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Introduction

This clinical evaluation was conducted to validate the usage of a three step treatment plan for patients with highly exuding leg ulcers which included monofilament fibre pad, superabsorbent dressing and cohesive, short stretch bandages. The primary outcome measure was a reduction in the levels of exudate of patients with highly exuding leg ulcers with a simple three step approach. The secondary outcome measures were reduction in nurse visits, reduction in pain, reduction in materials cost, increase in patient quality of life.

Method

The trial design was a planned sample size of 10 patients over a 4 week period with a review at 2 weeks. The inclusion criteria was that all patients in the trial must have had a full holistic assessment with an Ankle Brachial Pressure Index (ABPI) of between 0.8 and 1.3. Patients must be willing to tolerate a full compression system and must be experiencing issues with ‘leaky legs’/ highly exuding leg ulcers. The exclusion criteria included non-concordant patients and patients with an ABPI of lower than 0.8 or higher than 1.3

Results

Three patients who had previously been in a reduced compression system became non concordant towards the end of the trial due to wanting to be more comfortable and although had significant improvements in wound healing which have been included in the results, could not be included in the cost analysis. One patient was hospitalised during the trial and therefore had to be removed from the analysis. Eight patients have had the leg ulcer for longer than 12 months and 90% of patients were in no compression or a reduced compression system. Regarding the Doppler assessment, 100% of patients had a doppler assessment and 90% of patients had a doppler reading between 0.8 - 1.3. Before the evaluation started, 5 patients had very high exudate and 5 patients had moderate exudate levels. Fifty percent of patients had had those levels of exudate for over 6 months and forty percent of patients for between 3-6 months. After the evaluation one patient was admitted to hospital for an unrelated reason and so couldn’t complete the trial. From the remaining 9 patients 7 had dramatically reduced exudate levels to low. When looking at the patient pain scores pre and post evaluation, 8 out of the 10 patients recorded a pain score pre evaluation and 6 post evaluation. All 6 patients reported a reduction in pain with an overall 45% reduction in pain. Reduction in wound size area was recorded in 9 cases and in all 9 cases there was a reduction in wound size of between 0.5cm and 5.5cm in dimensions. During the 4 week evaluation in 9 patients, there was a 58% reduction in nurse visits.The total number of nurse visits per week across 6 patients before the clinical evaluation was 24 and this reduced to 11 visits per week after the clinical evaluation. Across the same 6 patients there was a weekly product cost saving of £145. Before the clinical evaluation started 9 out of 10 patients stated that their leg ulcer affected the quality of their life. At the end of the 4 week evaluation, 7 out of 9 patients reported an improvement in their quality of life and expressed some thought provoking comments.

Discussion and conclusion

Many patients who have venous leg ulcers experience high levels of exudate and pain and this may lead the healthcare professional and patient to decide that implementing full, therapeutic compression is not possible. They may opt for ‘reduced compression therapy’ or ‘light bandaging’ thinking some compression is better than nothing. This evaluation clearly demonstrated in a small group of patients that by implementing a three step solution of effective wound bed preparation using a monofilament fibre pad, a high quality superabsorbent dressing and full, therapeutic compression has a dramatic effect on exudate levels and pain experienced by the patients. This leads to reduced nursing visits, reduced costs and ultimately, an improved patient experience and quality of life.

Aim:

NPWT has been advocated for virtually all kinds of acute and chronic wounds. Treatment is based on local negative pressure applied to the wound surface. NPWT is mainly carried out using open-cell polyurethane foams. It could be shown that cells show a significant tendency to grow into these foams which can be inhibited by application of drainage foil** without interfering with induction of cell migration. It is of interest to investigate if this combination is robust and workable with different vacuum pumps***.

Method:

Drainage foil** was placed on fibroblast 3D-cultures in combination with largepored PU foam*. Assemblies were positioned in Petri dishes and sealed with air-tight film after medium supply and vacuum pumps*** were connected. Experiments were carried out at -80mmHg and -120 mmHg for 48h. Cell viability and ingrowths of cells into samples was

determined.

Results / Discussion:

Combination of drainage foil** and PU foam* samples during NPWT with different vacuum pumps*** led to the same cellular responses in vitro. With the PU foam* alone, cells did not stop at the pellicle edge but continued to migrate into the

dressing. In contrast, placement of drainage foil** between collagen pellicle and PU foam* inhibited ingrowths of cells into the foam.

Conclusion:

It was shown that combination of drainage foil** with PU foam* for NPWT is workable with pumps from different manufacturers***. Ingrowths of cells into large-pored foams can be inhibited in vitro by application of drainage foil**. In vivo this may prevent disruption of newly formed tissue during dressing changes.

Aim:

A polyacrylate containing super absorbent dressing* can be used for patients with moderate-to-high exuding wounds. The study evaluated the performance of the superabsorbent dressing* in daily clinical practice.

Method:

German physicians from different specialisms participated: 23 general medicine, 13 surgery, 14 internal medicine and 3 other departments. Both the dressing and questionnaire were supplied by the sponsor. After dressing use the physicians scored on handling properties, absorbent capacity, user satisfaction and patient comfort. The super absorbent dressing* was used for at least 3 dressing changes in 171 patients (86 (50.3%) men, 78 (45.6%) women, 7 (4.1%) not scored).

Results / Discussion:

The centers used their current protocol. The patients had pressure ulcers (8 (4.7%), venous leg ulcers (113 (66%), diabetic foot ulcers (8 (4.7%), post-surgery (14 (8.2) and infected wounds (8 (4.7%). Dressing application was rated easy by 168 (95%) of the clinicians and the dressing demonstrated a good absorbent capacity as noted by 167 (98%) of the respondents. The dressing was rated easy to remove (168 (98.3%) and did not soil clothing according to 165 (97%) of the respondents. N=157 (94%) patients reported to be satisfied with the performance of the dressing as well as 166 (99%) of the physicians, who additionally reported (156 (94.6%) the dressing to be safe and reliable for the task at hand.

Conclusion:

The study design allowed for collecting data on the dressing in daily clinical practice. The evaluated dressing* was easy to use, comfortable and reliable for patients with moderate-to-high exuding wounds.

Aim:

Compression remains the gold standard for long-term management of chronic edema. Reviews have shown that the benefits of compression diminish according to levels of non-adherence. Reasons commonly stated for nonadherence to compression include inconvenience, heat, cost, and pain. We hypothesize that offering compression options will have positive impact on patients’ compliance and concordance to compression regimens.

Method:

Observational study performed at 2 different edema management clinics. Ten patients presenting with lower extremity swelling and history of non-compliance with previous compression regiments were observed. Objective data measured included limb volume, range of motion (ROM), functional activity status using the Timed Up and Go(TUG), and assessment of quality of life (QOL) using the Lymphoedema QOL Tool (LYMQOL-LEG). Measurements were taken at four different intervals over a minimum of 3 months. Compression options were individualized to patient's physical presentation and lifestyle for long term management of their edema.

Results / Discussion:

Compression therapy had a positive impact on all outcomes measured during the intensive phase of therapy. Follow-up outside the intensive phase of therapy demonstrated further volume loss in 6/10 subjects; Volume remained constant 3/10, increased slightly 1/10. LYMQOL scores and functional performance level maintained stable during the follow-up period.

Conclusion:

Offering multiple compression options including custom and ready-to-wear flat knit stockings*, an adjustable wrap ** and nighttime compression options*** had a positive impact on patients’ adherence to compression regimens during the study period compared to single compression modalities offered previously. Individualizing the compression regimen to each patient’s lifestyle improved their adherence to chronic edema management.

Aim:

To review the evidence supporting the use of Monofilament fibre debridement technology (MFDT) in dermatological conditions.

Method:

MFDT has been successfully used for 7 years in the debridement and management of chronic wounds¹ and hyperkeratosis². In recent years clinicians have been utilizing the MFT in specific dermatological skin conditions.

Results / Discussion:

MFDT has been shown in case studies and case series to be a useful emerging treatment, especially when self-care is a priority, in the management of dermatological conditions resulting in:

 Varicose eczema

 Epidermolysis bullosa

 Chronic wounds in dermatological patients

 Dry, scaly and flaky skin conditions

 Hyperkeratosis associated with venous disease

 Secondary skin changes associated with chronic oedema and lymphoedema

 Actinic keratosis

 Prior to photodynamic therapy

 Acne vulgaris

The 18 million special monofilament fibres which have angled tips to reach uneven areas of the skin or wound bed are able to remove unwanted tissue, materials and skin, allowing other concurrent treatment to reach their target area without the barriers imposed by for e.g. devitilised tissue, dry, scaly and flaky skin and other debris and materials. This technology has received positive NICE guidance¹⁷ for use in acute and chronic wounds. MFDT is very soft, comfortable and gentle on patients. It is safe and easy to use and can also be used by patients for self-care.

Conclusion:

A review of the supporting evidence clearly supports the continued research and interest in MFDT related to dermatological conditions.

Aim:

To evaluate the performance of Monofilament Fibre Debridement Technology compared to a cleaning cloth in the removal of bacteria and biofilm using a wound intelligence device which leverages the principles of fluorescence.

Method:

Patients were selected with chronic wounds who demonstrated signs that biofilm was the primary cause of the wound being static or slow to heal. A monofilament fibre debridement pad was used to mechanically debride the chronic wounds and expedite wound bed preparation. The same procedure was repeated using a cleaning cloth with poloxamer following manufacturer’s instructions for use. A wound intelligence device was used to take images of fluoresce in bacteria ≥ 10⁴ CFU/g on the surface of the wound bed before and after using the monofilament fibre debridement pad and compared with the before and after images using the cleaning cloth.

Results / Discussion:

To date, eight patients have been recruited into the evaluation, four using the monofilament fibre debridement pad and four using the cleaning cloth. In all cases, images demonstrate that the monofilament fibre debridement technology has superior ability to removal bacteria and biofilm when compared to the cleaning cloth with poloxamer. Data collection continues.

Conclusion:

To date, the monofilament fibre debridement technology has shown better removal of bacteria and biofilm when compared with a cleaning cloth using fluoresce imaging in the evaluation.

Aim:

The study compared clinical efficacy and cost of autolitic, enzymatic and mechanical debridement using a monofillament pad* and a pad with a handle.

Method:

A monofilament debrider was proposed for its efficacy, safety, tolerability and ease of use. Eighty community patients with complex wounds containing sloughy tissue were allocated to the treatment groups at random, after they consented. They were followed for 15 days. At baseline medical history, wound characteristics and privious treatment was recorded. During visits wound condition, patient reported pain during debridement, time required for the procedure and product handling, were scored. Costs calculation took into account clinical efficacy, time to debridement, number of home visits, nursing costs, costs

per product used.

Results / Discussion:

Debridement was effective and comfortable using all evaluated methods (on a 5-point Likert scale, the 2 monofilament products scored a mean of 4,9 and 4,8, enzymatic sored a mean of 4,6 and autolytic debridement a mean of 3,6). The total costs for debridement using the monofilament pad* and product with handle was Euro 58,67 and Euro 72,47 respectively. For enzymatic debridement the total costs were Euro 213,35 and for autolytic debridement Euro 98,67. Cost was significantly lower in the monofilament group due to a reduction in debridement time, number of visits and nursing time.

Conclusion:

The addition of the monofilament products to our debridement portfolio use for wound management in the community represents an added value in the treatment available for patients with complex wounds with appropriate use of tight resources.

Aim:

Although hosiery is the golden standard in the maintenance phase for treating lymphedema or venous leg ulcers, clinical challenges exist where hosiery may not be suitable due to unresolved edema or practical application issues. In this study a practical solution for this group of patients was implemented using a Leg Ulcer Hosiery Treatment System.*

Method:

9 patients, 5 males, 4 females aged between 45 – 87 years old. 7/9 edema, I erysipelas and I DVT. Previous treatment: 6/7 no treatment, 2 Tubigrip, 1 ill-fitting hosiery Referrals from the General Practitioner or Medical Specialists to the bandager Medical Stockings measurement. In all cases edema persisted and an alternative solutions was chosen using the new system for 4 – 6 weeks for treatment of the edema.

Results / Discussion:

After evaluation, there was an immediate effect reduction in edema, from 6 to 14%. Comfort and Donning was good to very good. Doffing was average to good. Patients were able to wear their own shoes, stay active and in some cases, continue working. They were measured for follow on Medical Stockings. The system was simple, effective, promoted self-care and was available off the shelf. Costs of bandager and community nurse time were reduced.

Conclusion:

Simple solutions such as the 2 layer Leg Ulcer System can help patients and caregivers for the treatment of edema with or without a wound. Benefits are self-management and cost efficiency instead of 2 – 3 x week bandaging. All patients could fit into their own shoes, and this motivates mobility.

Aim:

Complex case management in a fragile elderly patient to achieve an optimal outcome.

Method:

The 96 year-old female had a deep wound infection after osteosynthesis of her left ankle. In the hospital she was treated with negative pressure wound therapy (NPWT). Upon arrival on March 2, 2017 in the rehabilitation centre the wound surface was 8 x 3 cm, the wound bed contained 10% yellow and 90% granulation tissue with some hyper-granulation present. The wound edges were non vital and there was oedema in her left ankle. The surrounding skin was slightly red.

Results:

The patient received nutritional supplements twice daily. NPWT was discontinued and the treatment regime now comprised: Debridement using a monofilament1 pad, followed by cleansing with water and disinfection with an antiseptic. The peri-wound skin was protected with a spray on film, a collagen2 and an alginate3 dressing were covered with a superabsorbent pad fixed with an adhesive film dressing.4 Dressing changes were on average twice weekly. For compression 2 layers (20 mmHg) of a tubular compression5 system were applied during the day and reduced to one layer at night. Wound closure was achieved after 41 days of treatment. The patient continued with the compression system for another 6 weeks to protect the fragile area and to prevent oedema from reoccurring.

Conclusion:

Complex wound closure was achieved in a comfortable fashion that suited the individual needs of this elderly fragile patient.

Aims

To evaluate the performance of a gel forming wound contact layer* in static or slow-to-heal chronic wounds following wound bed preparation using monofilament fibre debridement technology**.

Methods

Eleven patients (9 females, 2 males) were selected with low to moderately exuding wounds – 10 of which were leg ulcers. The mean age was 71 years. All patients underwent wound bed preparation using monofilament fibre debridement technology at dressing changes followed by application of a gel forming wound contact layer. The patients were followed up weekly or twice weekly for five dressing changes or until healed. Both quantitative and qualitative parameters were measured at each dressing change.

Results/Discussion

In all cases, the chronic wounds went on to show positive signs of healing, with many reducing greatly in size or healing.

The gel forming wound contact layer resulted in 100% reduction in pain scores during treatment, 100% rated very good application and removal (non-adherent) and 100% rated very good or good improvement of the condition of peri-wound skin.

Results demonstrated very high patient and clinician satisfaction scores with 90% receiving 8 – 10 out of 10.

Conclusion

The gel forming wound contact layer proved easy to use, safe, effective and highly recommended by patients and clinician.