WOLLF Randomised Clinical Trial

Fractures of the lower limb are common injuries in civilian and military populations.

Most fractures are closed, meaning that the skin overlying the fracture is intact. Open fractures exist when the broken bone is exposed to contamination, resulting in a greatly increased risk of complications. In severe open fractures of the lower limb, infection rates up to 27% are reported, even in specialist trauma centers. The costs of treating wound complications is high for both patients and health care systems.

The initial management of open fractures involves surgical debridement with excision of damaged tissue, removal of contamination, and antibiotic administration. The fracture is usually immobilized with bone fixation and a dressing is applied to the surface of the wound. Traditionally, a sealed nonadhesive layer is applied to protect the open fracture from further contamination. Reassessment and further debridement of the wound are typically performed 48 to 72 hours later.

Negative pressure wound therapy (NPWT) is an alternative form of dressing. This device creates a partial vacuum using suction, which removes blood and fluid that may collect in the wound. The vacuum may also encourage the formation of granulation (healing) tissue.4,8 However, NPWT dressings and the vacuum machines are considerably more expensive than traditional wound dressings.

Before this study, there has been only one randomized clinical trial comparing standard wound dressing with NPWT for patients with open fractures of the lower limb.9 Improved outcomes were suggested in patients treated with NPWT but the study was not definitive because it included only 59 patients treated at a single trauma center. Despite the lack of strong evidence, clinical guidelines around the world have recommended the use of NPWT for open fracture wounds.

The aim of this pragmatic, multicenter randomized clinical trial was to compare standard wound dressings with NPWT for adults with an open fracture of the lower limb.