One expert said that it could be particularly helpful in closing open abdomens that have not closed within 48 hours because of fascial retraction or concerns about component separation. They also noted that it would need to be used alongside negative pressure wound therapy for open abdomen treatment to manage fluid secretion and prevent adhesions. One expert felt that fasciotens could replace current standard care techniques such as synthetic mesh and component separation.
Potential patient impact
Experts agreed that fasciotens has the potential to aid earlier closure of open abdominal wounds, which could lead to less pain, shorter hospital stays, and improved long-term outcomes for patients. Two experts said that patients may also benefit from reduced use of prosthetic materials, such as mesh, minimising foreign materials in the body. Experts agreed that patients having open abdomen treatment after various conditions and people with large hernias may benefit from this technology. One expert specified that most abdominal wounds will be closed during a first revisit to theatre and said that the technology would be used for patients with persistent retraction of the abdominal wall. Two experts said that there may be a risk of pressure sores from the feet of the fasciotens abdomen device, or excess stretching of the abdominal wall, which could cause tearing and weakness. Two experts said that there is a risk of increased abdominal pressure and hernia recurrence, but 1 noted that the data reports fewer risks than current wound closure techniques.
Potential system impact
All 4 experts said that fasciotens has the potential for cost savings compared with standard care. That is, if it reduces the length of stay, the number of surgical revisions and use of other resources, such as negative pressure wound equipment or prosthetic materials. One expert felt that there would be more cost savings if fasciotens was used in high-risk open abdomens and larger hernias. Three experts agreed that surgical staff would need to be trained, but 2 experts noted that the technology is easy to use, and that training would be minimal. One expert said that training would consist of observing 2 cases and performing 2 to 3 cases with supervision. One expert felt that there may be an increase in costs to sterilise the fasciotens hernia carrier but noted that standard hospital processes would be used to do this. All experts agreed that fasciotens could be used at most district general hospitals. Three experts said that they may use 5 to 10 fasciotens devices per year, but noted that this is in a district general hospital, and the number for tertiary centres may be up to twice this amount. One expert noted that they perform more complex abdominal wall reconstruction surgeries so would use more fasciotens hernia devices than fasciotens abdomen devices at their centre.
General comments
One expert commented that fasciotens can be difficult to put together initially because it requires a number of steps to assemble. But they noted that training videos and support from the company are available to guide clinicians. Three experts agreed that multicentre (potentially international) randomised trials are needed to confirm the potential benefits because the number of eligible patients per centre is low. One expert said that data on the costs of using fasciotens abdomen for open abdomen treatment in different populations is needed to see if there is a difference in potential benefits between groups. Experts noted that potential useful outcomes from future research include length of stay, use of synthetic mesh, incidence of incisional hernia after abdominal wall closure, subsequent surgeries and quality of life.