SWHSI-2
Trial question
What is the effect of negative pressure wound therapy in patients with lower limb surgical wound healing by secondary intention?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 686
686 patients (170 female, 516 male).
Inclusion criteria: patients with a lower limb surgical wound healing by secondary intention.
Key exclusion criteria: malnutrition; life expectancy < 6 months; active systemic infection; chronic or non-surgical wounds; risk of bleeding or inadequate hemostasis; contraindications to negative pressure wound therapy; participation in an ongoing wound care trial.
Interventions
N=349 negative pressure wound therapy (negative pressure wound therapy applied to the wound in accordance with the manufacturer's guidance, application of 60-150 mmHg pressure).
N=337 usual care (routine wound care dressings without negative pressure wound therapy).
Primary outcome
Time to wound healing
187 days
195 days
195.0 days
146.3 days
97.5 days
48.8 days
0.0 days
Negative pressure wound
therapy
Usual
care
No significant
difference ↔
No significant difference in time to wound healing (187 days vs. 195 days; HR 1.08, 95% CI 0.88 to 1.32).
Secondary outcomes
No significant difference in hospital admission (19.7% vs. 18.1%; OR 1.13, 95% CI 0.76 to 1.69).
No significant difference in wound infection (31.9% vs. 31.2%; OR 1.05, 95% CI 0.75 to 1.48).
No significant difference in antibiotic use (65.9% vs. 65.6%; OR 1.01, 95% CI 0.7 to 1.45).
Safety outcomes
No significant differences in adverse events, serious adverse events.
Conclusion
In patients with a lower limb surgical wound healing by secondary intention, negative pressure wound therapy was not superior to usual care with respect to time to wound healing.
Reference
Catherine Arundel, Laura Mandefield, Caroline Fairhurst et al. Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial. Lancet. 2025 Apr 15:S0140-6736(25)00143-6. Online ahead of print.
Open reference URL