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Background: Diabetic foot ulcers are chronic, difficult to heal, and potentially life-threatening. Few medical devices have been studied in diabetic ulcers penetrating to bone or tendon. Methods: We conducted an international, open-label randomized controlled trial, randomly assigning patients with diabetic ulcers penetrating to bone, joint, or tendon 1:1 to intact fish skin graft or standard wound care, with assigned treatment applied through 14 weeks. The primary end point was the proportion of ulcers healed at 16 weeks, defined as reepithelization as identified by the investigator, and confirmed 14 days later. A blinded adjudication committee confirmed healing at both time points. Healing was also assessed at 20 and 24 weeks. Results: Between July 2020 and November 2022, 255 patients were randomly assigned to intact fish skin graft (n=129) or standard of care (n=126). Healing was achieved in 44% of patients at 16 weeks with intact fish skin graft compared with 26% for standard of care (P<0.001, unadjusted), with additional healing at 20 weeks (46% vs. 32%) and 24 weeks (55% vs. 38%). Mean (SD) time to healing was 17.3 (0.69) weeks (95% confidence interval [CI], 15.5 to 18.7) for the intact fish skin graft group and 19.4 (0.66) weeks (95% CI, 18.1 to 20.7) for the standard of care group. In a Cox regression, intact fish skin graft was associated with faster time to healing (hazard ratio, 1.59; 95% CI, 1.07 to 2.36). Primary wound infections were the most common adverse event, occurring in 39 (30.2%) of patients in the intact fish skin graft group and 31 (24.6%) of patients in the standard of care group. Conclusions: Among patients with deep diabetic foot ulcers, treatment with intact fish skin graft was superior to standard of care in proportion of wounds healed at 16 weeks and was associated with faster time to healing. (Funded by European Commission Fast Track to Innovation Horizon 2020, and Kerecis Ltd. ClinicalTrials.gov NCT04257370.) [ABSTRACT FROM AUTHOR]

Background: Diabetic foot ulcers not only have a negative impact on patient mortality, morbidity and quality of life, but also require high resource utilization to achieve complete wound healing. The aim of this evaluation was to compare resource utilization of negative pressure wound therapy (NPWT) and standard moist wound care (SMWC) for diabetic foot wounds after amputation, surgical debridement or wound cleansing. Methods: The multicenter clinical DiaFu study enrolled 368 adults with diabetic foot ulcers between December 23, 2011 and October 21, 2014. Patients were randomly assigned to NPWT and SMWC. Evaluation of direct resource use comprised inpatient and outpatient treatment time, and personnel and material for wound treatment within 16 weeks. This resource use analysis was primarily based on the per protocol population (NPWT 44; SMWC 110). Results: Treatment duration was 16 days shorter with NPWT (mean (SD) 82.8 (31.6), SMWC 98.8 (24.6); U test, p = 0.001) with 14.9 days shorter outpatient treatment (mean (SD) NPWT 68.3 (31.1), SMWC 83.2 (29.7)). The number of dressing changes per study participant was lower with NPWT (mean (SD) 35.1 (18.6), SMWC (42.9 (21.4); U test, p = 0.067). Time per dressing change was significantly lower with SMWC (mean (SD) 19.7 (12.8), NPWT (16.5 (8.2) minutes; U test, p < < 0.0001). Time for surgical debridements per study participant was 23.3 minutes shorter with NPWT (mean (SD) 20.5 (20.5), SMWC (43.8 (46.7); U test, p = 0.395). Conclusions: Resource use was lower for NPWT, which may be an efficient treatment alternative to SMWC for diabetic foot wounds, to be demonstrated in subsequent cost analyses. Trial registration: clinicaltrials.govNCT01480362 on November 28, 2011 [ABSTRACT FROM AUTHOR]

A group of international experts met in May 2006 to develop clinical guidelines on the practical application of vacuum assisted closure™ (V.A.C.®) † therapy in deep sternal wound infections. Group discussion and an anonymous interactive voting system were used to develop content. The recommendations are based on current evidence or, where this was not available, the majority consensus of the international group. The principles of treatment for deep sternal wound infections include early recognition and treatment of infection. V.A.C. therapy should be instigated early, following thorough wound irrigation and surgical debridement. V.A.C. therapy in deep sternal wound infections requires specialist surgical supervision and should only be undertaken by clinicians with adequate experience and training in the use of the technique. [ABSTRACT FROM AUTHOR]

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Rinsing wounds with wound cleansing solutions has long been a recognised cornerstone in wound management as a means of removing cell debris and surface pathogens in wound exudates. In combination with surgical debridement and topical negative pressure wound therapy (NPWT), this can facilitate the intended progression from the inflammatory to the proliferative phase of wound healing. Procedures of topical negative pressure wound therapy with instillation and a defined exposure/dwell-time of topical solutions under cyclic compression and decompression with foam dressings (NPWTi-d) can remove cellular remnants and debris that may inhibit the healing process. At the same time, it can aid in reducing the bacterial load in contaminated or infected wounds. Since this newer technique is now commercially available and increasingly widespread, recommendations for the proper use and clinical indications were developed by a panel of interdisciplinary experts in the course of a consensus meeting. Although the level of evidence from expert opinions is low, general guidelines for a safe and effective use of NPWTi-d can be worked out that can be of assistance to the clinician. The consensus recommendations derived from this meeting include the objectives of the treatment, the administration modalities of NPWTi-d, the indications for various wounds, including their contraindications, therapy settings, as well as the use of topical instillation solutions, volume and duration (dwell time) based on current scientific data, optimal treatment duration and future developments of the NPWTi-d., Competing Interests: Der Expertenkonsensus wurde von der Firma KCI-Acelity gesponsert; die Mitglieder der Expertengruppe waren in der Vergangenheit als Referenten oder wissenschaftliche Experten für KCI-Acelity tätig., (Georg Thieme Verlag KG Stuttgart · New York.)