Foot infections, particularly moderate to severe cases, pose significant challenges in healthcare. Negative pressure wound therapy (NPWT) is a common treatment, and this study aimed to Compare Foot wound healing efficacy using different NPWT devices and techniques. This research investigated whether varying NPWT devices or the addition of irrigation impacted patient outcomes.
This 12-week prospective, randomized noninferiority trial involved ninety patients hospitalized with moderate to severe foot infections. Participants were selected based on specific criteria, including an Ankle-Brachial Index (ABI) greater than 0.5 or toe pressures above 30 PVR/mmHg, and being over 18 years of age. Exclusion criteria were put in place to ensure the study focused on a specific patient group, excluding those with active Charcot arthropathy, collagen vascular disease, HIV, or hypercoagulable states. The study rigorously compared foot wound treatments by randomizing patients to three groups: NPWT-K (using KCI, VAC Ulta), NPWT-C (using Cardinal, PRO), and NPWT-I (using Cardinal, PRO with saline irrigation). All therapies were administered at a continuous pressure of 125 mmHg. For the NPWT-I group, saline irrigation was delivered at a rate of 15 ml per hour.
The primary goal was to compare foot wound healing rates across the groups, specifically measuring the proportion of wounds healed within 12 weeks. Secondary outcomes included surgical wound closure rates, the number of surgeries required, length of hospital stay, and the time taken for complete wound healing. Data analysis involved comparing continuous variables using analysis of variance and dichotomous variables using chi-square tests, with a significance level set at 0.05.
The results indicated no statistically significant differences in any of the measured outcomes when comparing foot wound treatments with different NPWT approaches. The proportion of healed wounds was similar across NPWT-I (63.3%), NPWT-C (50.0%), and NPWT-K (46.7%) groups (p = 0.39). Similarly, surgical wound closure rates showed no significant variation (83.3%, 80.0%, 63.3%, p = 0.15). The number of surgeries (2.0 ± 0.49, 2.4 ± 0.77, 2.4 ± 0.68, p = 0.06), length of hospital stay (16.3 ± 15.7, 14.7 ± 7.4, 15.3 ± 10.5 days, p = 0.87), and time to wound healing (46.2 ± 22.8, 40.9 ± 18.8, 45.9 ± 28.3 days, p = 0.78) also showed no significant differences between the groups.
In conclusion, this study found that when comparing foot infection treatments using NPWT, there were no significant differences in clinical outcomes or adverse events among patients treated with different NPWT devices or NPWT with and without irrigation. This suggests that the choice of NPWT device or the addition of irrigation may not significantly impact treatment efficacy for moderate to severe infected foot wounds in hospitalized patients meeting the study criteria.
