Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT.

OBJECTIVES: The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice. DESIGN: In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool. SETTING: This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care. PARTICIPANTS: 368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included. INTERVENTIONS: NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months. RESULTS: In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI-4.7% - 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT. CONCLUSIONS: NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure. TRIAL REGISTRATION NUMBERS: NCT01480362 and DRKS00003347.

[Use of Negative Pressure Wound Therapy with Instillation and Dwell Time for Wound Treatment - Results of an Expert Consensus Conference]. / Einsatz der Vakuuminstillationstherapie für die Wundbehandlung ­ Ergebnis einer Expertenkonsensuskonferenz.

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.

Long-term outcome after Talent endograft implantation for aneurysms of the abdominal aorta: a multicenter retrospective study.

BACKGROUND: The development of newer-generation endografts for the endovascular treatment of abdominal aortic aneurysms has resulted in considerable improvements in clinical performance. However, long-term outcome data are still scarce. To assess long-term clinical and radiographic outcomes after use of the Talent stent graft, a retrospective analysis was performed that was based on 165 patients treated with this endograft in Germany between October 1996 and December 1998. METHODS: Data were collected according to the recommendation of the ad hoc committee for standardized reporting practices in vascular surgery and were evaluated statistically by using univariate and multivariate analyses. RESULTS: A total of 165 patients were treated with a Talent endograft in 9 German centers before December 31, 1998. Most were asymptomatic (94.5%), male (97.6%), and treated with a bifurcated graft (86.7%). Two patients (1.2%) died within 30 days, and 28 (17%) died during the follow-up period. The cause of death was aneurysm rupture in one case. Survival was 95.4% +/- 1.7% at 1 year, 89% +/- 2.6% at 2 years, 78.1% +/- 3.6% at 5 years, and 76.2% +/- 4.1% at 7 years. Patients classified as American Society of Anesthesiologists grade IV had a significantly lower survival rate (24.9%) than those classified as American Society of Anesthesiologists grade II and III (91.9% and 77.3%). During a mean follow-up period of 53.2 +/- 20.1 months (range, 1-84 months), 47 secondary procedures were performed in 31 patients (18.8%). Kaplan-Meier estimates showed a freedom from secondary intervention of 94.7% +/- 1.8%, 81.7% +/- 3.3%, and 77.4% +/- 3.6% at 1, 3, and 7 years, respectively. The reason for secondary treatment was endograft thrombosis in 10 patients (6.1%), persisting primary endoleak in 9 (5.5%), late secondary endoleak in 6 (3.6%), graft migration in 3 (1.8%), aneurysm rupture in 2 (1.2%), and graft infection in 1 (0.6%). Device migration (> or =10 mm) occurred in seven patients (4.2%). Other graft changes, such as graft kinking (n = 4; 2.4%), fracture of metallic stents (n = 2; 1.2%), erosion of the longitudinal bar (n = 2; 1.2%), or modular component separation (n = 1; 0.6%), were rare. Follow-up computed tomographic imaging revealed a decrease of the maximum aneurysm sac diameter (>5 mm) in 106 (64.2%) patients and an increase in 14 (8.5%) patients. The mean aneurysm diameter significantly decreased (P < .001). Of the factors recorded at baseline, only endoleaks showed a significant correlation with the risk of aneurysm increase during follow-up (P < .001). Adverse anatomy (neck diameter >28 mm, neck length <15 mm, and '5 patent aortic branches) did not adversely influence the aneurysm shrinkage rate, the risk for a secondary procedure, or the clinical success rate. A significantly higher rate of clinical success (P < .05) was observed in patients older than 65 years of age. CONCLUSIONS: Implantation of the Talent endograft device is a safe and effective alternative to open surgery for exclusion of abdominal aortic aneurysm. In comparison with first-generation grafts, the device showed superior durability for as long as 5 to 7 years after implantation. Even if prototypes of the Talent device were implanted in this study, the graft was also successfully used in most patients, even in those with adverse anatomy. Because improvements of the endograft have been made to address connecting bar breaks, a lower incidence of graft limb occlusion can be expected in the future.

Fibrin sealants in supporting surgical techniques: The importance of individual components.

Fibrin sealants have many different uses across a broad range of surgeries, where they have proved successful in controlling bleeding, providing suture support and tissue sealing. The action of all fibrin sealants depends on the thrombin-catalyzed formation of a fibrin clot. However, neither the purity nor the concentration of the main components of fibrin sealants (thrombin and fibrinogen) is uniform across all commercial products and this will affect performance. In addition, the optional inclusion of other components such as factor XIII and antiproteolytic inhibitors may also influence the quality of clot formation. Properties that vary among different fibrin sealants, such as the clotting rate, viscosity, adhesiveness, clot strength and resistance to proteolysis, are all-important considerations for the surgeon. The application of fibrin sealants in a very wide spectrum of surgical procedures means that some fibrin sealants may be more suitable for a particular procedure than others. One of the advantages of commercial fibrin sealants is that the high level of quality control ensures that their composition is extremely consistent between batches. On the other hand, blood bank-derived fibrin sealants may vary in their composition from one preparation to the next and hence be less predictable in their performance. This paper discusses how individual components contribute to the overall performance of fibrin sealants, thereby providing to the surgeon the necessary information to select the optimal fibrin sealant for a specific procedure.