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- Title
Validation of a Manual Negative Pressure Wound Therapy Device (PragmaVAC) for Acute and Chronic Wounds: A Prospective, Randomized, Controlled Trial.
- Authors
Hariri, Mahmoud; Maaz, Bakry; Netfagi, Measser; Alawa, Jude; Sattouf, Ahmad; Dubies, Hussam Alden; Alahmad, Jehad; Seyitisa, Muhammet Fuat; Godier-Furnemont, Amandine; Ghali, Abedalkarem; Ghandour, Ahmad; Abdullah, Zohair; Alsaleh, Munther; Almousa, Ibrahim; Habib, Waiel; Alshaer, Hisham
- 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.
- Subjects
NEGATIVE-pressure wound therapy; CHRONIC wounds &; injuries; WOUND care; TISSUE wounds; GRANULATION tissue; WOUND infections
- Publication
World Journal of Surgery, 2022, Vol 46, Issue 12, p2946
- ISSN
0364-2313
- Publication type
Article
- DOI
10.1007/s00268-022-06713-8