Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Six studies are summarised in this briefing, including a total of 96 people. The evidence includes 1 prospective observational study, 2 retrospective observational studies and 3 case studies.
The clinical evidence and its strengths and limitations are summarised in the overall assessment of the evidence.
Overall assessment of the evidence
The evidence base for fasciotens abdomen is limited and comes from non-comparative observational studies and case studies that involve a relatively small number of people. None of the included studies were done in the UK and results may not be generalisable to clinical practice in the NHS. The evidence suggests that the fasciotens devices may be a useful technique to aid abdominal wall closure. Further evidence from larger randomised comparative studies comparing fasciotens abdomen with standard care would be useful. Useful outcomes for further research include time to fascial closure, adverse events, length of stay, number of additional operations needed, and long-term follow up. Further studies should also evaluate which specific populations may benefit from the technology.
Niebuhr et al. (2020)
Study size, design and location
Prospective multicentre observational study of 21 people with complex hernias in Europe.
Key outcomes
Initial average fascial distance was 17.3 cm (range 8.5 to 44). After application of fasciotens abdomen, fascial distance decreased by 9.8 cm (range 1 to 26) to an average of 7.5 cm (range 2 to 19 [r=0.62]). The average increase of fascial length was 9.8 cm. All hernias were closed with moderate tension. In 19 patients, closure was reinforced by a mesh inserted with a sublay technique, and 2 closures were done with an intraperitoneal onlay mesh. The average immediate postoperative pain measured on a visual analogue scale was 2.5 (0 to 6). The average hospital stay was 14.5 days (range 6 to 75). Four patients had surgical site infections that were treated with a vacuum-assisted closure system.
Strengths and limitations
The main limitation of this study is the non-comparative design. Without a control, early fascial closure cannot be attributed to fasciotens abdomen. The study has a small sample size and was not done in the UK, so the results may not be generalisable to clinical practice in the NHS.
Niebuhr et al. (2021)
Study size, design and location
Retrospective multicentre study of 50 people with complex abdominal wall hernias in Europe.
Key outcomes
Initial fascial distances ranged from 8 cm to 44 cm. Most people (94%) had a fascial distance over 10 cm. Fascial distance was significantly reduced in all but 1 case. Mean fascial distance was reduced from 16.1 cm (standard error of the mean [SEM] 0.8) to 5.8 cm (SEM 0.7). The stretch gain was 10.2 cm (SEM 0.7; p<0.0001, Wilcoxon matched-pairs signed-ranks test). Direct closure was achieved in 45 cases (90%) and 41 people were treated with a mesh augmentation in a sublay position. Six people (12%) had postoperative complications and 3 people (6%) needed surgery again.
Fung et al. (2022)
Study size, design and location
Retrospective multicentre study of 20 people with an open abdomen in Germany.
Key outcomes
Initial average fascial distance was 15 cm (range 8 to 23) and the average duration of open abdomen was 3 days. At relook laparotomy 48 hours after application of fasciotens abdomen, the average fascial distance reduced to 10 cm (range 6 to 17; p=0.0081). Primary fascial closure was achieved without mesh or component separation in an average of 7 days (range 3 to 24). In 12 patients, fasciotens abdomen was applied with a negative pressure wound therapy system, and in 8 patients it was applied with an alternative temporary abdominal closure system. The average duration to primary fascial closure for patients with septic open abdomen was 7.5 days, and for non-septic open abdomen was 7 days. During follow up, 2 patients developed an incisional hernia.
Strengths and limitations
The main limitation of this study is the retrospective non-comparative design. Without a control, early fascial closure cannot be attributed to fasciotens abdomen. The study has a small sample size and was not done in the UK, so the results may not be generalisable to clinical practice in the NHS.
Bloemendaal (2022)
Study size, design and location
Case study of 3 people with complex hernias in the Netherlands.
Hees and Willeke (2020)
Study size, design and location
Case study of 1 person with an open abdomen caused by peritonitis in Germany.
Fung et al. (2019)
Study size, design and location
Case study of 1 person with an open abdomen caused by necrotising pancreatitis in Germany.
Recent and ongoing studies
Fasciotens to treat an open abdomen – a prospective cohort study. ClinicalTrials.gov identifier: NCT04033614. Status: recruiting. Indication: abdominal compartment syndrome, acute necrotising pancreatitis, intra-abdominal hypertension and peritonitis. Device: fasciotens abdomen. Estimated completion date: August 2026. Country: Germany.