A study of a canister-based, single-use negative pressure wound therapy system in low-to-moderately exuding wounds.

OBJECTIVE

This study was conducted to evaluate the performance and safety of a canister-based, single-use negative pressure wound therapy (NPWT) system on patients with low-to-moderately exuding acute (traumatic wounds, flaps and grafts) and subacute (dehisced) wounds.

METHOD: This prospective, open, non-comparative multicentre study was conducted with both in- and outpatients. The primary performance measure was wound progress over time, evaluated weekly over four weeks. Secondary performance measures included: change in wound area and volume; change in tissue type and periwound skin condition; graft take and flap survival; exudate; pain; and participant and provider satisfaction. Safety data were also recorded.

RESULTS

A total of 112 participants were included in the study, conducted at 10 sites in four European countries. Wound progress was rated as improved at 80.7% (95% confidence interval: 75.0%, 85.6%) of visits, relative to the previous visit. Wound area decreased by a mean of 43.6% compared to baseline, with a corresponding mean decrease in wound volume of 61.5%. The proportion of participants with no necrotic or sloughy tissue and healthy periwound skin also increased over the study period, compared to baseline. Pain at dressing change was rated as low throughout the study, with high patient and clinician satisfaction scores recorded. No unexpected safety concerns were raised.

CONCLUSION

In this study, the canister-based, single-use NPWT system supported the healing of acute and subacute wounds over the study period.