It is estimated that 10% of people with diabetes will develop a foot ulcer at some point in their lives, with DFUs preceding more that 80% of amputations in people with diabetes (NICE, 2015). For the patient, the impact of a DFU can include symptoms such as pain, restricted mobility, pruritus, sleep disturbances, exudate leakage and malodour (WUWHS, 2016). DFUs can significantly impact morbidity and mortality and can have physical and psychological consequences, as well as substantial financial costs (Haycocks et al, 2018).
Given the complex nature of DFUs, a systematic and multidisciplinary approach to the management of these wounds requires understanding of its multiple confounding factors and aetiologies, and a holistic approach should incorporate appropriate DFU assessment, examination and therapeutic modalities with focus placed not only on evaluating and managing the wound, but also on the diagnosis and treatment of the underlying disease (WUWHS, 2016). Patient-focussed and personalised wound care helps to identify issues that may significantly impact the patient and allows the patient’s fears and concerns to be addressed (WUWHS, 2016).
Pressure reduction through offloading is a key principle of DFU management and several offloading devices are available to reduce or redistribute pressure and shear from the affected site (WUWHS, 2016). There are a range of offloading devices available, including irremovable devices, removable devices, insoles and orthoses, with the choice of offloading device dependent on a range of factors (WUWHS, 2016). There is clinical evidence supporting the use of TCCs in neuropathic, non-ischaemic plantar foot ulceration. The use of TCCs has received a strong recommendation from the International Working Group of the Diabetic Foot (IWGDF) (Schaper et al, 2019) and is generally considered the ‘gold standard’ method of offloading neuropathic plantar DFUs (Messenger et al, 2017; WUWHS, 2016; Schaper et al, 2019). A TCC maintains contact with the entire plantar surface of the foot and lower leg, and immobilises surrounding joints and soft tissues while allowing the patient to remain ambulatory (Messenger et al, 2017). It uses minimal padding to protect the malleoli, tibia shaft and the ulcer. The padding provides total contact to the whole foot while isolating the ulcer (Messenger et al, 2017). Figure 1 shows a TCC in situ.
There are many benefits to the use of TCCs, including the fact that they are irremovable, meaning that patients wear them all the time (Messenger et al, 2017). While the patient can maintain a degree of mobility while wearing a TCC, patients wearing a TCC may be less active when compared to other offloading devices, thereby reducing the number of cycles of repetitive stress (Armstrong et al, 2001; Messenger et al, 2017). Reduced vertical forces on the foot have also been associated with wearing a TCC because of altered pressure distribution, loading times, stride length and walking speed (Hartsell et al, 2002; Messenger et al, 2017). Frictional shearing forces are also controlled when using a TCC (Messenger et al, 2017).
While there is a reasonably strong evidence base in support of the use of TCCs in the management of neuropathic plantar DFUs (despite limitations in methodological robustness of some reported studies) (Bus et al, 2008; Schaper et al, 2019), there are several barriers to the implementation of TCCs, including patient approval and compliance (Raspovic and Landorf, 2014). Reduced ability to access the wound for monitoring and dressing, managing high exudate, fluctuations in oedema and impact on skin condition are among the reported wound-related barriers to the use of TCCs (Raspovic and Landorf, 2014). TCCs may also be contraindicated in certain circumstances; skin abrasions or iatrogenic ulceration, muscle atrophy and reduced bone density associated with the prolonged use of TCCs, leg-length discrepancy resulting in either new or worsening postural instability are all side effects that may be associated with TCCs (Messenger et al, 2017). Furthermore, TCC application requires skill, is time-consuming and is labour intensive (Messenger et al, 2017). However, the benefit of improved compliance of offloading and faster healing times generally outweigh these barriers.
Dressing selection is another key part of DFU management and is important in terms of providing patient wellbeing and optimising the healing process (WUWHS, 2016). However, there is limited evidence to support the use of dressings under TCCs. Exudate management is an important part of wound care and the use of dressings that can absorb and retain excess exudate, while creating a moisture balance conducive to healing is a fundamental aspect of that care (Serena et al, 2019). It is important that the wound management strategy is adaptable to address the changes that occur in terms of the levels and nature of exudate at different phases during the healing process (Serena et al, 2019). The chosen dressing should also protect against excoriation and maceration, should minimise trauma and pain during removal, and should stay intact and in place during wear (Serena et al, 2019).
Comfort and conformability are also key factors to consider when choosing a dressing (Serena et al, 2019). The ability of a dressing to conform to body contours helps to ensure optimal dressing adhesion (Rippon et al, 2015). However, the foot can be a difficult anatomical area to dress and many dressings can be difficult to apply between or over the toes or plantar surface (International Best Practice Guidelines, 2013; Haycocks et al, 2018). For the patient, other issues such as exudate leakage and malodour may also be important dressing performance characteristics to consider (WUWHS, 2016).
Mepilex® Border Comfort
Dressings that are designed in such a way that they are able to remain securely in place under TCCs and effectively handle exudate during that period are likely to promote patient compliance with treatment, while, at the same time, facilitate undisturbed wound healing. Mepilex® Border Comfort (Mölnlycke, Sweden), which is marketed outside of the UK as Mepilex Border Flex, is an all-in-one self-adherent soft silicone coated foam dressing (Figure 2). This dressing is designed for use on a wide range of exuding wounds, such as pressure ulcers, leg and foot ulcers, traumatic wounds (e.g. skin tears) and surgical wounds. It can also be used on dry/necrotic wounds in combination with gels. It comprises:
- A wound contact layer consisting of soft silicone adhesive (Safetac®; Mölnlycke, Sweden) and a film carrier
- A flexible absorbent pad consisting of three layers: an absorbent foam, a non-woven spreading layer and a retention layer with superabsorbent fibres (the wound pad is partly perforated with Flex technology)
- An outer film that is breathable, but impermeable to water, providing a barrier to external contaminants.
Dressings incorporating Safetac wound contact layers readily adhere to intact dry skin and will remain in situ on the surface of a moist wound or damaged surrounding skin without adhering to these fragile tissues (White, 2005). Consequently, such dressings can be applied and reapplied without causing damage to the wound or stripping the epidermis in the periwound region (Meaume et al, 2003). The atraumatic nature of the soft silicone also helps minimise pain during dressing removal (Woo et al, 2009; Patton et al, 2013). The gentle but effective seal that forms between the intact skin and a dressing with Safetac inhibits the movement of exudate from the wound onto the surrounding skin, thereby helping prevent maceration of the periwound region (White, 2005).
The Flex technology (Y-shaped cuts in the retention and spreading layers of the absorbent pad) contributes to the flexibility and conformability of the dressing, and helps to prevent its premature detachment (Haycocks et al, 2018). As well as being waterproof, thereby allowing patients to shower with the dressing in place, the backing layer of the dressing incorporates the unique Exudate Progress Monitor. This dot pattern allows for the easy tracking and recording of fluid as it spreads.
Mepilex Border Comfort is a five-layer dressing which absorbs, channels and traps exudate, keeping exudate away from the wound bed, and preventing the re-entry of exudate, even under compression (Mölnlycke Health Care. Data on file, 2019; Serena et al, 2019). Furthermore, the dressing can handle both normal and viscous exudate (Mölnlycke Health Care. Data on file, 2019 (b); Mölnlycke Health Care. Data on file, 2018).
Based on the positive outcomes experienced in an earlier evaluation of Mepilex Border Comfort (Haycocks et al, 2018), the case studies described in this article were undertaken to evaluate the performance of the dressing when used in the management of DFUs under TCCs. In each case, TCCs (Figure 1) and dressings were applied according to local clinical practice and with the intention of leaving them in place for up to 7 days, depending on logistics and patient availability to attend follow-up visits. Wound size and progression to healing were assessed at each clinic visit. The performance of the dressing under the TCC was evaluated at each clinic visit in terms of the ability of the dressing to manage exudate, to remain in place and to conform to difficult-to-dress anatomical areas.
Aims
The objectives of this study were to evaluate the performance of Mepilex Border Comfort in terms of several in-use characteristics and clinical outcomes when used under TCC as part of the management of exuding DFUs.
Methods
This was a single-centre case series. Ten participants attending the Salford Royal NHS Foundation Trust with exuding DFUs who met the inclusion/exclusion criteria (out-patients) (Table 1) and who were receiving treatment with Mepilex Border Comfort under a TCC as part of their DFU management regimen were included in the study. Each participant was treated according to local routine clinical practice and assessed over a treatment period of up to 4 weeks or until the wound(s) healed, whichever occurred first.
Assessments were made at baseline and at each follow-up clinic visit. Wound size and progression to healing were assessed at each clinic visit. Table 2 lists the wound and periwound status variables that were assessed (assessed after cleansing and/or debridement). All variables were assessed by visual qualitative assessment, apart from wound size, which was measured quantitatively. All wounds had sharp debridement and cleansing with saline if required. Digital photographs of the wound(s) were taken at each clinic visit for each participant, to monitor wound progression throughout the course of the evaluation.
The performance of Mepilex Border Comfort under the TCC was evaluated at each clinic visit (assessed qualitatively using a five-point scale from ‘excellent’ to ‘very poor’ by the clinician) in terms of the ability of the dressing to manage exudate, its ability to remain in place and conformability to difficult-to-dress anatomical areas (Table 3).
A total of 10 case studies were undertaken, three of which (case study 1, case study 4 and case study 9) are described in detail below. Details of all case studies are given in Table 4 and Table 5.
Case study 1
A 62-year-old male with type 2 diabetes presented with two neuropathic DFUs, one to the right plantar first toe and one to the right plantar first metatarsal head, measuring 5 mm x 2 mm with a depth of 1mm and 15 mm x 5 mm with a depth of 20 mm, respectively. Based on the date of initial diagnosis of the wounds, the wounds had been present for 1 week and were being treated with an adhesive foam and a Darby sandal. Both wounds were being treated with antibiotics (clindamycin and co-amoxiclav) for osteomyelitis.
At the baseline visit, Mepilex Border Comfort was applied under a non-removable plaster TCC. The patient attended three follow-up visits during the evaluation period, after which the patient was lost to follow-up.
At the first follow-up visit, the wound to the plantar first toe had healed. The wound to plantar first metatarsal head consisted of 100% granulation tissue, the periwound skin was healthy with a moderate amount of clear/serous exudate. There were no clinical signs of infection. No pain was reported at dressing change (the patient had neuropathy).
At the final follow-up visit (day 21), the wound to the right plantar first metatarsal head measured 10 mm x 10 mm with a depth of 5 mm and was composed of 100% granulation tissue. The periwound skin was healthy and intact, and the wound was producing a moderate amount of clear/serous exudate. There were no clinical signs of infection. No pain was reported at dressing change.
At each visit, where applicable, all dressing performance characteristics were rated as ‘excellent’, including ease of application, ability to remain in place, ease of removal without pain or skin damage and exudate handling capacity.
Case study 4
A 51-year-old male with type 2 diabetes presented with a neuropathic DFU on the plantar region of the right foot. The patient was receiving antibiotics (clindamycin, ciprofloxacin) due to osteomyelitis. Based on the date of initial diagnosis of the wound, the wound had been present for 30 days. The wound had previously been treated with a silver-containing dressing (Acticoat® Flex 3, Smith & Nephew) in conjunction with a superabsorbent dressing (Kerramax Care®, Crawford Healthcare). Prior to the application of the study dressing, dressing changes were being undertaken at the podiatry clinic once a week with the patient changing dressings twice a week between clinic visits.
At the baseline evaluation, the deep wound measured 60 mm x 20 mm. The wound was composed of over-granulation tissue. The periwound skin was macerated and erythematous. Clinical signs of infection included increased warmth, swelling and erythema. The wound was producing a moderate level of clear/serous exudate. No pain was reported at dressing change (the patient had neuropathy). To reduce hypergranulation tissue, a silver-containing dressing (Acticoat Flex 7, Smith & Nephew) was applied to the wound with Mepilex Border Comfort used as the secondary dressing under a non-removable plaster TCC. The patient attended three follow-up visits during the evaluation period. At the second follow-up visit, callous was noted which was debrided.
At the final follow-up visit (day 23), the wound measured 35 mm x 10 mm with a depth of 6 mm and was composed of 100% granulation. The periwound skin was healthy and intact. The wound was producing a moderate (reducing) level of clear/serous exudate. There were no clinical signs of infection. No pain was reported at dressing change due to neuropathy.
At each visit, where applicable, all dressing performance characteristics were rated as ‘excellent’, including ease of application, ability to remain in place, ease of removal without pain or skin damage and exudate handling capacity.
Case study 9
A 50-year-old male with type 2 diabetes presented with a neuropathic ulcer on the plantar second metatarsal head area of the right foot. The wound had been present for approximately 6 months. Prior to commencement of the evaluation, dressing changes were being undertaken at the podiatry clinic once a week with the patient changing dressings twice a week between clinic visits. The wound was being treated with a soft adherent dressing with poly-absorbent fibres, a self-adhesive absorbent dressing (Mepore®, Mölnlycke, Sweden) and an offloading boot with a total contact insole.
At the baseline visit, the wound measured 6 mm x 5 mm with a depth of 4 mm and was composed of 100% granulation. There were no clinical signs of infection. The periwound skin was healthy and intact. The wound was producing a moderate level of clear/serous exudate. No pain was reported at dressing change (the patient had neuropathy). The patient underwent a tendo-achilles lengthening procedure, after which Mepilex Border Comfort was applied under a non-removable TCC. The patient attended three follow-up visits during the evaluation period.
At the final follow-up visit (day 23), the wound was fully healed. There was a small indentation in the scar line. There were no clinical signs of infection. The periwound skin was healthy and intact. There was no exudate present on the wound dressing. No pain was reported at dressing change (the patient had neuropathy). The wound was redressed with Mepilex Border Comfort as the patient was to continue in a TCC for a further 2 weeks.
At each visit, where applicable, all dressing performance characteristics were rated as ‘excellent’, including ease of application, ability to remain in place, ease of removal without pain or skin damage and exudate handling capacity.
Discussion
Of the 11 wounds described in the case studies above, two healed within the study period (one of the wounds in case study 1 healed by the first follow-up visit (within 1 week); the wound in case study 9 healed by follow-up day 23), with the remainder reducing in size and/or improving in appearance within 4 weeks.
Pain and trauma to the wound and periwound skin caused during the removal of dressings can negatively influence wound healing (Haycocks et al, 2018). Atraumatic dressings are designed to minimise the pain and trauma that can be associated with dressing removal. Dressings with soft silicone technology, such as Mepilex Border Comfort, also provide a gentle adhesion, ensuring the retention of wound exudate and prevention of periwound skin maceration by forming a seal between the dressing and the intact skin (White, 2005). Evaluations of the in-use characteristics of the dressing indicated that Mepilex Border Comfort was easy to remove without pain or skin damage. Exudate management is also a key factor in wound care (Tickle, 2013; Tickle, 2016; Haycocks et al, 2018); if excess exudate is not effectively absorbed and retained within the dressing, wounds can become macerated. Mepilex Border Comfort efficiently handled wound exudate under the TCCs in the presented case studies.
The ease of dressing application and conformability are particularly relevant dressing characteristics for the management of DFUs given the awkward anatomical location. In all the cases, Mepilex Border Comfort was easy to apply and remained in place under the TCC for up to 7 days.
Conclusion
While more in-depth studies are needed to substantiate the findings presented here, the results of this case study series are suggestive of the benefits of Mepilex Border Comfort in the management of DFUs when used under total contact casting in terms of exudate management, minimisation of dressing-related complications and optimisation of patient experience. Furthermore, in three of the cases with larger, moderately exuding wounds (cases 6, 7 and 8), cast wear time was increased. The performance of Mepilex Border Comfort allowed the TCCs to be left in situ for the desired length of time (up to 7 days), thus promoting patient compliance with treatment and facilitating undisturbed wound healing.
