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
Graduated compression is routinely employed as standard therapy for chronic venous insufficiency.
AIM
The study aims to compare the haemodynamic efficiency of a multi-component graduated compression bandage (GCB) versus a negative graduated compression bandage (NGCB) applied with higher pressure over the calf.
METHODS
In 20 patients, all affected by greater saphenous vein (GSV) incompetence and candidates for surgery (Clinical, etiologic, anatomic and pathophysiologic data, CEAP C2-C5), the ejection fraction of the venous calf pump was measured using a plethysmographic method during a standardised walking test without compression, with GCB and NGCB, all composed of the same short-stretch material. Sub-bandage pressures were measured simultaneously over the distal leg and over the calf.
RESULTS
NGCBs with median pressures higher at the calf (62 mmHg) than at the distal leg (50 mmHg) achieved a significantly higher increase of ejection fraction (median +157%) compared with GCB, (+115%) with a distal pressure of 54 mmHg and a calf pressure of 28 mmHg (P < 0.001).
CONCLUSIONS
Patients with severe venous incompetence have a greater haemodynamic benefit from NGCB, especially during standing and walking, than from GCB.
OBJECTIVES
This study was conducted to define bandage pressures that are safe and effective in treating leg ulcers of mixed arterial-venous etiology.
METHODS
In 25 patients with mixed-etiology leg ulcers who received inelastic bandages applied with pressures from 20 to 30, 31 to 40, and 41 to 50 mm Hg, the following measurements were performed before and after bandage application to ensure patient safety throughout the investigation: laser Doppler fluxmetry (LDF) close to the ulcer under the bandage and at the great toe, transcutaneous oxygen pressure (TcPo(2)) on the dorsum of the foot, and toe pressure. Ejection fraction (EF) of the venous pump was performed to assess efficacy on venous hemodynamics.
RESULTS
LDF values under the bandages increased by 33% (95% confidence interval [CI], 17-48; P < .01), 28% (95% CI, 12-45; P < .05), and 10% (95% CI, -7 to 28), respectively, under the three pressure ranges applied. At toe level, a significant decrease in flux of -20% (95% CI, -48 to 9; P < .05) was seen when bandage pressure >41 mm Hg. Toe pressure values and TcPo(2) showed a moderate increase, excluding a restriction to arterial perfusion induced by the bandages. Inelastic bandages were highly efficient in improving venous pumping function, increasing the reduced ejection fraction by 72% (95% CI, 50%-95%; P < .001) under pressure of 21 to 30 mm Hg and by 103% (95% CI, 70%-128%; P < .001) at 31 to 40 mm Hg.
CONCLUSIONS
In patients with mixed ulceration, an ankle-brachial pressure index >0.5 and an absolute ankle pressure of >60 mm Hg, inelastic compression of up to 40 mm Hg does not impede arterial perfusion but may lead to a normalization of the highly reduced venous pumping function. Such bandages are therefore recommended in combination with walking exercises as the basic conservative management for patients with mixed leg ulcers.
AIM
To compare the efficacy of compression stockings and inelastic, high-pressure bandages concerning leg volume reduction in patients with chronic leg oedema.
MATERIAL AND METHODS
Forty-two legs of 30 patients with chronic leg oedema caused by venous stasis were randomized to receive a strong inelastic bandage (IB) or an elastic stocking (ES) exerting a pressure of 23-32 mmHg. Changes in leg oedema were assessed after two and seven days by water displacement volumetry, measurements of leg circumferences and of skin thickness by using Duplex ultrasound. Interface pressure was registered under the compression devices for seven days.
RESULTS
There was no significant difference between stockings and bandages, which both produced a significant reduction in leg volume after two days (-9.6% [95% CI 7.5-11.8] by ES and -11.5% [95% CI 9.9-13.2%] by IB) and after seven days (-13.2% [95% CI 10.4-16.2] by ES and -15.6% [95% CI 12.8-18.4] by IB). Bandages showed a more pronounced reduction in leg circumference and in skin thickness in the calf region. The pressure of IB in the lying position fell from initially 63 to 22 mmHg after two days, but only from 33 to 26 mmHg under ES (median values). The optimal pressure range concerning oedema reduction was found between 40 and 60 mmHg, while higher pressures produced by bandages showed a negative correlation with volume reduction.
CONCLUSIONS
Compression stockings exerting a pressure of around 30 mmHg are nearly as effective as high-pressure bandages with an initial pressure over 60 mmHg in reducing chronic leg oedema.
OBJECTIVE
To compare the clinical efficacy of a collagen dressing covered with a foam dressing with the same foam used as a primary dressing in stagnating granulating pressure ulcer patients.
METHOD
Patients were randomised to receive either a foam dressing (Suprasorb P; Lohmann & Rauscher) as a primary dressing (group A), or a combination of a collagen dressing (Suprasorb C; Lohmann & Rauscher) covered with the same foam dressing (group B).Wound fluid was collected and evaluated prior to treatment (day 0), and on days 3,7, 14 and 21 .The level and expression of matrix metalloproteinases (MMPs) MMP-2 and MMP-9, and tissue inhibitors of metalloproteinases (TIMPs) TIMP- I and TIMP-2,as well as elastase content in wound fluid and angiogenesis,were evaluated, comparing results on day 0 and day 2 I.Time to ulcer healing, reduction in ulcer area, safety of treatment, patient-reported ulcer pain and comfort of the dressing regimen were evaluated as secondary outcomes. Patients received standard preventive measures, in line with the pressure ulcer prevention guidelines.
RESULTS
Ten patients were included in the pilot; five were treated with the foam dressing (group A) and five patients received the collagen dressing, using the foam as a secondary dressing (group B).Wound fluid from group B displayed a significant positive effect on angiogenesis (p < 0.05) compared with group A. In the collagen and foam groupTIMP- I and -2 increased faster and levels were higher than in group A. Furthermore, MMP-2, MMP-9 (p < 0.04) and elastase in group B showed faster and greater decrease in levels, compared with group A, indicating a faster and superior reduction of inflammation. In both groups the ulcers started to heal, with a faster onset of healing for group B.
CONCLUSION
The results of this pilot support published data on the use of collagen dressings compared with foam for stagnating wounds, shown in clinical studies.
DECLARATION OF INTEREST
This study was supported with an educational grant by Lohmann & Rauscher GmbH.Apart from DrAbel, the sponsors had no role in the design or conduct of the study, in the collection, analysis and interpretation of the data, or in the preparation, review or approval of the manuscript. DrAbel gave input to the study design from a scientific perspective. None of the authors received administrative, technical or material support for the conduct of this study.The authors have no other relevant financial interests to declare.
OBJECTIVE
To compare the efficacy of a bio-cellulose dressing (BWD) versus a non-adherent wound contact layer in venous leg ulcer (VLU) outpatients.
METHOD
In a prospective, randomised, controlled multicentre study, 48 VLU patients were randomised to receive compression bandages and either standard care (non-adherent dressing; n=23) or a BWD (Suprasorb X; n=25). VLUs were evaluated for debridement efficacy, time to 75-100% granulation and ≥ 50% re-epithelialisation, reduction of ulcer size and patient-reported ulcer pain, comparing the status at day 0 and weekly, over a 12-week study treatment period.
RESULTS
Thirty-three patients (n=18 BWD and n=15 control dressing) were included in the analysis. Autolytic debridement was significantly faster in the BWD group, with an 84% removal of yellow tissue compared with 26% in the control group, over the 12-week period (p < 0.0001). A median of 25 days were required to achieve 75-100% granulation in the BWD group vs 36 days for controls. A median of 36 days was taken to achieve ≥ 50% re-epithelialisation in the BWD group vs 50 days for controls. Patient-reported ulcer pain reduced significantly faster in the BWD group (p < 0.05), by week 7, 100% of patients reported no pain, compared with 63% of controls.
CONCLUSION
Autolytic debridement was faster and more effective in the BWD group compared with standard care, as was pain reduction. Although the time to healing was shorter with the BWD vs standard care, the difference was not statistically significant.
DECLARATION OF INTEREST
This study was supported by Xylos Corporation. The study product was called X-Cell at the time, and is now available as Suprasorb X (Lohmann & Rauscher). Each principal investigator (Alvarez, Phillips, Menzoian, Etris-Brown) and respective clinical centre received funding for the conduct of the study. Each site executed a clinical study agreement independently with the sponsor. The sponsors had no role in the design and conduct of the study, in the collection, analysis, or interpretation of data, or in the preparation of the manuscript, review, or approval of the manuscript. None of the authors received administrative, technical or material support for the conduct of this study. The authors have no relevant financial interest in this article.
OBJECTIVE
To compare interface pressure (IP) and static stiffness index (SSI) of four different compression systems currently in use for the treatment of patients with venous leg ulcer.
METHOD
Fifty-two ambulatory adults with healthy legs were recruited at random at a study centre after they had consented. The evaluated systems were: short-stretch system (SSB), Rosidal sys (Lohmann & Rauscher), multilayer bandaging (LSB) Profore (Smith & Nephew), Vari-stretch (VSB) ProGuide (Smith & Nephew) and tubular compression (CS) Rosidal Mobil (Lohmann & Rauscher). Interface pressure was measured using Kikuhime (Harada Corp.), placing a 3 cm-diameter probe at the B1 point. IP recording took place in the supine and standing positions, while sitting and during walking, on application of the compression systems and every 15 minutes thereafter for 4 hours.
RESULTS
The IPs of SSB, LSB and VSB, measured immediately after bandage application, were significantly higher than that of CS (all p < 0.05). During the 4-hour study period, the IP for both VSB and LSB measured in the supine position initially increased to > 60 mmHg. Their overall mean IPs in the supine position were 48.96 ± 3.99 mmHg and 48.12 ± 4.57 mmHg, respectively. SSB and CS demonstrated more tolerable IP levels in this position of < 40 mmHg, which was similar to those when sitting. All systems maintained at least 40 mmHg in walking. SSB had a high SSI of 20 throughout the study. LSB followed with an SSI of 18 at the start, which reduced to 13, while the SSI for VSB decreased from 17 to 12 and CS, with an SSI of 6, lagged behind.
CONCLUSION
These results may contribute to the understanding of IP and SSI of the four different compression systems evaluated. The IP and SSI data presented give clinicians an indication of the appropriate frequency of re-application of compression, and preliminary data on choosing a safe and effective compression treatment for their patients.
DECLARATION OF INTEREST
The investigators received an educational grant from Lohmann & Rauscher GmbH & Co KG for this study.
BACKGROUND
In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients.
AIM
This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55-years of age, of short-stretch compression (SSB), four-layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression).
METHOD
Study period was 24-weeks, the primary outcome was the patient functional status, disease-specific and generic health-related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF-12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi-square and the repeated measures analysis of variance test.
RESULTS
A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047).
CONCLUSION
Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment.