1. In this randomized controlled trial, there was no difference in the self-reported disability 12 months after injury between patients treated with negative pressure wound therapy (NPWT) and those treated with standard wound dressings.
2. There was no difference in the number of patients with complete bone union 12 months after injury between the NPWT group and the standard dressing group.
Evidence Rating: 1 (Excellent)
Study Rundown: Open fractures are usually treated with surgical debridement and fixation, following which patients are often subject to routine local wound care either with standard dressings or NPWT. With the severity of these fractures, reduced quality of life is common and is unknown how different wound management strategies affect recovery. In this multicenter, randomized controlled trial, no differences were found in the mean self-reported disability at 3, 6, 9, or 12 months post between patients randomized to the NPWT or stand wound dressing groups. Additionally, there were no differences in the patients’ health-related quality of life. Finally, there were no difference found in the proportion of patients with complete bone union nor in the incidence of deep surgical site infections. While there were no significant differences between the two treatment groups, neither treatment group returned to their pre-injury (baseline) assessments in any domain.
This trial was well powered and well-designed, supporting the study’s final conclusions. Long-term follow up would be recommended in order to determine if there are any more subtle differences between the treatment groups over time. Considering the findings of this study, in addition to the cost differences between the two wound care methods, standard dressings are favored for lower extremity open fractures.
In-Depth [randomized controlled trial]: The Wound Management of Open Lower Limb Fractures (WOLLF) Trial randomized a total of 625 patients from July 2012 to December 1025. Ultimately, 460 patients were enrolled, 224 in the negative pressure would therapy (NPWT) arm and 234 in the standard treatment arm with 88% total follow-up. The primary outcome was patient-reported Disability Rating Index (DRI) at 12 months after randomization. Secondary outcomes were health-related quality of life using EuroQol 5-dimension, 3-level questionnaire (EQ-5D-3L), the Short Form-12 (SF-12), and deep surgical site infections at 30 days. Primary and secondary outcomes were evaluated on an intention-to-treat basis. Eligible patients were 16 years of age or older and had a severe open fracture of the lower extremity that, per the operating surgeon, could not be closed primarily. Excluded patients were those who presented to the hospital >72 hours after injury, had a contraindication to anesthesia, or who were unable to consent.
There was no difference in the DRI between patients treated with NPWT and those treated with standard wound dressings (Difference -3.9 points; CI95 -8.9 to 1.2 points). In addition, there was no significant differences in DRI at 3, 6, and 9 months post-injury (p > 0.05). There were also no differences in health-related quality of life measurements between the two treatment arms (p > 0.05). For the SF-12, the mean Physical Component Score at 12 months was 32.2 for the NPWT patients and 32.7 for the standard dressing patients (Difference 0.4; CI95 -0.3 to 3.8). The mean EQ-5D-3L score was 0.55 in the NPWT patients and 0.56 for the standard dressing patients (0.01; CI95 -0.06-0.07) in favor of standard dressings. Finally, out of 460 patients, 35 developed deep surgical site infections (7.6%), 16 (7.1%) the NPWT group and 19 (8.1%) in the standard dressing group (OR 0.85; CI95 0.42-1.70).
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