Validation of a Manual Negative Pressure Wound Therapy Device (PragmaVAC) for Acute and Chronic Wounds: A Prospective, Randomized, Controlled Trial.

Abstract

Negative pressure wound therapy (NPWT) is an alternative to the standard gauze dressings for wound treatment. Due to limited health resources, poor electrical supply, and high costs, NPWT in resource-constrained settings is inaccessible. In conflict-affected settings, civilian injuries typically involve traumatic wounds or chronic wound infections that affect the extremities. PragmaVAC^® is a manually operated NPWT device designed to increase accessibility to NPWT without the need of electrical power. We aimed to determine the clinical efficacy of PragmaVAC through a controlled, non-blinded open-label clinical trial in a resource-constrained locality. The endpoint was formation of granulation tissue sufficient for wound closure. Fifty-nine patients qualified for analysis (19 Gauze; 40 PragmaVAC). The mean age of participants was 49.25 years, 55.9% were male, and 42.4% were diabetic. Forty three wounds (72.9%) were acute, 44 wounds (74.6%) were clean-contaminated, and 34 wounds (57.6%) were localized to the lower limb. The average duration of treatment was 15.3 days in PragmaVAC vs 36.5 days in control, p = 0.013. Similarly, PragmaVAC required fewer number of dressing changes 2.7 vs 23.2 times, p < 0.0001, at a lower frequency of dressings 0.22/day vs 0.73/day, in the control group, p < 0.0001. PragmaVAC is associated with accelerated healing and less frequent requirement of dressing changes. The introduction of a manually operated, low-cost device in resource-constrained settings presents an opportunity to improve wound care outcomes, decrease interventions, and optimize usage of material and human resources.