Wound healing is a complex process. Chronic or hard-to-heal wounds are typically defined as wounds that do not heal in an orderly set of stages or within a predicted timeframe (within 3 months) (Vuolo, 2009). There are often underlying medical conditions, such as obesity, diabetes, infection, peripheral vascular disease, malnutrition, vitamin deficiency, advancing age and immobility. Hard-to-heal wounds include arterial leg ulcers (ALUs), venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers.
VLUs are the most common type of leg ulcer (Vuolo, 2009), accounting for 70% to 90% of all leg ulcers (Briggs and Closs, 2003). Signs of VLUs include pitting oedema and haemosiderin staining (hyperpigmentation).
Patients with uncontrolled diabetes may have high plasma glucose levels leading to blood vessel and nerve damage (Bhat et al, 2017). The nerve damage and poor circulation observed in diabetic patients may lead to the development of a foot ulcer. It has been suggested that 1 in 7 diabetic patients will develop a foot ulcer in their lifetime (Reiber, 2001) and good diabetic control is essential to prevent ulcers. If an ulcer is present, it is necessary to prevent it from becoming infected because infection can lead to amputation and long-term disability (Edmonds and Foster, 2006). There are many causes attributed to DFUs such as peripheral arterial disease, diabetic neuropathy and other mechanical forces (pressure, friction and shear).
Having a VLU or DFU has significant cost implications for healthcare institutions, patients, carers, families and wound-care specialists; therefore, it is important for clinicians to assess, treat and manage wounds appropriately. Poor healing rates among those with VLUs and DFUs also affect patient QoL.
There has been extensive literature in support of prudent care and patient-centred approaches to wound-care management (Vuolo, 2009; Wounds International, 2012; Ousey and Atkin, 2013; Wounds UK, 2018; Seckam, 2019). Holistic assessment includes a comprehensive patient history, aetiology of the wound, condition and tissue of the wound bed and periwound area, colour, odour, type and amount of exudate and psychosocial consequences (Vuolo, 2009; Wounds International, 2012; Ousey and Atkin, 2013; Wounds UK, 2018; Seckam, 2019). Precise and timely assessment is paramount to reduce costs and morbidity on patients, their families and wound-care specialists. Vital to wound management is assessment, treatment and management of wound infection. It is therefore important for clinicians to prescribe the correct wound dressing when treating infected wounds.
Various studies have reported on the efficacy of a bacteria-binding dressing (dialkylcarbamoyl chloride (DACC)) in improving wound healing (Chadwick and Ousey, 2019), reducing bioburden in surgical site infections (Gentili et al, 2012) and demonstrating cost effectiveness (Stanirowski et al, 2016a; 2016b). Chadwick and Ousey (2019) highlighted key peer-reviewed clinical evidence for use of bacterial-binding dressings on various wound types citing 29 published clinical studies with a total of 4044 patients. Brambilla et al (2003) demonstrated a reduction in the wound size or complete healing in 85% of cases with an improved QoL for 63 patients with VLUs. Moreover, Gentili et al (2012) reported on the positive clinical outcomes in 75% of cases of chronic arterial ulcers and VLUs. There was also a marked decrease in bacterial load in 50% of cases (Gentili et al, 2012). Other studies have also focused on treating various wound types including postoperative wounds. Wounds treated with Cutimed Sorbact dressings demonstrated a 72% improvement with 21% of wounds completely healing (Kammerlander et al, 2008). Chadwick and Ousey (2019) also reported on a number of other studies demonstrating positive outcomes when using bacterial-binding dressings on VLUs, DFUs, infected pressure ulcers, partial or full-thickness burn wounds and surgical site wounds. It was concluded that the use of such dressings was beneficial in wound bioburden and in the management of hard-to-heal wounds (Chadwick and Ousey, 2019).
It has been increasingly recognised that living with a wound can affect the wellbeing and decrease the QoL of the patient (Charles, 2004; Franks et al, 2016). QoL refers to a ‘person's cognitive assessment of their overall standard of living’ (Upton et al, 2014:14) ie the way the patient thinks about their health condition and how it limits them. Psychological implications can stem from physical (pain, loss of self-image, familial and social isolation) and physiological issues of living with a wound. It has been suggested that negative physiological implications of living with a wound can lead to depression (Ebrecht et al, 2004; Guo and DiPierto, 2010). It has also been estimated that between 27% and 57% of people with hard-to-heal wounds suffer from mood-related disorders (Jones et al, 2006).
It has also been reported that the psychological consequences of wounds such as stress, pain, exudate, malodour, social isolation, immobility, sleep disturbances and negative emotions have potential adverse consequences on the wound and patient (Upton and South, 2011; Upton and Andrews, 2013). In contrast, other researchers have suggested that positive attitudes and wellbeing are associated with better outcomes (Cole-King and Harding, 2001; Upton et al, 2012). Upton and Andrews (2014) and Upton et al (2014) suggested that QoL assessments allow us to compare and evaluate treatment and wellbeing and take into consideration the emotional status of the patient. For most wound-care research, clinical outcomes have been the focus (Green et al, 2014) however, clinicians, healthcare organisations and industry have an important responsibility in considering the patient's QoL in wound management.
Aims
Primary aim
To observe and record the clinical performance and safety of the absorbent and adhesive wound dressing for the intended use during treatment and management of exuding hard-to-heal wounds in daily clinical practice.
Secondary aim
To collate patients' wound-related QoL before and at the end of the treatment with the study product.
Materials and methods
The study was conducted under routine clinical conditions in five international study sites (three German sites and two Polish sites) between April and September 2018.
Ethical considerations
Signed written informed consent was obtained from all patients. The study complied with the Helsinki Declaration. According to local regulations, a positive ethical vote had been obtained in Poland exclusively as needed according to local regulations.
Inclusion and exclusion criteria
The inclusion and exclusion criteria are listed in Table 1.
| Inclusion criteria | Exclusion criteria |
|---|---|
|
|
|
DFU=diabetic foot ulcer; VLU=venous leg ulcer
Study product
Cutimed® Siltec® Sorbact® is a sterile, bacteria-binding, absorbent polyurethane foam dressing for atraumatic dressing changes that contains super-absorbent stripes, which absorb and lock additional wound exudate. The wound contact surface is bacteria-binding, constructed of Sorbact mesh using the Sorbact technology (Chadwick and Ousey, 2019). The fixation border has a silicone coating to minimise trauma and pain during dressing changes. The outer film is water-repellent, but permeable to oxygen and vapour.
Cutimed Siltec Sorbact is indicated for the treatment of clean, colonised, contaminated or infected wounds with moderate to high exudate levels. Cutimed Siltec Sorbact is not intended to be cut. Overlapping of two or more Cutimed Siltec Sorbact dressings should be avoided. A variety of Cutimed Siltec Sorbact dressing sizes (7.0 cm x 10.0 cm (oval), 15.0 cm x 15.0 cm and 17.5 cm x 17.5 cm; all including border) were used in this evaluation study.
Study procedures
Each patient was observed for 28 days, the exact duration depending on the investigator's assessment. Five visits at the study site were documented: initial visit, 3 control visits (7 ± 4 days, 14 + 4 days, 21 + 4 days after the initial visit), and close-out visit (28 ± 4 days)
Eighty-five patients were recruited into this study; 23 patients dropped out (27%). It is important to mention that this study was conducted in Poland and Germany in parallel using the same protocol; however, results were combined for part of the primary outcome measures where indicated according to the impact of local health services. The primary aim was to evaluate the clinical performance parameters of the study product within the intended use in daily clinical practice.
All clinicians involved in this study were informed of the dressing attributes, changes and evaluation process. During first dressing application and subsequent dressing changes, evaluation forms containing non-identifiable patient information were completed. Important information gathered and recorded included:
Wound parameters (clinical performance parameters of Cutimed Siltec Sorbact dressings) were monitored and recorded by clinicians at each visit. These included:
The information gathered also reflected the safety of the product ie skin maceration, skin reactions, pain and adverse events documented by the clinician.
The following product parameters were evaluated in this study:
These parameters were rated by the patients before and after each treatment via questionnaires, which employed the use of a Likert scale (0=insufficient, 1=poor, 2=sufficient 3=satisfactory, 4=good, 5=very good).
The secondary aim was to document patients' perception of their QoL through the use of a wound-specific QoL questionnaire before and at the end of the study. The valid and consistent Wound-QoL questionnaire was used in this study. This questionnaire was developed and validated by Blome et al (2014) (based on the Freiburg Life Quality Assessment for wounds, the Cardiff Wound Impact Schedule, and the Würzburg Wound Score) and subsequently checked for reliability by Sommer et al (2017).
QoL was assessed by the participants before first application of Cutimed Siltec Sorbact and at the end of the study using the Wound-QoL questionnaire. Seventeen QoL measures (Table 2) were scored using a Likert-type scale as either ‘not at all’, ‘a little’, ‘moderately’, ‘quite a lot’ or ‘very much’. The German and Polish results for the QoL measures of this study have been combined.
| QoL measure |
|---|
| 1. My wound hurt |
| 2. My wound had a bad smell |
| 3. There was a disturbing discharge from the wound |
| 4. The wound affected my sleep |
| 5. The treatment of the wound has been a burden |
| 6. The wound made me unhappy |
| 7. I felt frustrated because the wound is taking too long to heal |
| 8. I was worried about my wound |
| 9. I have been afraid of the wound getting worse or of new wounds appearing |
| 10. I have been afraid of accidentally knocking the wound |
| 11. I have trouble moving about because of the wound |
| 12. Climbing the stairs has been difficult because of the wound |
| 13. I have trouble with day to day activities because of the wound |
| 14. The wound has limited my leisure activities |
| 15. The wound has forced me to limit my activities with others |
| 16. I felt dependent on help from others because of the wound |
| 17. The wound has been a financial burden to me |
| Source: Blome et al, 2014 |
Statistical analysis
The data were analysed using a mixture of descriptive and inferential statistics using the Statistical Package for Social Science (SPSS). Data were presented as frequency and percentages for the various clinical performance parameters of Cutimed Siltec Sorbact dressings. Chi-square statistics was used to test whether there were changes in the distribution of wound care parameters at each time period for both the Polish and German sites. Additionally, chi-square statistics were also used to assess differences in QoL before and at the end of the study period for the Polish and German sites.
Results
The results are presented as follows:
Demographic data
Eighty-five patients were enrolled in this study; 23 patients dropped out for various reasons, leaving 62 patients who were suitable for statistical analysis. The eligible patient population was composed of 36 males (58%) and 26 females (42%). Their median age was 67 years (25th percentile: 57.8 years; 75th percentile: 73.5 years). The median observed treatment period was 28 days. Types of wounds treated included VLUs (n=41, 66%), DFUs (n=20, 32%) and one (2%) other wound type. The age and location of wound can be seen in Table 3 and Table 4 respectively with most wounds (76%) being localised on the calf or shin.
| Age of wound | Number of wounds |
|---|---|
| Less than 1 week | 1 (2%) |
| 1 week < 4 weeks | 6 (10%) |
| 4 weeks < 8 weeks | 9 (15%) |
| 8 weeks < 12 weeks | 8 (13%) |
| 12 weeks < 6 months | 6 (10%) |
| 6 months < 1 year | 5 (8%) |
| > 1 year | 27 (44%) |
| Wound location | Number of wounds |
|---|---|
| Thigh | 1 (2%) |
| Calf/shin | 47 (76%) |
| Dorsum of foot | 2 (3%) |
| Sole of foot | 10 (16%) |
| Heel | 1 (2%) |
| Toe | 1 (2%) |
Overall assessment of clinical performance
Patients and clinicians were asked to rate the overall clinical performance parameters of Cutimed Siltec Sorbact (Table 5 and Table 6).
| Parameter | Very good | Good | Satisfactory | Sufficient | Poor | Insufficient |
|---|---|---|---|---|---|---|
| Wearing comfort * | 13 (54%) | 11 (46%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Application of Cutimed Siltec Sorbact | 11 (46%) | 13 (54%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Removal of Cutimed Siltec Sorbact | 14 (58%) | 10 (42%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Adaption to affected area | 8 (33%) | 14 (58%) | 2 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Adhesive power of the border | 5 (21%) | 10 (42%) | 6 (25%) | 2 (8%) | 1 (4%) | 0 (0%) |
| Absorption capacity | 9 (38%) | 13 (54%) | 2 (8%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Absorption capacity under compression † | 4 (44%) | 5 (56%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fluid retention | 10 (42%) | 13 (54%) | 1 (4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fluid retention under compression † | 4 (44%) | 5 (56%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Infection management | 13 (54%) | 10 (42%) | 1 (4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fulfilment of expectation | 9 (38%) | 15 (63%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Overall satisfaction | 9 (38%) | 14 (58%) | 1 (4%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Parameter | Very good | Good | Satisfactory | Sufficient | Insufficient |
|---|---|---|---|---|---|
| Wearing comfort * | 38 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Application of Cutimed Siltec Sorbact | 38 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Removal of Cutimed Siltec Sorbact | 38 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Adaption to affected area | 36 (95%) | 2 (5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Adhesive power of the border | 37 (97%) | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Absorption capacity | 38 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Absorption capacity under compression † | 18 (95%) | 1 (5%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fluid retention | 37 (97%) | 1 (3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Fluid retention under compression † | 19 (100%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Infection management | 22 (58%) | 5 (13%) | 4 (11%) | 5 (13%) | 2 (5%) |
| Fulfilment of expectation | 23 (60%) | 7 (18%) | 6 (16%) | 1 (3%) | 1 (3%) |
| Overall satisfaction | 28 (74%) | 5 (13%) | 4 (10%) | 1 (3%) | 0 (0%) |
Overall, it can be observed that for both the German and Polish sites the clinical performance of the dressing was rated as ‘good to very good’ for most parameters (Table 5 and Table 6). In detail, most clinicians from the German sites rated the overall assessment of Cutimed Siltec Sorbact (Table 5) as ‘very good’ (38%), ‘good’ (58%) and ‘satisfactory’ (4%). Polish clinicians (Table 6) rated the clinical performance of the dressing of Cutimed Siltec Sorbact as ‘very good’ (74%), ‘good’ (13%), ‘satisfactory’ (10%) and ‘sufficient’ (3%).
The German sites had varied responses from ‘very good’ to ‘satisfactory’ for the assessment criteria (Table 5). Clinicians from the Polish study (Table 6) rated several assessment parameters as ‘very good’ (100%) including: the wearing comfort, application of the dressing, removal, absorption and fluid retention capacity under compression of Cutimed Siltec Sorbact. There were various satisfactory ratings for adhesive power of the border (Table 5), infection management and fulfilment expectations (Poland, Table 6).
Wound parameters
Figure 1 to Figure 4 collectively display the wound parameters (visit 1 versus visit 5) investigated in patients being treated with Cutimed Siltec Sorbact from all sites (Germany and Poland). There was a statistically significant difference in the proportion of patients with low exudate before (19%) and after treatment (50%) (Figure 1). There was also an 11% decrease in moderate infected wounds reported by clinicians at visit 5. There was a higher proportion of intact wounds at visit 5 (Figure 2), and a greater proportion of wounds had low viscosity of exudate (Figure 3). Furthermore, the area surrounding the wound was generally more intact and less macerated, red and oedematous at visit 5 (Figure 4).
QoL before and after treatment with dressing
There were statistically significant improvements in QoL measures reported when using Cutimed Siltec Sorbact at visit 5 compared with visit 1, except for QoL measures 2, 13 and 16. A comprehensive description of each QoL measure can be observed in Table 7.
| QoL measure | Not at all (n) | % | A little (n) | % | Moderately (n) | % | Quite a lot (n) | % | Very much (n) | % | Missing value (n) | % | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| My wound hurt | Visit 1 | 19 | 31% | 16 | 26% | 8 | 13% | 13 | 21% | 6 | 10% | 0 | 0% |
| Visit 5 | 25 | 40% | 22 | 35% | 10 | 16% | 3 | 5% | 1 | 2% | 1 | 2% | |
| My wound had a bad smell | Visit 1 | 33 | 53% | 12 | 19% | 8 | 13% | 4 | 6% | 5 | 8% | 0 | 0% |
| Visit 5 | 36 | 58% | 12 | 19% | 6 | 10% | 4 | 6% | 3 | 5% | 1 | 2% | |
| There was a disturbing discharge from the wound | Visit 1 | 18 | 29% | 18 | 29% | 9 | 15% | 5 | 8% | 11 | 18% | 1 | 2% |
| Visit 5 | 31 | 50% | 11 | 18% | 9 | 15% | 4 | 6% | 5 | 8% | 2 | 3% | |
| The wound affected my sleep | Visit 1 | 31 | 50% | 8 | 13% | 7 | 11% | 10 | 16% | 6 | 10% | 0 | 0% |
| Visit 5 | 44 | 71% | 7 | 11% | 6 | 10% | 3 | 5% | 1 | 2% | 1 | 2% | |
| The treatment of the wound has been a burden | Visit 1 | 15 | 24% | 10 | 16% | 7 | 11% | 18 | 29% | 12 | 19% | 0 | 0% |
| Visit 5 | 29 | 47% | 10 | 16% | 9 | 15% | 8 | 13% | 5 | 8% | 1 | 2% | |
| The wound made me unhappy | Visit 1 | 15 | 24% | 9 | 15% | 11 | 18% | 7 | 11% | 20 | 32% | 0 | 0% |
| Visit 5 | 26 | 42% | 7 | 11% | 15 | 24% | 2 | 3% | 10 | 16% | 2 | 3% | |
| I felt frustrated because the wound is taking too long to heal | Visit 1 | 3 | 5% | 16 | 26% | 11 | 18% | 8 | 13% | 24 | 39% | 0 | 0% |
| Visit 5 | 18 | 29% | 12 | 19% | 11 | 18% | 4 | 6% | 16 | 26% | 1 | 2% | |
| I was worried about my wound | Visit 1 | 7 | 11% | 13 | 21% | 5 | 8% | 4 | 6% | 33 | 53% | 0 | 0% |
| Visit 5 | 9 | 15% | 21 | 34% | 7 | 11% | 11 | 18% | 13 | 21% | 1 | 2% | |
| I have been afraid of the wound getting worse or of new wounds appearing | Visit 1 | 8 | 13% | 11 | 18% | 4 | 6% | 7 | 11% | 31 | 50% | 1 | 2% |
| Visit 5 | 19 | 31% | 12 | 19% | 7 | 11% | 12 | 19% | 11 | 18% | 1 | 2% | |
| I have been afraid of accidentally knocking the wound | Visit 1 | 17 | 27% | 8 | 13% | 9 | 15% | 4 | 6% | 23 | 37% | 1 | 2% |
| Visit 5 | 20 | 32% | 13 | 21% | 7 | 11% | 5 | 8% | 16 | 26% | 1 | 2% | |
| I have trouble moving about because of the wound | Visit 1 | 12 | 19% | 17 | 27% | 12 | 19% | 8 | 13% | 13 | 21% | 0 | 0% |
| Visit 5 | 22 | 35% | 18 | 29% | 7 | 11% | 5 | 8% | 9 | 15% | 1 | 2% | |
| Climbing the stairs has been difficult because of the wound | Visit 1 | 22 | 35% | 11 | 18% | 9 | 15% | 8 | 13% | 12 | 19% | 0 | 0% |
| Visit 5 | 27 | 44% | 15 | 24% | 6 | 10% | 8 | 13% | 5 | 8% | 1 | 2% | |
| I have trouble with day to day activities because of the wound | Visit 1 | 15 | 24% | 17 | 27% | 10 | 16% | 9 | 15% | 11 | 18% | 0 | 0% |
| Visit 5 | 23 | 37% | 17 | 27% | 9 | 15% | 7 | 11% | 5 | 8% | 1 | 2% | |
| The wound has limited my leisure activities | Visit 1 | 16 | 26% | 3 | 5% | 16 | 26% | 10 | 16% | 16 | 26% | 1 | 2% |
| Visit 5 | 19 | 31% | 11 | 18% | 12 | 19% | 8 | 13% | 10 | 16% | 2 | 3% | |
| The wound has forced me to limit my activities with others | Visit 1 | 17 | 27% | 6 | 10% | 14 | 23% | 13 | 21% | 12 | 19% | 0 | 0% |
| Visit 5 | 19 | 31% | 12 | 19% | 10 | 16% | 15 | 24% | 4 | 6% | 2 | 3% | |
| I felt dependent on help from others because of the wound | Visit 1 | 20 | 32% | 15 | 24% | 5 | 8% | 10 | 16% | 12 | 19% | 0 | 0% |
| Visit 5 | 30 | 48% | 12 | 19% | 7 | 11% | 4 | 6% | 8 | 13% | 1 | 2% | |
| The wound has been a financial burden to me | Visit 1 | 17 | 27% | 3 | 5% | 5 | 8% | 5 | 8% | 32 | 52% | 0 | 0% |
| Visit 5 | 41 | 66% | 7 | 11% | 4 | 6% | 8 | 13% | 1 | 2% | 1 | 2% | |
There was a statistically significant difference in the perception of wound pain over time (chi-square=25.60, P value<0.001). At visit 5, more patients reported no pain (41% versus 31%) and a little pain (36% versus 26%). At visit 1, 31% of patients reported their pain was experienced as ‘quite a lot’ and ‘very much’. In contrast, at visit 5, 6% of patients reported ‘quite a lot’ or ‘very much’ pain.
There was no significant reduction in the smell of the wound reported by patients at visit 5 (chi-square=1.82, P value=0.77). Conversely, there was a significant reduction in the wound discharge at visit 5 (chi-square=16.96, P value=0.002). Most patients (50%) reported no discharge at visit 5 and 18% reported very little discharge.
There was a statistically significant difference (chi-square=19.66, P value=0.0006) in patients reporting sleep disturbance caused by the wound. Whereas 50% of patients reported no sleep disturbance at visit 1, 71% reported none at visit 5. A statistically significant difference in patients finding that the treatment of the wound had been a burden (chi-square=23.40, P value=0.0001) was also observed. Forty-seven percent of patients reported no burden attributed to the wound at visit 5, compared with visit 1, where 24% reported it. There was also a statistically significant difference in patients reporting the wound's impact on their happiness (chi-square=21.4, P value=0.0002). More patients (42% versus 24%) reported the wound did not make them unhappy at visit 5.
There was a statistical difference in difficulty climbing stairs due to the wound (chi-square=9.29, P value=0.05) reported at visit 5. Patients were better able to climb stairs at visit 5. There was no statistical difference in reported troubles in day-to-day activities (chi-square=9.08, P value=0.06). A statistically significant difference in patients reporting mobility concerns (chi-square=11.54, P value=0.02) was observed.
For other QoL constructs there was a statistically significant difference in the responses as to whether the wound was limiting leisure activities (chi-square=14.02, P value=0.007). At visit 5, 31% of patients reported no limitations to leisure activities and 18% reported ‘a little’. In contrast, at visit 1, 42% of the patients reported their leisure activities were limited ‘quite a lot’ or ‘very much’. This trend was also observed for patients reporting that the wound had forced them to limit activities with others (chi-square=13.37, P value<0.001). The majority (50%) of patients at visit 5 reported ‘not at all’ or ‘a little’ limitation compared with visit 1, which was 37%.
Discussion
The aims of this study were to observe and record the clinical performance of the absorbent bacteria-binding wound dressing (Cutimed Siltec Sorbact) for intended use during treatment and management of exuding chronic wounds in daily clinical practice, and to consider wound-related QoL before and at the end of the treatment.
The use of Cutimed Siltec Sorbact dressing was beneficial in absorbing wound exudate, reduction of the viscosity of wound exudate and therefore more intact and less macerated, red and oedematous wounds were reported at the final visit. The features and benefits of using such dressings have been previously outlined in the literature (Brambilla et al, 2003; Kammerlander et al, 2008; Gentili et al, 2012; Chadwick and Ousey, 2019) and support the findings observed. There was also a statistically significant difference in the proportion of intact wounds before and after treatment. These observations may be linked to the dressing properties and treatment provided by the clinician, including the use of compression therapy, infection management and the bacterial binding properties (DACC) of the dressing. Again, these observations have been well documented in the review by Chadwick and Ousey (2019) and previous research (Brambilla et al, 2003; Kammerlander et al, 2008; Gentili et al, 2012; Seckam, 2019) and may offer some insight into the results observed in this study. Moreover, there was also a decrease in the number of infected wounds and the severity of infection at visit 5. These findings, together with the reduction in performance parameters associated with wound infection, are supported by the literature summarised by Chadwick and Ousey (2019) and previous research by Kammerlander et al (2008) and Gentili et al (2012) documenting the positive effects of using bacterial binding dressings in reducing bacterial load and in infection management.
Most patients rated the wearing comfort of Cutimed Siltec Sorbact dressing as ‘good’ to ‘very good’ Overall, it can be observed that for both the German and Polish sites the clinical performance of the dressing was rated as ‘good’ to ‘very good’ for most parameters. These positive results support the use of this foam dressing in the treatment of VLUs and DFUs; in parallel with previous findings and suggestions by the World Union of Wound Healing Societies (2007), Romanelli et al (2010), Barrett and King (2018) and Seckam (2019), when selecting an appropriate dressing.
This study also employed the use of a Wound-QoL questionnaire that addresses the psychological consequences of living with a wound. It is important to mention that both Germany and Poland have different healthcare systems. For patients enrolled in the study at these Polish sites, treatment was provided for free, whereas in normal medical care situations patients in Poland would have to pay for their treatment, therefore, financial implications differ for the two countries. The majority of Wound-QoL questionnaire constructs were statically significant for the combined (Germany and Poland) QoL measures, highlighting the importance of patient QoL, when using Cutimed Siltec Sorbact dressings to treat VLUs and DFUs. The results observed using the QoL tool help to address those psychological consequences of living with wounds, as outlined earlier (Upton and South, 2011; Upton and Andrews, 2013; Upton and Andrews, 2014; Upton et al, 2014) and complement previous research in relation to QoL with the use of bacterial-binding dressings (Brambilla et al, 2003).
There was also a reduction in stress, pain, exudate, and sleep disturbances, further supporting the suggestion that positive attitudes and wellbeing are associated with better outcomes as highlighted by Cole-King and Harding (2001) and Upton et al (2012). Importantly, considering QoL when using Cutimed Siltec Sorbact had positive implications in both German and Polish cohorts. In support of Upton and Andrews (2014) and Upton et al (2014), this study also adds to the notion of QoL measures permitting clinicians to compare and evaluate treatment, considering the emotional status of the patient.
All in all this study highlights the importance of considering using Cutimed Siltec Sorbact absorbent bacteria-binding foam dressings in conjunction with the QoL questionnaire in wound-care treatment and management (holistic practice) in line with previous research (Vuolo, 2009; Wounds International, 2012; Ousey and Atkin, 2013; Seckam and Mercer, 2018; Wounds UK, 2018; Seckam, 2019). Importantly, Cutimed Siltec Sorbact foam dressings were beneficial in the treatment of VLUs and DFUs. This also builds on the evidence in support of the use of various foam dressings to treat the various wound types (Barrett and King, 2019; Chadwick and Ousey, 2019; Seckam, 2019). Important assessment criteria in relation to Cutimed Siltec Sorbact dressing included wearing comfort (rated by the patient) with clinicians rating the various assessment criteria: the application, removal, absorption with or without compression and fluid retention capacity with or without compression and infection management (all rated by the clinician) as ‘good’ to ‘very good’. Together clinicians from both cohorts were satisfied with the overall use of Cutimed Siltec Sorbact dressings. Such positive implications also add to the growing body of evidence and support the use of Cutimed Siltec Sorbact dressings in the treatment of VLUs and DFUs.
There are various QoL assessment tools available, which can be adapted to wound conditions. Meaume et al (2017) commented on the various tools available recommended by bodies such as the National Institute for Health and Care Excellence (NICE). The Wound-QoL (Blome et al, 2014) was selected because it was found to be internally consistent, valid, and responsive in German leg ulcer patients in the virtual validation analysis. It has also been suggested that it can be used as a short and easy-to-understand instrument to assess health-related QoL in patients with chronic wounds, especially leg ulcers (Blome et al, 2014).
It is important to note that this was a prospective, multicentre, observational study to evaluate the clinical performance and safety of Cutimed Siltec Sorbact absorbent bacteria-binding foam dressings in Germany and Poland and therefore the sample size was not powered accordingly. In the future a power calculation would be beneficial to obtain an appropriate sample size wound type (DFU and VLU). This will add to the validity of the observations presented and make the study more robust.
Regarding QoL measures, social desirability is another important factor to be considered. The results may be biased as some patients may have given a favourable answer to ‘look good’ or please the researcher. These limitations should be considered and therefore results observed here should be interpreted with caution.
Conclusion
The data presented here support the use of Cutimed Siltec Sorbact dressings in wound care for the intended use in the treatment and management of VLUs and DFUs. These findings build on the established research in this area. A unique aspect of this study was adopting the use of the Wound-QoL questionnaire. It can therefore, be deduced that considering such constructs of the Wound-QoL questionnaire allowed patients to become more engaged, involved and concordant with their treatment regimens. In the future, wound-care specialists should adopt a more patient-centred approach in wound care treatment and management for better outcomes. Moreover, the use of wound-specific QoL tools should be routinely included and regularly reviewed in treatment regimens.
Conboy et al (2010) suggested that positive relationships between patients and clinicians improve health outcomes on patient confidence, motivation and concordance (Greenfield et al, 1988). The use of the Wound-QoL questionnaire plays an important role in building the patient's rapport with the clinician. Engaging and placing the patient in the centre of their wound-care treatment and management is important. Furthermore, the efficacy of the dressing in terms of its ease of use, control of exudate, infection management and other positive parameters mentioned previously, contributes to better wound-care outcomes and QoL.