Summary
A randomised trial in people with diabetes and noninfected wounds eligible for negative pressure wound therapy. It compares copper oxide dressings with a negative pressure treatment pathway, measuring wound size and other care outcomes.
- Study type
- Randomised clinical trial
- Study size
- 46 patients with diabetes randomised (23 per group); 38 completed (22 copper, 16 negative pressure); one hospital in Israel
Recruitment stopped early after an interim analysis showed the non-inferiority target had been met. Authors include MEDCu Technologies staff.
Key findings
- Copper dressings were non-inferior to negative pressure wound therapy for reduction in wound size (p<0.01).
- Wounds closed in 47.83% (11/23) of the copper group and 34.78% (8/23) of the negative pressure group; this difference was not statistically significant.
- Adjusted average time to wound closure was similar in both groups.
- More patients left the negative pressure group than the copper group (7 vs 1); an analysis accounting for this favoured copper dressings for wound-size reduction (p=0.03).
- Patients (p<0.001) and caregivers (p=0.003) rated copper dressings more convenient, and application time was shorter (p<0.001).
- Estimated copper dressing cost was 14% of negative pressure cost ($470 vs $3,360).