Leukomed Sorbact for preventing surgical site infection

The relevant clinical evidence consists of 5 studies, including 3 randomised trials

3.1 The external assessment centre (EAC) considered 5 publications:

The EAC excluded 5 studies identified by the company because 4 did not include Leukomed Sorbact and there were significant uncertainties about the design of 1 study.

The evidence considered is limited to caesarean section and vascular surgery

3.2 Stanirowski et al. 2016a and 2016b were both done in Poland in women having elective or emergency caesarean section. Totty et al. 2019 and Bua et al. 2017 were UK studies in people having vascular surgery. *******************.

The evidence suggests Leukomed Sorbact reduces SSIs in caesarean section and vascular surgery

3.3 Up to 30 days after surgery, surgical site infection (SSI) rates were lower for people having Leukomed Sorbact compared with those having standard dressings. The difference in infection rates was not always statistically significant depending on the trial size. The largest RCT, considered to have the least risk of bias (Stanirowski et al. 2016a), reported a SSI rate of 1.8% for people having Leukomed Sorbact after caesarean section, and 5.2% for those having standard dressings at 14 days (statistically significant, p=0.04). Stanirowski et al. 2016b reported a SSI rate of 2.8% for people having Leukomed Sorbact after caesarean section, compared with 9.8% for those having standard dressings at 14 days (p=0.08). Bua et al. 2017 reported a SSI rate of 1% for Leukomed Sorbact and 10% for standard dressings at 5 to 7 days (statistically significant, p<0.05). Totty et al. 2018 and Bua et al. 2017 reported SSI rates of 16% and 9% at 30 days respectively for people having Leukomed Sorbact after vascular surgery, compared with 26% and 20% for standard dressings. The differences were not statistically significant (p=0.161 and p=0.83, respectively).

The evidence suggests that Leukomed Sorbact may reduce antibiotic use

3.4 In 3 studies there was less need for antibiotic treatment with Leukomed Sorbact compared with standard dressings (Bua et al. 2017, Stanirowski et al. 2016a and 2016b). In all studies the numbers reported as having antibiotics were low in both arms, and the reported differences were not statistically significant in Stanirowski et al. 2016a (0 in Leukomed Sorbact group, 4 in control group, p=0.13).

The evidence suggests that Leukomed Sorbact may reduce readmissions from wound complications

3.5 Stanirowski et al. 2016a reported that people with a SSI in the standard dressings group each had 2.9 outpatient hospital visits. People with a SSI in the Leukomed Sorbact group had 4.6 visits, a difference that was statistically significant, p=0.02. However, this was a secondary analysis in a small subgroup of patients. The same study found fewer additional days in hospital in people having Leukomed Sorbact (0 days compared with 8.2 days for standard dressings, p=0.22).

The published economic evidence suggests Leukomed Sorbact is cost saving

3.6 The economic analysis in the Stanirowski et al. 2016a and Stanirowski et al. 2019 studies showed that Leukomed Sorbact is cost saving when compared with standard surgical dressings. Stanirowski et al. 2016a reported total costs for preventing and treating SSIs of 5,775 euros in the standard care group compared with 1,065 euros in the Leukomed Sorbact group. Stanirowski et al. 2019 used the same data and applied a decision-analytic model from a UK NHS perspective. This showed a cost saving of £119.07 per patient in favour of Leukomed Sorbact.

The company's cost modelling finds Leukomed Sorbact to be cost saving for caesarean section, vascular surgery and all surgery

3.7 The company submitted a simple decision tree model with 2 interventions, Leukomed Sorbact or standard surgical dressings. There were 2 outcomes, SSI or no SSI. The time horizon was 30 days. The company reported base-case cost savings per person with Leukomed Sorbact of £107.43 for caesarean section, £23.55 for vascular surgery, and £20.56 for all surgery. The company's sensitivity analyses found these results to be robust to parameter changes.

The EAC agrees with the company's cost model but disagrees about including all surgery because of lack of evidence

3.8 The EAC agreed with the company's model and its assumptions and made 1 change, to the cost of an SSI episode for vascular surgery. Leukomed Sorbact remained cost saving but the cost savings were lower than those estimated by the company's model for vascular surgery, at £17.82 per patient. The cost savings remained robust to parameter changes. The EAC chose not to model the use of Leukomed Sorbact for all types of surgery because it considered that there was insufficient clinical evidence to do so.