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. 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
There are more than 20 published studies on the Prevena device; this briefing summarises 7 studies that were considered to be the most relevant evidence to the NHS.
Six studies report outcomes for 596 people and 1 study for 119 incisions. One study was done in the UK and Ireland, 3 studies were done in Europe (Germany and Italy), 2 studies were done in the US and 1 in Canada.
The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.
Overall assessment of the evidence
The included studies are of good quality and compare Prevena with controls that are similar to NHS standard care for incision management, although only 1 study was done in the UK. The study designs comprise 2 randomised controlled trials, 2 prospective randomised studies, 1 prospective controlled study, 1 clinical feasibility study and 1 retrospective review. The studies included people recovering from a range of surgeries with incisions at different sites, such as groin incisions, femoral incisions, cardiac surgery, vascular surgery, breast cancer surgery, laparotomy and caesarean incisions. The studies included incisions that are considered difficult to heal such as bilateral groin incisions and caesarean incisions in people with obesity. The studies show that Prevena can lead to significantly reduced incision site complications in comparison with standard care dressings.
Pleger et al. (2017)
Study size, design and location
Study of 100 people with groin incisions in a prospective randomised study in Germany.
Intervention and comparator
Prevena versus standard care (adhesive plaster). Prevena or standard care were applied postoperatively, Prevena was removed after 5 to 7 days. All wounds were evaluated 5 to 7 days and 30 days postoperatively using Szilagyi classification.
Key outcomes
Wound healing complications were statistically significantly lower in the Prevena group compared with standard care (p=0.0011).
There were 5 wound healing complications (4 grade 1 and 1 grade 2) recorded at 30 day follow-up.
Revisions surgeries were statistically significantly lower in the Prevena group (1) compared with standard care (10) (p=0.012).
Strengths and limitations
People included in the study all had at least 1 risk factor for wound complications (age over 50 years, diabetes mellitus, renal insufficiency, malnutrition, obesity or chronic obstructive pulmonary disease).
The company provided medical writing and editorial assistance to the authors (no financial or scientific involvement or support).
Kwon et al. (2017)
Study size, design and location
Study of 119 femoral incisions in a prospective randomised study in the US.
Intervention and comparator
Prevena versus standard care (gauze), control group split into high-risk and low-risk (for wound complications) subgroups.
Key outcomes
Major wound complications were statistically significantly lower in the Prevena group (p<0.001) compared with high-risk standard care; as was reoperation (p<0.05), and readmission (p<0.04).
There was no difference in length of stay between the 2 groups.
There was an average cost saving of $6,045 per patient in the Prevena group compared with standard care for high-risk patients.
Strengths and limitations
Complications rates, length of stay, reoperation and readmission rates were all lower in low-risk controls. The authors conclude Prevena should be used in people at high risk for groin wound complications such as those who have BMI over 30, pannus, reoperation, prosthetic graft, poor nutrition, immunosuppression, or poorly controlled diabetes.
The results of this study are presented as an abstract only. The authors state that there were no statistically significant differences in baseline population characteristics but no further information is provided.
Lee et al. (2016)
Key outcomes
Use of Prevena was safe and well tolerated. Out of 33 Prevena systems, 3 were removed, 1 because of contact dermatitis and 2 because of a malfunctioning pressure alarm.
Length of post-operative stay was statistically significantly lower in the Prevena group compared with standard care (6 versus 10 days, p=0.008).
Strengths and limitations
The study reported no statistically significant differences in infections or complications between the 2 groups, however, it was not adequately powered to detect any difference and the authors state that the infection rate at the institution was very low (1.9%).
The study was funded by the company.
Engelhardt et al. (2018)
Study size, design and location
Randomised controlled trial of 132 people recovering from vascular surgery in Germany.
Intervention and comparator
Prevena versus standard care (absorbent dressing).
Prevena or standard care were applied postoperatively, Prevena was removed after 5 days. All wounds were evaluated at 5 days and 42 days postoperatively using Szilagyi classification.
Ferrando et al. (2018)
Study size, design and location
Prospective controlled study 37 people recovering from breast cancer surgery in Italy.
Intervention and comparator
Prevena versus standard care (Steri-strip skin adhesive closure).
Prevena was removed after 7 days.
Key outcomes
People in the Prevena group had a statistically significantly higher number of risk factors for wound complications compared with those in the standard care group (p=0.04).
Complication rate was statistically significantly lower in the Prevena group compared with standard care (4% versus 45%, p=0.001).
Strengths and limitations
People included in the Prevena group were expected to have poorer outcomes than those in the standard care group. Despite this, there were fewer complications recorded in the Prevena group.
Patients were followed up 1 year after surgery; there were no differences in scar appearance suggesting total healing had happened.
Study size, design and location
Retrospective review 181 people recovering from laparotomy in the UK and Ireland.
Intervention and comparator
Prevena versus retrospective review of standard care (adherent gauze).
Prevena was removed after 7 days.
Key outcomes
Complication rate was statistically significantly lower in the Prevena group compared with retrospective standard care (2.9% versus 20.5%, p=0.0009).
Strengths and limitations
Study design (retrospective review) introduces bias because Prevena group were treated under study conditions. The authors state that there were no statistically significant differences in baseline population characteristics between the 2 groups.
The company provided editorial assistance to the authors.
Gunatilake et al (2017)
Study size, design and location
Randomised controlled trial of 82 people with obesity recovering from caesarean section in the US.
Intervention and comparator
Prevena versus standard care (Steri-strips, sterile gauze and Tegaderm).
Prevena was removed after 5 to 7 days.
Key outcomes
Complication rate was lower in the Prevena group compared with standard care but the difference was not statistically significant (5.1% versus 16.3%, p=0.16).
Use of opioids (to treat incision pain) was statistically signicantly lower in the Prevena group compared with standard care (30% decrease, p=0.036).
Recent and ongoing studies
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A phase III randomised controlled trial of negative pressure wound therapy in post-operative incision management. ClinicalTrials.gov identifier: NCT02682316. Status: recruiting. Primary comparator: usual standard dry gauze used for wound management. Expected enrolment: 686. Estimated study completion date: February 2024. Location: United States.
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Wound healing after dirty/contaminated emergency abdominal surgery: Prevena™ incision management system vs conventional management. ClinicalTrials.gov identifier: NCT02892435. Primary comparator: standard dressing. Expected enrolment: 120. Estimated study completion date: December 2017. Location: Italy.