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

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 ty...

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Bibliographic Details
Published in:World journal of surgery 2022-12, Vol.46 (12), p.2946-2953
Main 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
Format: Article
Language:English
Subjects:
Abdominal Surgery
Bandages
Cardiac Surgery
Diabetes mellitus
Electric power
Extremities
Female
Gauze
General Surgery
Granulation
Humans
Male
Medical dressings
Medicine
Medicine & Public Health
Middle Aged
Negative-Pressure Wound Therapy
Original Scientific Report
Pressure ulcers
Prospective Studies
Surgery
Surgical Wound Infection
Thoracic Surgery
Vascular Surgery
Wound Healing
Wounds
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Summary: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  
ISSN:0364-2313
1432-2323
DOI:10.1007/s00268-022-06713-8