Pooled Study-level Analysis of Randomized Controlled Trials Analyzing the Effect of Negative Pressure Wound Therapy With Irrigation vs Traditional Negative Pressure Wound Therapy on Diabetic Foot Outcomes

Arthur Tarricone, DPM, MPH; Andrew Crisologo, DPM; Amanda Killeen, DPM; Allen Gee, MS; Karla De La Mata, DPM; Michael Siah, MD; Orhan Oz, MD, PHD; Prakash Krishnan, MD; Lawrence A. Lavery, DPM, MPH

Disclosures

Wounds. 2023;35(4):66-70. 

In This Article

Abstract and Introduction

Abstract

Introduction: The benefits of NPWT-T for the diabetic foot have been established. The addition of regular periodic irrigation with broad-spectrum antiseptic solution has been shown to reduce bioburden and total bacterial colonies; however, debate remains as to the clinical effect on diabetic foot outcomes.

Objective: This study investigated the differences between NPWT-T and NPWT-I for treatment of the diabetic foot and the associated clinical outcomes.

Methods: PubMed, Medline/Embase, the Cochrane Library, and Web of Science were searched for relevant literature published between January 1, 2002, and March 1, 2022. Keywords included "Negative Pressure Wound Therapy" AND "Instillation" OR "Irrigation." Three studies with a total of 421 patients (NPWT-T [n = 223], NPWT-I [n = 198]) were included in the meta-analysis.

Results: No significant differences were observed between NPWT-T and NPWT-I for BWC (OR, 1.049; 95% CI, 0.709–1.552; P =.810), time to wound closure (SMD, −0.039; 95% CI, −0.233–0.154; P =.691), LOS (SMD, 0.065; 95% CI, −0.128–0.259; P =.508), or AEs (OR, 1.092; 95% CI, 0.714–1.670; P =.69).

Conclusion: Results of this systematic review and meta-analysis indicate that further RCTs are required to assess the role of NPWT-I in the management of DFU and DFI.

Introduction

DM is a growing epidemic that is increasing in both prevalence and incidence, with an estimated 8.5% of adults worldwide living with DM as of 2014.[1] DM is associated with multiple comorbidities and was directly responsible for more than 1.5 million deaths worldwide in 2019, with nearly 50% of these deaths occurring prematurely (before age 70 years).[1]

A severe sequela of DM is the development of DFU, which is attributed to a multitude of factors resulting from complications of diabetes, including neuropathy, peripheral vascular disease, compromised immune function, and muscle glycosylation leading to biomechanical deformities. Diabetes has historically been the greatest contributor to nontraumatic lower extremity amputations, and foot ulcers remain the primary reason for hospitalization.[2,3] A 2017 study estimated the global prevalence of DFUs to be 6.5%, with prevalence in the United States approximately twice that, at 13%.[4] DFUs lead to increased amputations, reduced quality of life, and enormous financial burden to both the individual and the community.[5] A major cause of this morbidity and mortality is the progression of DFU to DFI.[6,7] It has been estimated that over 80% of DFUs progress to DFI, posing a 56 to 155 times increased risk for lower extremity amputation.[5,8] SOC therapy for both DFU and DFI has traditionally consisted of a combination of sharp debridement, bacterial burden control, and offloading. NPWT has become a pivotal tool for improving health outcomes, demonstrating substantial benefit compared with SOC in BWC, time to wound closure, and reduction in amputations.[2,9]

The next generation of NPWT has included simultaneous irrigation with solution (NPWT-I) at predetermined settings. NPWT-I continues to show improved outcomes compared with SOC, with the added benefit of decreasing QBCs.[5,8,10–13] Despite the reduction in bacterial burden, debate persists regarding the clinical effect of NPWT-I on diabetic foot outcomes compared with NPWT-T. The authors of the current study investigated the differences in outcomes in patients treated with NPWT-T versus NPWT-I, specifically, BWC, time to wound closure, LOS, and AEs.

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