Burns cause approximately 180,000 deaths annually, with the majority occurring in low–middle income countries.1 Burns are a worldwide public health concern, causing human injury, mortality and disability.1 Moreover, injuries due to burns are associated with extreme pain and suffering that can impair a patient's quality of life.
Ineffective treatment of burn wounds lead to major economic and psychological impacts and long-term somatic sequelae,2 thereby imposing additional costs on the healthcare system. It is, therefore, essential to develop proper and effective treatments for burn wounds.
Wound dressings have found wide applications in recent years as a remedy to abate pain, reduce burn-related problems, protect against fluid loss and infection, and accelerate the recovery process of patients' burns (human performance and scar appearance).3 There is a wide range of wound care dressing types available, such as traditional gauze dressings, biologic dressings and synthetic dressings.4 There is evidence for the efficacy of each type of dressing, dependent on wound type but newer dressings benefiting from advances in technology can be more advanced with regards to ease of care, reducing pain and healing time, protecting against fluid loss and infections, and improved functional properties and affordability.3,4,6,7 Many treatment protocols are now available for first and third-degree (full-thickness) burns, however, the choice of treatment cannot be easily made, particularly in the case of partial-thickness.5 As a solution, synthetic dressings have been increasingly used in recent years in the treatment of superficial partial-thickness burns,3 particularly as a replacement for biological dressings that can be associated with problems of being animal-derived,8 and associated high cost.6 Suprathel (PolyMedics Innovations, Germany) is a novel biosynthetic wound dressing6 that serves as a temporary epidermal substitute in partial-thickness burns.9
This study was designed to explore the scientific evidence in support of the effectiveness, safety, and cost-effectiveness of the novel biosynthetic wound dressing for use by the healthcare sector.
Methods
In this systematic literature review, ‘Suprathel’, ‘effectiveness’, ‘safety’, and ‘cost’ were selected as keywords. Possible synonyms and alternative spellings of all the terms were also included. The PubMed, Cochrane, Scopus and Embase databases were searched for the selected keywords in the titles and abstracts of published articles, including studies using the novel biosynthetic wound dressing in burns treatment, with no limitation on publication year (up to December 2017) or geographical region. The search was restricted to publications in English.
Once duplicate publications had been excluded, all remaining abstracts and, in cases where the abstract was deemed not sufficient for extracting useful data, some full texts were reviewed. Of the remaining articles, papers that solely studied progress in burn injuries7,10,11,12,13,14 and evaluated different technologies15,16,17,18 were subsequently excluded. To assess the included studies in terms of their quality, the Consort 2010 checklist was used. The quality evaluation showed that 80% of the studies were ranked good with respect to their titles, abstracts, and introductions. When it came to the sections on methods, however, our evaluations showed that the selected studies met only 40% of our predefined criteria, particularly with respect to sample size, randomisation and statistical methods. Furthermore, the sections on discussion and results were found to include only half of the items required.
Results
The literature search identified 102 publications. After exclusion of duplications, 33 articles remained, of which 18 solely focusing on the progress in burn injuries7,10,11,12,13,14 and evaluated different technologies15,16,17,18 were subsequently excluded. This left 14 relevant publications (Table 1). Among the articles reviewed, the highest frequency belonged to those published in 2011 (n=3) while six articles were related to studies in Germany. Based on our review, the articles were classified into the following three categories: safety, effectiveness, and cost.
Table 1. Characteristics of included publications
| First author | Year | Patients, n | Study design | Aim | Main findings | Quality of study (consort) |
|---|---|---|---|---|---|---|
| Everett et al.20 | 2015 | 17 | Pilot trial | Evaluate the efficacy and outcomes of the appliation of copolymer dressing | That patient may be discharged shortly after the application of the copolymer dressing, with manageable pain scores and ease of use as determined by the care taker's high satisfaction | 50.0% |
| Fischer et al.25 | 2016 | 1 | Care report and literature review | Comprehensive review about Suprathel use, especially older, high-risk patients | Wound dressing changes were performed without the need for additional sedation or pain medication and thus diminishing the risk of drug-related affection of blood pressure and cardiac function | 37.5% |
| Glik et al.26 | 2017 | 30 | Retrospective, unblinded, matching pair case-control | Assess the impact of a porcine-derived wound dressing (Oasis for application to hand burns compared to a synthetic dressing (Suprathel) | Application of the Oasis wound dressing prevented the formation of scar contractures and resulted in a good aesthetic outcome. But the differences between the hospitalisation time were not observed | 66.7% |
| Highton et al.8 | 2013 | 33 | Prospective study | Evaluate the use of Suprathel1 for partial-thickness burns in children | Suprathel is an effective skin substitute for the treatment of partial-thickness burns in children | 37.5% |
| Keck et al.24 | 2012 | 18 | Prospective, non-blinded controlled non-inferiority study | To compare Suprathel with autologous skin, based on healing time and scar quality in deep-partial-thickness burn | Suprathel represents a solid, reliable epidermal skin substitute with longer healing times in comparison to skin grafts but comparable results concerning early scar formation | 66.7% |
| Lindford et al.27 | 2011 | 1 | Case report | To report experience in the use of Suprathel and allograft skin in a severe case of Toxic epidermal necrolysis | Suprathel enables easier application, less exudation with fewer dressing changes, reduced pain, and earlier re-epithelialisation. Histological analysis reveals a lack of the epidermal granular layer in the allograft-healed skin | 25.0% |
| Madry et al.9 | 2011 | 21 | — | Assess the usefulness of Suprathel in the treatment of partial-thickness burns and to determine the preferable time of Suprathel application to the wound | Suprathel is a good dressing that can perform the function of a temporary epidermal substitute in partial-thickness burns | 33.3% |
| Markl et al.23 | 2010 | 77 | Prospective, randomized, single-blinded, clinical study | Evaluating three different synthetic wound dressings for treating split-thickness skin graft donor sites | The investigated materials did not differ with regard to quality and acceleration of the healing process, but Biatain-Ibu seems to be the most appropriate dressing material in terms of cost-effectiveness | 58.3% |
| Pfurtscheller et al.28 | 2014 | 1 | Case report | Treatment of extensive blistering phototoxic dermatitis in children as second degree thermal burns | Suprathel proved ot be an excellent temporary epidermal and dermal skin substitute in this case | 29.2% |
| Rahmanian-Schwarz et al.3 | 2011 | 34 | Retrospective, matching pair | To provide objective data on the long-term outcome of Biobrane and Suprathel | Using both substitutes, we observed satisfying results in superficial partial-thickness burn treatment, without any significant differences. Since the treatment of burned patients is associated with high socioeconomic load, the cost factor should be one of the most important criteria in dermal substitute selection | 62.5% |
| Rashaan et al.21 | 2016 | 21 | Prospective, observation study | Evaluation of usability and effectiveness of Suprathel in the treatment of partial-thickness burns in children | Muprathel provides potential advantages regarding pain and scar formation, but extensive wound debridement is needed to achieve adequate adherence | 50.0% |
| Schwarzee t al.22 | 2007 | 22 | Prospective, randomised, two-centre clinical study | To evaluate the impact on wound healing of Suprathel in donor sites of split-thickness skin grafts | Suprathel represents a solid, reliable epidermal skin substitute with an impact on wound healing, patient comfort and ease of care. Material effectiveness contributes to the reduction of overall treatment costs | 58.3% |
| Schwarze et al.5 | 2008 | 33 | Prospective, randomised, bicentric, nonblinded, clinical study | To evaluate the impact on wound healing of Suprathel in partial-thickness burn injuries | Suprathel represents a reliable epidermal skin substitute, with a good impact on wound healing and pain reduction in partial-thickness burn injuries. Although it is less cost-effective than Omiderm | 58.3% |
| Uhlig et al.19 | 2007 | 22 | Randomised, nonblinded clinical study | Comparing Suprathel versus paraffin gauze on split skin donor sites and Suprathel versus Omiderm on second-degree burns (degree 2a, partial thickness burns) | Suprathel significantly reduced pain. Its easy handling was superior compared to other materials. The Suprathel membrane adhered rapidly to the wound thus protecting against infections and promoting wound healing | 50.0% |
While no study specifically addressed the safety or side-effects of the novel biosynthetic wound dressing, the studies maintained that safety could be assessed by allergic reaction and infection. According to these studies, no allergic reactions had been reported since the novel biosynthetic wound dressing had come into use in 2007.19 Moreover five studies examined infections with the novel biosynthetic wound dressing; including Schwarze et al. and Everett et al.15 no infection was observed.
Regarding effectiveness, Rashaan et al.21 studied the use of the novel biosynthetic wound dressing in children with burns and indicated the potential benefits of this dressing in relation to pain and scar. The authors, however, recommended extensive wound debridement in order to achieve adequate adherence.21 Furthermore, Highton et al.8 mentioned the advantage of using the novel biosynthetic wound dressing for mid-dermal burns in children.> With regard to healing time and re-epithelialisation, the reviewed studies showed no significant differences between the novel biosynthetic wound dressing and Biobrane (Smith+Nephew, UK),3 Omiderm (Dr Spiller, Australia)5 or Jelonet (Smith+Nephew, UK).22 However, all these studies highlighted benefits of the novel biosynthetic wound dressing, including significant reduction in patient pain, the possibility of accurately monitoring wound healing, improved scar appearance and no damage to the wound surface. In general, the studies considered effectiveness from different perspectives such as impact on pain,5,19,20,21,22,23,24,25,26 healing time,5,22,24,27 and scar appearance.24,27
Cost is one of the most important criteria for choosing a treatment. It may be assessed in terms of both material cost and total cost. Material cost refers to the purchase price of the dressing and the ancillary materials needed for that dressing. Total cost includes the material cost and the care cost (nurse and physician care). Based on the studies reviewed, the limiting factor for the use of the novel biosynthetic wound dressing was its cost. This is evidenced by the costs reported in different studies which listed the highest material costs for different dressings:
Novel biosynthetic wound dressing (€90/patient) versus Jelonet (€50/patient)22
- Novel biosynthetic wound dressing (€0.7/cm2) versus allogenic material (€1.06/cm2), amnion (€0.85/cm2), Xenoderm (Medical Biomaterial Products GmbH, Germany, €0.29/cm2), and Omiderm (€0.10/cm2)5
- Novel biosynthetic wound dressing (€100) versus polyhexanide gel (€50)25
- Novel biosynthetic wound dressing (€148.5) versus Biatain-Ibu (Coloplast, Denmark, €18.89) and Mepitel [Mölnlycke, Sweden] (€26.24).23
Clearly, the novel biosynthetic wound dressing is only cheaper than allograft skin (€0.5/cm2 versus €0.81/cm2). It does however the advantage that Suprathel is a one-time application product whereas the other products need to be reapplied, therefore the total product costs are lower over the whole course of treatment. In general, the cost for 90cm2 was estimated at €70–100,24 or €0.7–1.1/cm2 in various evaluations. In addition to the cost of the wound dressing, the total cost can be influenced by various parameters such as reduced dressing change times,3,5,19,20,22,23,24 ease of care, reduced visits for professional care,5,19,20,22,23,25,28,27 and reduced need for medications.20 The use of the novel biosynthetic wound dressing has been shown to reduce the care time for both nurses and physicians from 30 minutes per day to 15 minutes per day,22 or the time required for each dressing change from two hours to one hour.25 However, some of the reviewed studies reported contrasting results when they compared the novel biosynthetic wound dressing with alternatives: lower total cost of the novel biosynthetic wound dressing (€6450) compared with polyhexanide gel (€7000),25 and a higher total cost of the novel biosynthetic wound dressing (€151.01) than those of Biatain-Ibu (€30.35) and Mepitel (€55.18).23 Schwarze, and Everett report lower costs and compared to historical averages the treatment was deemed cost-effective. Lindford et al.27 highlighted the ease of use and no specific storage as advantages of the novel biosynthetic wound dressing that reduce the treatment costs when compared with the allograft skin.27
Fig 1 depicts comparisons of the novel biosynthetic wound dressing and its alternatives.
Discussion
Based on the results obtained, the novel biosynthetic wound dressing is a suitable choice for partial-thickness burns and donor site grafts. The criteria used for selecting an ideal wound dressing include the promotion of re-epithelialisation, minimisation of pain, reduction of patient discomfort and cost-effectiveness.22 Studies that evaluated biologic or synthetic dressings as alternatives to the novel biosynthetic wound dressing did not report any significant differences in terms of effectiveness,3,5,22,23,26 although they reported different results with the dressings when used in comparison with skin grafts.24,27
The major differences between the novel biosynthetic wound dressing and other products are associated with pain relief, ease of care and cost-effectiveness. In most studies, significantly lower pain was reported for burn injuries treated with the novel biosynthetic wound dressing.
Compared with Oasis (Smith+Nephew, UK), however, the novel biosynthetic wound dressing was reported to have higher experienced pain scores.26 Some studies also identified beneficial properties of the novel biosynthetic wound dressing such as good wound attachment, transparency for wound monitoring, and fewer dressing changes.5,9,20,22,23,27 Nevertheless, the cost of the novel biosynthetic wound dressing was reported as detracting from its cost-effective and an important factor limiting its use.5,7,22 Although it can be said that although the material costs are higher compared with the other dressings, the total costs are lower. Due to this proven effectiveness Suprathel has become a standard in burn care in Europe, the United States and Latin America.
Limitations
The studies reviewed were not high in quality due to the limited number of randomised clinical trials as well as absence of control groups and case reports. As the novel biosynthetic wound dressing is manufactured in Germany, most of the reviewed studies belonged to this country.
Conclusion
Despite the above reports, the scientific evidence to make reliable conclusions about the novel biosynthetic wound dressing needs to include data from after 2017. RCTs and cost-effectiveness studies are recommended to be conducted in order to assess the dressing against other wound dressing alternatives.
Reflective questions
- What factors influence the choice of dressings in wound care?
- What are the clinical indications for the use of Suprathel?