Negative Pressure Wound Therapy (NPWT) is a well-established treatment for complex wounds, but how do different NPWT devices compare, and does irrigation enhance outcomes for infected foot wounds? This study rigorously examined these questions in patients hospitalized with moderate to severe foot infections.
This prospective, randomized, noninferiority trial spanned 12 weeks and involved ninety patients with infected foot wounds requiring NPWT post-surgery. The study focused on patients with adequate blood flow to the foot (ABI > 0.5 or toe pressures >30 PVR/mmHg) and excluded individuals with conditions known to impair wound healing, such as active Charcot arthropathy, collagen vascular disease, HIV, or hypercoagulable states. The core objective was to directly compare the effectiveness of three NPWT approaches:
- NPWT-K: Utilizing the KCI, VAC Ulta device, a traditional NPWT system.
- NPWT-C: Employing the Cardinal, PRO device, another standard NPWT system.
- NPWT-I: Using the Cardinal, PRO device with simultaneous saline irrigation at 15 ml per hour, exploring the benefits of irrigation alongside NPWT.
All NPWT treatments were consistently administered at a continuous pressure of 125 mmHg. The primary measure of success was the proportion of wounds healed within 12 weeks. Secondary outcomes provided a broader picture of treatment efficacy, including surgical wound closure rates, the number of surgeries needed, hospital length of stay, and the time taken for complete wound healing.
The results indicated no statistically significant differences across the three treatment groups in any measured outcome. Specifically, the proportion of healed wounds at 12 weeks was 63.3% for NPWT-I, 50.0% for NPWT-C, and 46.7% for NPWT-K (p = 0.39). Surgical wound closure rates were also comparable at 83.3%, 80.0%, and 63.3% respectively (p = 0.15). The average number of surgeries required was statistically similar across groups (NPWT-I: 2.0 ± 0.49, NPWT-C: 2.4 ± 0.77, NPWT-K: 2.4 ± 0.68, p = 0.06), as was the length of hospital stay (NPWT-I: 16.3 ± 15.7 days, NPWT-C: 14.7 ± 7.4 days, NPWT-K: 15.3 ± 10.5 days, p = 0.87) and the time to wound healing (NPWT-I: 46.2 ± 22.8 days, NPWT-C: 40.9 ± 18.8 days, NPWT-K: 45.9 ± 28.3 days, p = 0.78).
In conclusion, this study did not find any significant differences in clinical outcomes or adverse events among patients treated with different NPWT devices or between NPWT with and without saline irrigation for moderate to severe foot infections. This suggests that the choice of NPWT device or the addition of irrigation may not critically impact healing outcomes in this patient population, allowing clinicians to focus on other factors relevant to individual patient care and resource availability.
