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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.

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.

Introduction:

Wound dressings with antimicrobial agents are increasingly utilized in the management of critical colonized or infected chronic wounds. The dressings’ antibacterial activities are mostly evaluated using in-vitro-tests. These may differ significantly in their properties and outcome. We have analyzed the antibacterial effect of PHMB- and silver-dressings using in-vitro-methods such as the agar diffusion test (ADT), contact tests like JISL1902:2002 or AATCC100, microplate-laser nephelometry (MLN) and luminometric quantification of bacterial ATP (LQb).

Materials & Methods:

Antibacterial activity of the dressings was tested against Staphylococcus aureus and Pseudomonas aeruginosa. ADT was performed according to DIN58940-3 with samples of 0.6 cm2. For AATCC100 samples sizes of 18 cm2 and for JISL1902:2002 of 400 mg were used. Dressing extracts were prepared corresponding to DIN10993-12 for MLN and LQb.

Results:

PHMB- and silver-dressings showed antibacterial activity in all tests. Yet, total effectiveness varied for single methods and properties of the basic dressing materials without active agent (such as alginate, cellulose, or polyurethane). Alginate, cellulose, or polyurethane alone had no effect in ADT. In contrast, alginate showed a strong antibacterial activity in the contact tests (JISL1902:2002, AATCC100) because it is able to sequester bacteria during gel formation. MLN and LQb only determined a bactericidal effect on S. aureus and P. aeruginosa for the agent-containing dressings.

Conclusions:

Using in-vitro-tests for the evaluation of the antibacterial activity allows quantification and direct comparison of dressings’ effectiveness under standard conditions. Various test methods are available that differ in their properties and hence in their outcome, this has to be taken into account when selecting a specific test and interpreting the results.

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.

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

This study compares treatment with a polihexanide-containing biocellulose wound dressing (BWD+PHMB) versus the best local standard of silver dressings (Ag) in painful, critically colonised (wounds-at-risk) or locally-infected wounds.

METHOD

Patients with wounds of various aetiologies, a baseline VAS pain score >4 and a semi-quantitative bacterial load of ++ or higher were randomly allocated to receive treatment with either BWD+PHMB or Ag. Patients with systemic infections and/or using systemic antibiotics were excluded. The primary endpoint, patient-reported pain (VAS total pain, including the sub-scores pain at night, during the day, before, and 15min after dressing changes), was compared between treatment groups and scored on days 0, 1, 3, 7, 14, 21 and 28. Secondary outcomes of bacterial load, wound bed and periwound skin condition, quality of life and dressing handling were assessed at the same visits.

RESULTS

Thirty-eight patients (BWD+PHMB, n=21 [24 wounds]; Ag, n=17 [18 wounds]) were included in the analyses. Baseline variables showed no significant differences. Wound pain was reduced significantly in both groups, with a better pain reduction noted for BWD+ PHMB (p<0.001) before dressing changes. Compared with Ag, in the BWD+PHMB group critical colonisation and local wound infection had been reduced significantly faster and better (p<0.001) over the 28-day study period. Improved quality of life, good tolerability and no adverse events were demonstrated for both groups.

CONCLUSION

Both BWD+PHMB and AG were effective in reducing pain and bacterial burden. However, that BWD+PHMB was significantly faster and better in removing the critical bacterial load, makes this dressing an attractive therapeutic option to treat critically colonised and locally-infected wounds.

The effective management of bacterial bioburden is an essential element of wound care. Recent years have seen the increased use of topical antimicrobial dressings to control colonisation and infection, yet there is concern that some may inhibit wound healing and may have systemic sequelae (World Union of Wound Healing Societies (WUWHS), 2008). This article focuses on the safety and effectiveness of PHMB, an antimicrobial compound that is relatively underused in the UK, and argues that it is an effective option for the management of bacterial colonisation and infection.

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.