The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.
Objective: This study aims to evaluate the benefits of treating diabetic foot ulcers (DFU) through a revised procedure using the mechanisms underlying negative pressure wound therapy (NPWT) in such a way as to achieve reduced and more evenly distributed lateral tension lines across the wound. Method: Patients with type 2 diabetes were assessed for elegibility. Included patients were divided randomly into two groups: the NPWT control group and the NPWT+ group. Patients in the NPWT control group were treated in the traditional manner: wounds were covered with foams shaped to fit the wound precisely. In the NPWT+ group, foams were shaped to fit the wound precisely, and an additional foam was then wrapped around the foot. Results: Some 85 patients were assessed for eligibility; 59 were randomised into two groups: 29 patients in the NPWT+ group and 30 patients in the NPWT group. The primary objective was median healing time (NPWT+ 19 days, interquartile ratio (IQR) 7.5; NPWT 33 days, IQR 16; p<0.00001), and complete wound healing at three weeks (NPWT+ 55.20% NPWT 26.70% p=0.02). Secondary endpoints included number of major amputations (none in either group) and number of infections (NPWT+ 3.44% of patients, NPWT 6.66% of patients; p=0.57). Conclusion: Our initial findings show that this treatment significantly reduced wound closure times and accelerated healing in DFUs. It also demonstrated promising improvements in healing rates, with no significant increase in wound complications.
Diabetic foot ulcer (DFU) is a diabetes complication which greatly impacts the patient’s quality of life, often leading to amputation of the affected limb unless there is a timely and adequate management of the patient. DFUs have a high economic impact for the national health system. Data have indeed shown that DFUs are a major cause of hospitalization for patients with diabetes. Based on that, DFUs represent a very important challenge for the national health system. Especially in developed countries diabetic patients are increasing at a very high rate and as expected, also the incidence of DFUs is increasing due to longevity of diabetic patients in the western population. Herein, the surgical approach focused on the targeted use of the acellular dermal matrix has been integrated with biochemical and morphological/histological analyses to obtain evidence-based information on the mechanisms underlying tissue regeneration. In this research report, the clinical results indicated decreased postoperative wound infection levels and a short healing time, with a sound regeneration of tissues. Here we demonstrate that the key biomarkers of wound healing process are activated at gene expression level and also synthesis of collagen I, collagen III and elastin is prompted and modulated within the 28-day period of observation. These analyses were run on five patients treated with Integra® sheet and five treated with the injectable matrix Integra® Flowable, for cavitary lesions. In fact, clinical evaluation of improved healing was, for the first time, supported by biochemical and histological analyses. For these reasons, the present work opens a new scenario in DFUs treatment and follow-up, laying the foundation for a tailored protocol towards complete healing in severe pathological conditions.
Our findings show that the device demonstrates advantages in the reduction of debridement times, and efficacy in safely preserving the viable tissue, with a low complication rate in surgery of DFUs. A study that uses a larger cohort is required to fully evaluate the effectiveness, or otherwise, of the ultrasonic debridement system.
The FWM seems ideal for tunneled and cavity ulcers with irregular geometry. This new porous matrix allows closure of the lesion while reducing healing time and demolition surgery.
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