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

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.