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

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A Correction to this article was published on 18 October 2022

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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.

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Acknowledgements

This project is supported by Creating Hope in Conflict: A Humanitarian Grand Challenge; a partnership of USAID, The UK Government, the Ministry of Foreign Affairs of the Netherlands, and Global Affairs Canada, with support from Grand Challenges Canada. Investigators would like to thank the members of the clinical trial steering committee members: Drs, Hani Mowafi, Department of Emergency Medicine, Yale School of Medicine, Yale University, New Haven, CT, USA; Thomas G Weiser, Associate Professor, Department of Surgery, Stanford University, USA; Doruk Ozgediz, Professor of Surgery Division of Pediatric Surgery, University of California, San Francisco, USA; Tariq Noman, Professor of Surgery, Althora Hospital, Taiz, Yemen; Aula Abbara, Infectious Diseases Consultant/ Senior Clinical Lecturer—Imperial College, London, UK. The authors would like to thank the Union of Medical Care and Relief Organizations (UOSSM), Gaziantep, Turkey, for their support in hiring the research nurses and dispensing the medical supplies.

Funding

This project is supported by Creating Hope in Conflict: a Humanitarian Grand Challenge; a partnership of USAID, The UK Government, the Ministry of Foreign Affairs of the Netherlands, and Global Affairs Canada, with support from Grand Challenges Canada.

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Authors and Affiliations

  1. Pragmatic Innovation Inc., Mississauga-Toronto, ON, Canada

    Mahmoud Hariri, Muhammet Fuat Seyitisa & Hisham Alshaer

  2. Syrian Board of Medical Specialties (SBOMS), Gaziantep, Turkey

    Mahmoud Hariri & Jehad Alahmad

  3. Mohamed Waseem Maaz Hospital, Northern Aleppo, Syria

    Bakry Maaz, Abedalkarem Ghali & Munther Alsaleh

  4. Rahma Darkoush Hospital, Darkoush, Syria

    Measser Netfagi, Ahmad Ghandour & Zohair Abdullah

  5. Stanford University School of Medicine, Stanford, CA, USA

    Jude Alawa

  6. Idleb Surgical Hospital, Idleb, Syria

    Hussam Alden Dubies, Jehad Alahmad & Ibrahim Almousa

  7. Department of Surgery, University of California San Francisco, San Francisco, CA, USA

    Amandine Godier-Furnemont

  8. Idleb Central Hospital, Idleb, Syria

    Ahmad Sattouf & Waiel Habib

Authors
  1. Mahmoud Hariri
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  2. Bakry Maaz
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Corresponding author

Correspondence to Mahmoud Hariri.

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Conflict of interest

Hariri, Alshaer, and Seyitisa receive financial compensation from Pragmatic Innovation Inc., the manufacturer of PragmaVAC devices used in this clinical trial, and have financial interest in its sales. Alshaer is the inventor and the owner of all intellectual property of PragmaVAC. All the other authors declare no conflicts of interest associated with this study.

Informed consent

Informed consent was obtained from all participants included in the study, including consent for image capture.

Ethical approval

This study was reviewed and received approval from the Veritas Ethics Review Board, Montreal, Canada, on December 4, 2020 (ID# 2020–2377-3537–3).

Trial registration number for randomized clinical trials

Trial NL9751 under title: Validation of Manual Negative Pressure Wound Therapy for Open Wounds, in Netherlands Trial Registry.

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The original online version of this article was revised: Measser Netfagi's family name was corrected.

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Hariri, M., Maaz, B., Netfagi, M. et al. Validation of a Manual Negative Pressure Wound Therapy Device (PragmaVAC) for Acute and Chronic Wounds: A Prospective, Randomized, Controlled Trial. World J Surg 46, 2946–2953 (2022). https://doi.org/10.1007/s00268-022-06713-8

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