Clinical Newsletter
Regular updates on our latest clinical studies.
Our research and development teams operate at a global level and generate synergies from our collective expertise and by drawing on related disciplines. We are also constantly exchanging information at an international level with independent technical institutions, key opinion leaders and multipliers in order to be able to ensure cooperation and knowledge management of the highest order. As part of this process, we also conduct extensive research, the results of which we continually present in workshops, at conferences and symposiums - either in documentation or talks given by our cooperation partners - and also publish in renowned scientific journals. This database contains a large number of these evidence-based scientific articles, most of which have been evaluated by independent assessors:
Debridement is a basic necessity to induce the functional process of tissue repair, especially in chronic wounds. In this pilot study the authors used a new debrider technology with specific monofilament fibres in a unique texture to evaluate its efficacy, safety and tolerability. In eleven patients, exhibiting all types of wound-associated debris (biofilms, slough, necrotic crusts and hyperkeratotic plaques), the debrider, wetted with physiological solution, was wiped without specific force over the wound for about 2-4 minutes. This led to removal of almost all debris leaving healthy granulation tissue intact, including small epithelialized islands of vital tissue. The procedure was without pain and adverse events. Scanning electron microscopic analyses identified the majority of the removed debris tightly packed within the monofilament texture. A surgeon who blindly assessed pictures taken before and after the debridement categorized all except one wound without the need for surgical debridement and ranked all the debridement results with the new debrider as 'very good' (best category). This formulates the basic concept that the new debrider-based technology is easy, fast, highly efficient, well tolerated and cost effective.
Wound debridement is an often-ignored area of wound care due to concerns regarding safety and the ability of clinicians to carry out what can be a delicate procedure. This article examines a series of case studies featuring a new selective method of mechanical debridement (Debrisoft® , Activa Healthcare). The paper presents the findings from 18 patients who were selected for a one-off treatment using this new method of debridement.
OBJECTIVE
To evaluate the wound debridement efficacy (that is, achievement of 100% granulation tissue on the wound bed) of a new monofilament fibre product (Debrisoft).
METHOD
This multicentre, prospective, observational evaluation assessed the debridement efficacy, safety, patient comfort and user satisfaction of this new product. Time taken to perform the debridement procedure was also recorded. The new product was wetted with either saline or polihexanide and applied for 2-4 minutes, following which the usual dressing regimen was applied. Clinical outcome was scored by a trained clinician. Additionally, before and after photographs were assessed by one and the same clinician, who was blinded to the treatment given. The debridement outcomes achieved with the test product were compared with results obtained using other methods of debridement, both non-surgical and surgical, taken from an electronic database but using the same scoring systems as here.
RESULTS
Sixty patients with chronic wounds requiring debridement were recruited, of whom 57 were included in the analysis. Debridement was effective in 93.4% (142/152) of the sessions, and the product remained intact in 95.4% (145/152). The average time for each debridement session was 2.51 minutes, markedly less than for the current debridement methods at the evaluation centres. Visible debris and slough were successfully removed with the test product. Patients reported no pain during the procedure in 45% of cases and slight discomfort for a short duration (2.0 minutes on average) in 55% of cases.
CONCLUSION
The results indicate the potential for this monofilament fibre product to replace several modes of debridement, based on its efficacy, short procedure, ease of use and patient comfort.
CONFLICT OF INTEREST
The evaluation protocol was proposed and supported by Lohmann & Rauscher GmbH, who provided the evaluation products. MS and MA are employees of Lohmann & Rauscher. The other authors declare to have no relevant financial interest in the evaluation. Apart from input to the protocol, the sponsors had no role in the conduct of the study, such as data collection, analysis, or preparation, review, or approval of the manuscript.
AIM
The optimal pressure to reduce chronic extremity swelling is still a matter of debate. The aim of this paper was to measure volume reduction of a swollen extremity depending on the amount of pressure exerted by compression stockings and inelastic bandages.
METHODS
Thirty-six patients with unilateral breast cancer related arm lymphedema were investigated in a lymph clinic in the Netherlands, 42 legs with chronic edema of the lower extremities were examined in a phlebological centre in Italy. The arm-patients were randomized to receive inelastic arm bandages with a pressure between 20-30 mmHg or 44-68 mmHg. The leg patients were either treated with compression stockings (23-32 mmHg) or with inelastic bandages (pressure 53-88 mmHg). Water-displacement volumetry and measurement of leg circumference was performed before and after compression.
RESULTS
In the arm-patients low pressure after 2 hours achieved a higher degree of volume reduction (-2.3%, 95% CI 1.0-3.6) than high pressure (-1.5%, 95% CI 0.2-2.8) (n.s.). In patients with leg edema compression stockings in the range between 20 and 40 mmHg showed a positive correlation between exerted pressure and volume reduction, bandages applied with an initial resting pressure of more than 60 mm Hg resulted in a decreasing volume reduction.
CONCLUSION
There is obviously an upper limit beyond which further increase of compression pressure seems counterproductive. For inelastic bandages this upper limit is around 30 Hg on the upper and around 50-60 mmHg on the lower extremity.
Currently, there are no generally accepted definitions for wounds at risk of infection. In clinical practice, too many chronic wounds are regarded as being at risk of infection, and therefore many topical antimicrobials - in terms of frequency and duration of use - are applied to wounds. Based on expert discussion and current knowledge, a clinical assessment score was developed. The objective of this wounds at risk (W.A.R.) score is to allow decision-making on the indication for the use of antiseptics on the basis of polihexanide. The proposed clinical classification of W.A.R. shall facilitate the decision for wound antisepsis and allow an appropriate general treatment regimen with the focus on the prevention of wound infection. The W.A.R. score is based on a clinically oriented risk assessment using concrete patient circumstances. The indication for the use of antiseptics results from the addition of differently weighted risk causes, for which points are assigned. Antimicrobial treatment is justified in the case of 3 or more points.
OBJECTIVE
To evaluate the clinical benefits, primarily tolerability and reduction in pain levels, associated with the use of a PHMB-impregnated biosynthetic cellulose dressing (Suprasorb X + PHMB) on paediatric heel lacerations.
METHOD
These lacerations were caused when children, who were being transported on their parents' bicycles, got their heels trapped in the wheel spokes. Where these injuries just comprised skin contusion and laceration, treatment had previously comprised cleansing followed by application of conventional dressings and moist wound healing dressings. However, the high incidence of infection necessitated regular dressing changes, which caused parents and children stress and anxiety. This clinical evaluation assessed the benefits of a new treatment protocol, where the PHMB-impregnated biocellulose dressing was applied and left in situ until epithelialisation occurred. A cork splint was used for 3 days to prevent pes equinus and to let the ankle joint rest. Change in wound size (cm²), incidence of local infection, wound bed characteristics and pain levels (measured on a 0-10 paediatric pain scale) were assessed at 3-day intervals during the 14-day treatment period. Satisfaction with the dressing was also evaluated.
RESULTS
Twenty children (mean age 5.6 years (± 1.33) were recruited into the study and included in the analysis. The mean baseline wound area was 8.60cm² (± 6.57). The mean time to complete wound closure was 12.95 days (± 7.69) with a mean total of 4.70 visits (± 1.56). The mean VAS pain score was 9.55 (± 0.69), compared with 0.15 (± 0.37) on day 14 (p<0.003). At the second visit (after 3 days) 17 of the 20 children were reported to be free of pain. No cases of local infection were noted.
CONCLUSION
The dressing was found to be child and parent friendly. The evaluation also showed that it was well tolerated and achieved good healing outcome. It has now been incorporated into the clinic's treatment protocol for these wounds.
CONFLICT OF INTEREST
None. The authors have no relevant financial interest in this article. All authors were involved in the critical revision of the manuscript for important intellectual content.
OBJECTIVE
This cohort study evaluated the clinical efficacy of a polyhexanide-containing biocellulose dressing, Suprasorb X+PHMB (Lohmann & Rauscher GmbH), for the eradication of biofilms in non-healing wounds. Polyhexanide (PHMB) has been shown to have microbicidal activity when applied to chronic wounds and burns.
METHOD
Twenty-eight patients, aged over 18 years, who presented at an outpatient wound clinic with non-healing locally infected and/or critically colonised wounds of various aetiologies that showed clinical signs of biofilm were included in the study. Sixteen patients (nine females), with a mean age of 60.9±21.6 years, were included in the analysis. The patients were prospectively followed for a maximum of 24 weeks or until healing for analysis of safety and efficacy endpoints. Evolution of wound size was conducted with tracings and standardised digital photographs as well as for determining healing rates.
RESULTS
At 24 weeks,12 wounds (75%) had healed (complete epithelialisation with no drainage). Of those wounds that had not closed, the mean wound area had reduced by 61% at week 24. Ten patients (63%) had a good reduction of the biofilm, five (32%) scored moderate and one (6%) had no reduction noted at week 24. The mean percentage of granulation tissue had increased significantly (p<0.04) when comparing day 0 (38%) with week 24 (77%). Yellow tissue present in the wound bed decreased (p<0.01): 62% (day 0) versus 23% (week 24). All patients reported reduced pain after dressing change.
CONCLUSION
The results suggest that continuous application of PHMB, using a biocellulose wound dressing, reduced biofilm in the stagnating wounds treated, thus promoting healing. The treatment was comfortable, safe and reduced wound pain at dressing change. The PHMB-containing biocellulose dressing seems to be suitable for lightly to moderately exuding wounds.
DECLARATION OF INTEREST
This study was supported by a scientific grant from Lohmann & Rauscher.