Clinical Newsletter
Regular updates on our latest clinical studies.
Onze teams van Onderzoek en Ontwikkeling zijn wereldwijd werkzaam, en creëren synergieën met onze deskundigheid en verwante vakdisciplines. Wij wisselen internationaal veel van gedachten met onafhankelijke, gespecialiseerde instituten, belangrijke opinieleiders en kennisverspreiders om zo samenwerkings- en kennismanagement op het hoogste niveau te kunnen garanderen. In het kader daarvan voeren wij grote studies uit die voortdurend op congressen in de vorm van posters of lezingen van onze partners, op symposia en in workshops worden gepresenteerd, en ook in befaamde wetenschappelijke tijdschriften worden gepubliceerd. De voor het grootste deel door onafhankelijke deskundigen beoordeelde, op bewijs gebaseerde vakpublicaties stellen wij u graag in deze databank ter beschikking:
Background and Aims
In the management of leg ulcers and hyperkeratosis of the surrounding skin, it is not uncommon for them to affect very large areas of the leg. The large size also leads to an increase in the level of exudate and the amount of devitalised tissue. As a result, a larger amount of material is needed to loosen and remove the devitalised tissue than is the case with smaller wounds. To evaluate the performance of this debridement pad optimised for larger wounds and the surrounding skin, a small case series was performed.
Methods
For the case series leg ulcers of various origins that needed debridement were treated once or over a longer period of time with the larger pad when indicated. The treatment was documented both photographically and in writing.
Results
Five patients between the ages of 64 and 83 were treated. All of them suffered from chronic ulcers covering a big area on their legs. At least some of the wounds were colonised with bacteria/biofilm. Two patients were suffering from hyperkeratosis, too. The debridement with the debridement pad was well tolerated by the patients. Biofilm as well as devitalised tissue were removed effectively. All wounds were healed or becoming better.
Conclusions
Most of the time one pad was sufficient, even for ulcers spreading to cover the entire gaiter area. A much larger area could be treated efficiently and quicker than it would have been possible with a smaller device. In addition, the enlargement of the device is accompanied by an increase in the absorption capacity for exudate, slough and debris.
Objective:
A small-scale quality improvement study to determine the clinical effectiveness and patient satisfaction of the long-handled monofilament fibre (Debrisoft®) debriding lolly on foot ulcers that were considered to be slow healing in nature.
Methods:
This was a non-comparative, small-scale quality improvement study conducted on ulcers with slough (non-fibrous) at the ulcer base. The longhandled monofilament fibre (Debrisoft®) debriding lolly was used to treat seven patients during ulcer management, following the Trust's guidance for podiatric ulcer treatment.
Results:
Improvement was noted to the majority of ulcers within the second to third week and visible changes were evident, particularly in healing times and slough reduction. Both user and patient satisfaction were high.
Conclusion:
The long-handled monofilament fibre (Debrisoft®) debriding lolly provides an easy-to-use method of debriding foot ulcers. It allows easy access to difficult areas and enables the healing mechanism to commence. Patients verbally reported positive satisfaction when the long-handled monofilament fibre (Debrisoft®) debriding lolly was used.
Background
Evidence supports the use of adjustable compression wraps (ACW) in the intensive phase of complex decongestive therapy (CDT), whereas evidence of its use in the maintenance phase of oedema therapy is sparse.
Methods
Randomised controlled non-inferiority trial in the maintenance phase of oedema therapy (CDT phase II) of symmetric lymphostatic oedema of the lower leg. Oedema therapy was performed with ACW and custom-made flat knit compression stockings (FCS) as a reference therapy in parallel over 3 days in n = 30 subjects. The primary outcome was lower leg volume as measured with perometer. Safety of ACW self-application and the patient perspective were secondary outcomes.
Results
ACW is non-inferior to custom-made FCS in CDT phase II of lymphostatic lower leg oedema. The differences of volume effects lie within the apriori defined equivalence interval of ± 50 ml (p = 0.163; 95 %-CI [ − 38.2; + 6.8]). Self-administration of ACW has shown no relevant side effects. ACW are easier to put on and off, while wearing comfort is comparable.
Conclusions
ACW are an alternative therapy option in the maintenance phase of CDT. Self-application seems to be safe, subject to diligent instruction of patients. Patients with difficulties putting on and off compression stockings could benefit from the use of ACW. Patients with pronounced limb volume may need to wear shoes with bigger sizes when wearing ACW. Further research with a longer observation time is to follow.
Ziel
110 Jahre nach Heinrich Fischers Veröffentlichung “Eine neue Therapie der Phlebitis” (7) möchten wir Daten aus unseren mobilen Grenzflächen-Druckmessungen unter nicht nachgiebigen Fischer-Verbänden veröffentlichen. Wir zeigen die biologisch physikalischen Gesetzmäßigkeiten auf, die über das Phänomen des biphasischen Druckaufbaus für die deutlich höheren Arbeitsdruckwerte unter nicht nachgiebigen Materialien im Vergleich zu nachgiebigen Kompressionsmedien beim schnellen und ausgedehnten Gehen verantwortlich sind.
Methoden
Wir verwendeten das von der Universitäts-Hautklinik Tübingen in Zusammenarbeit mit dem MIPM 1996 entwickelte Kompressionsdruck-Messsystem MCDI-1 (20) in der Spezialversion PIVI. Es arbeitet mit einem piezoresistiven Sensor. Darüber modellierten wir einen fixierten nicht nachgiebigen Unterschenkelkompressionsverband nach Heinrich Fischer (18). Die Gehstreckenlänge betrug 2 km, die Gehgeschwindigkeit 5,5 km/h. Die auf dem Handydisplay wiedergegebenen Einzelwerte wurden mit einer Digitalkamera gefilmt und danach zur Auswertung in Super-Slow-Motion ausgelesen. Dasselbe Verfahren durchlief ein Kompressionsstrumpf (KKl-2).
Ergebnisse
Bis zu einer Gehstreckendistanz von ca. 300 m liegen Fischer-Verband und Kompressionsstrumpf (KKl-2) mit intermittierenden Druckamplitudenspitzen von 80 mmHg gleichauf. Danach entwickelt sich die Phase 2 des biphasischen Druckanstiegs unter dem nicht elastischen Verband: Die Druckamplitudenspitzen steigen kontinuierlich weiter an, bis nach ca. 800 m ein Plateau mit einem durchschnittlichen Spitzendruck von 200 mmHg erreicht wird. Die Druckspitzendauer beträgt < 1/10 Sekunde.
Schlussfolgerung
3 Kraftquellen sind an der Druckgenese bei der Kompressionstherapie beteiligt: 1. der externe Anpressdruck des Kompressionsmediums, 2. die interne Kraft aus der Filament-Gleit-Schwellung der kontrahierenden Muskulatur, 3. die interne Kraft aus der zeitverzögert einsetzenden belastungsabhängigen vaskulär-metabolischen Pumpeffekt-Schwellung der Muskulatur. Sie ist verantwortlich für das spezifische Phänomen des biphasischen Druckanstiegs unter nicht nachgiebigen Kompressionsmedien. Der Anpressdruck (Anlagedruck) des Kompressionsmediums wirkt bei der nachgiebigen und nicht nachgiebigen Kompressionstherapie gleichermaßen. Die beiden internen Kraftquellen (Filament-Gleit-Schwellung und Pumpeffekt-Schwellung) summieren sich und entfalten nach Gehstrecken größer 800 m biphasisch eine Kraft, die je nach Steifheit des nicht nachgiebigen Materials im Binnenraum unter dem Verband (für < 1/10 sec.) vollständig in Druckkraft übergeht. Unter einer nachgiebigen Kompression verpufft diese Energie zum größten Teil in der Elastizität des textilen Materials. Beim flotten und ausgedehnten Gehen entwickeln sich deshalb (biphasisch) signifikant höhere Druckamplituden als unter elastischer Kompression. Als Resümee behält der alte phlebologische Leitsatz (15) “Therapie mit nicht nachgiebigen Verbänden und einem Laufprogramm, Halten des Ergebnisses mit Kompressionsstrümpfen” weiterhin seine berechtigte Gültigkeit.
Schlüsselwörter
Arbeitsdruck, Ruhedruck, Grenzflächen-Druckmessung, Biphasische Druckentwicklung, Filament-Gleit-Schwellung, Pumpeffekt-Schwellung, nicht nachgiebiger Kompressionsverband, nachgiebige textilelastische Kompression.
Background
Adjustable Compression Wraps (ACW) are used as an alternative to flat-knitted compression stockings (CS) in the maintenance phase of complex decongestive therapy treating of lymphoedema.
Methods
Self-applied ACW and custom-made CS were compared using sub-compression interface pressure measurements in vivo. Measurements were recorded using manometer-based Picopress®-devices in a sample of n = 30 probands with bilateral symmetric lymphostatic lower leg oedema. Legs were randomised to CS side and ACW side. Following standardised instruction and initial pressure measurements for both systems, ACW pressure measurements were repeated after 2 and 4 hours. Static Stiffness Index and pressure gradients between measuring points B1-C were calculated.
Results
ACW showed resting pressures and SSI in therapeutic ranges and significantly higher than CS (p < 0.01; p < 0.001). ACW reached significantly higher working pressures (p < 0.001). Resting pressure sub-ACW did not show significant pressure drops after 2 and 4 hours, without re-adjusting. Average pressure gradients between ACW and CS did not differ significantly.
Discussion
The pressure values reached with ACW underline their therapeutic effects. Pressures under self-applied ACW are relatively stable, even without re-adjusting. Self-application is interpreted as effective. A thorough instruction of patients is essential.
Compression therapy for venous and lymphatic conditions may be delivered via a range of treatment modalities using many different technologies, depending on the patient's condition and needs. Clinical decision-making relies on accurate assessment of the patient, their presenting and underlying clinical condition, skill and training of the applier and the available resources. However, changes in the patient's condition or lifestyle may necessitate re-evaluation of the treatment pathway. Generally, compression bandages and Velcro wraps are used in the intensive acute phase of treatment, with self-management using compression hosiery or wraps being used for long-term maintenance to prevent recurrence. Although guidelines recommend the highest class of compression hosiery for maximum effectiveness, clinical evidence shows practical challenges associated with application and tolerance of higher pressures and stiffness. An audit of a new type of compression garment was conducted, and it showed that incorporating stiffness into circular knitted hosiery helped overcome some of these challenges with improvements in limb size, skin softening and wound size. Additionally, self-management was facilitated by the ease of donning and doffing.
The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5-0.8) occurs as in mixed leg ulcers (MLU).
MATERIALS AND METHODS
in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure 40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU.
RESULTS
Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = -0.19).
CONCLUSIONS
when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.
PURPOSE
Management of staple line leaks (SLL) after sleeve gastrectomy (SG) is challenging. The aim of this study was to evaluate the effectiveness of a novel endoscopic vacuum therapy (EVT) modality in the management of sleeve leaks.
MATERIALS AND METHODS
Eight patients were treated with EVT for SLL. Therapy data and outcome measures including duration of therapy, therapy success, and change of treatment strategy were collected and analyzed.
RESULTS
During the study period, SLL occurred in 1.6% of patients who underwent SG. After 9.8 ± 8.6 days of EVT, 3.3 ± 2.2 endoscopies, and 19 ± 15.1 days of hospitalization, endoscopic treatment using EVT was successful in seven out of eight patients (87.5%).
CONCLUSIONS
EVT is an effective method for the management of staple line leaks after sleeve gastrectomy. The use of the intraluminal open-pore film drainage (OFD) could be considered as an advantageous modality of EVT, regarding placement and complications.