Literature DB >> 36175648

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

Mahmoud Hariri1,2, Bakry Maaz3, Measser Netfagi4, Jude Alawa5, Ahmad Sattouf6, Hussam Alden Dubies7, Jehad Alahmad8,7, Muhammet Fuat Seyitisa9, Amandine Godier-Furnemont10, Abedalkarem Ghali3, Ahmad Ghandour4, Zohair Abdullah4, Munther Alsaleh3, Ibrahim Almousa7, Waiel Habib6, Hisham Alshaer9.   

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.
© 2022. The Author(s) under exclusive licence to Société Internationale de Chirurgie.

Entities:  

Year:  2022        PMID: 36175648     DOI: 10.1007/s00268-022-06713-8

Source DB:  PubMed          Journal:  World J Surg        ISSN: 0364-2313            Impact factor:   3.282


  12 in total

Review 1.  Evidence-based recommendations for the use of negative pressure wound therapy in chronic wounds: steps towards an international consensus.

Authors:  S Vig; C Dowsett; L Berg; C Caravaggi; P Rome; H Birke-Sorensen; A Bruhin; M Chariker; M Depoorter; R Dunn; F Duteille; F Ferreira; J M Francos Martínez; G Grudzien; D Hudson; S Ichioka; R Ingemansson; S Jeffery; E Krug; C Lee; M Malmsjo; N Runkel; R Martin; J Smith
Journal:  J Tissue Viability       Date:  2011-11-25       Impact factor: 2.932

2.  Comparing conventional gauze therapy to vacuum-assisted closure wound therapy: a prospective randomised trial.

Authors:  C M Mouës; G J C M van den Bemd; F Heule; S E R Hovius
Journal:  J Plast Reconstr Aesthet Surg       Date:  2006-06-22       Impact factor: 2.740

Review 3.  Evidence-based recommendations for the use of Negative Pressure Wound Therapy in traumatic wounds and reconstructive surgery: steps towards an international consensus.

Authors:  E Krug; L Berg; C Lee; D Hudson; H Birke-Sorensen; M Depoorter; R Dunn; S Jeffery; F Duteille; A Bruhin; C Caravaggi; M Chariker; C Dowsett; F Ferreira; J M Francos Martínez; G Grudzien; S Ichioka; R Ingemansson; M Malmsjo; P Rome; S Vig; N Runkel; R Martin; J Smith
Journal:  Injury       Date:  2011-02       Impact factor: 2.586

Review 4.  Managing wound pain in patients with vacuum-assisted closure devices.

Authors:  Diane L Krasner
Journal:  Ostomy Wound Manage       Date:  2002-05       Impact factor: 2.629

5.  Negative pressure-assisted endoscopic pilonidal sinus treatment.

Authors:  P Giordano; E Schembari; K Keshishian; C A Leo
Journal:  Tech Coloproctol       Date:  2021-03-23       Impact factor: 3.781

6.  Experience with wound VAC and delayed primary closure of contaminated soft tissue injuries in Iraq.

Authors:  Brian E Leininger; Todd E Rasmussen; David L Smith; Donald H Jenkins; Christopher Coppola
Journal:  J Trauma       Date:  2006-11

Review 7.  The economic benefits of negative pressure wound therapy in community-based wound care in the NHS.

Authors:  Caroline Dowsett; Lynn Davis; Valerie Henderson; Richard Searle
Journal:  Int Wound J       Date:  2012-02-09       Impact factor: 3.315

8.  Blocked randomization with randomly selected block sizes.

Authors:  Jimmy Efird
Journal:  Int J Environ Res Public Health       Date:  2010-12-23       Impact factor: 3.390

9.  Negative pressure wound therapy literature review of efficacy, cost effectiveness, and impact on patients' quality of life in chronic wound management and its implementation in the United kingdom.

Authors:  Diaa Othman
Journal:  Plast Surg Int       Date:  2012-05-30

10.  Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials.

Authors:  Yvonne Zens; Michael Barth; Heiner C Bucher; Katrin Dreck; Moritz Felsch; Wolfram Groß; Thomas Jaschinski; Heike Kölsch; Mandy Kromp; Inga Overesch; Stefan Sauerland; Sven Gregor
Journal:  Syst Rev       Date:  2020-10-10
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