Surgical wounds and periwound skin require protection to prevent complications, which affect clinical outcomes and patient quality of life. This study surveyed 45 health professionals treating 394 patients to elicit their experiences of the performance, quality, ease of application and usability of the sterile surgical wound dressing Curapor under routine conditions. Most (90%) wounds were acute, including postoperative wounds, lacerations, cuts and abrasions. The average wear time per dressing was 2.08 days; 94% of patients experienced no dressing slippage and 98% experienced no tape blisters. Curapor was rated good at absorbing exudate. All health professionals reported that their patients thought the dressing was soft or very soft and 98% said that patients found its comfort to be good or very good. The results of the study suggest that Curapor meets the performance requirements for a post-surgical dressing.
To investigate the effectiveness of antimicrobial agents against wound infections, experiments using either 2D cultures with planktonic microorganisms or animal infection models are frequently carried out. However, the transferability of the results to human skin is limited by the lack of complexity of the 2D models or by the poor translation of the results from animal models. Hence, there is a need for wound infection models capable of assessing antimicrobial agents. In this study, an easily standardized wound infection model was established. This model consists of a mechanically wounded human skin model on a collagen matrix infected with various clinically relevant bacteria. Infection of the model led to recognition of the pathogens and induction of an inflammatory response. The untreated infection spread over time, causing significant tissue damage. By applying an antimicrobial-releasing wound dressing, the bacterial load could be reduced and the success of the treatment could be further measured by a decrease in the inflammatory reaction. In conclusion, this wound infection model can be used to evaluate new antimicrobial therapeutics as well as to study host-pathogen interactions.
Modern wound treatment calls for hydroactive dressings. Among the variety of materials that have entered the field of wound care in recent years, the carbohydrate polymer bacterial cellulose (BC) represents one of the most promising candidates as the biomaterial features a high moisture-loading and donation capacity, mechanical stability, moldability, and breathability. Although BC has already gained increasing relevance in the treatment of burn wounds, its potential and clinical performance for "chronic wound" indications have not yet been sufficiently investigated. This article focuses on experimental and clinical data regarding the application of BC within the indications of chronic, non-healing wounds, especially venous and diabetic ulcers. A recent clinical observation study in a chronic wound setting clearly demonstrated its wound-cleansing properties and ability to induce healing in stalling wounds. Furthermore, the material parameters of BC dressings obtained through the static cultivation of Komagataeibacter xylinus were investigated for the first time in standardized tests and compared to various advanced wound-care products. Surprisingly, a free swell absorptive capacity of a BC dressing variant containing 97% moisture was found, which was higher than that of alginate or even hydrofiber dressings. We hypothesize that the fine-structured, open porous network and the resulting capillary forces are among the main reasons for this unexpected result.
BACKGROUND Gentle skin cleansing and exfoliation and the use of moisturizers as an adjunct to medical treatment should be part of the prevention, treatment, and maintenance of cutaneous conditions such as acne vulgaris (acne) psoriasis, and xerosis. A monofilament fiber debriding technology (MFDT) is used for effective, safe, and rapid skin cleansing and exfoliation and debris, slough, and biofilm removal. The current review addresses the clinical experience using MFDT for various cutaneous conditions that require cleansing or exfoliation or both and how to combine it with medical treatment. METHODS A literature review explored clinical insights into the role of skin cleansing and exfoliation for patients with various dermatological conditions. The searches yielded 29 publications, 7 guidelines/algorithms, 13 reviews, 8 clinical studies, and one in vitro study. RESULTS Mechanical cleansing using a device can be helpful; however, avoid injury of the skin as it may result in thickening of the epidermis leading to hyperkeratosis and disruption of the skin barrier. Clinical experience with MFDT for acne, psoriasis, atopic dermatitis, and xerosis is discussed. Additionally, MFDT was used to exfoliate hyperkeratosis, actinic keratosis, and traumatic skin tattoos. CONCLUSIONS Mechanical cleansing using MFDT was shown to be safe and beneficial for skin cleansing and exfoliation of various cutaneous conditions; however, only anecdotal evidence or small studies are available to support its use for these conditions. J Drugs Dermatol. 2022;21(11):1173-1180. doi:10.36849/JDD.6261.
Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.
Wound pH remains in the focus of scientific considerations for the diagnosis and treatment of chronic wounds as emphasized in recent studies [1-7]. Supported by abundant evidence, it may be taken for granted that a rapid acute wound healing occurs with low, acidic pH values at starting points below a pH value of 3. This difference in the wound environmental pH value in acute and chronic wounds has been shown to be relative to differences in the character of exudate which affects pH value [2,3,5,6].
BACKGROUND:Impetigo is a common contagious superficial bacterial skin infection. Treatment of localized lesions can be achieved through topical antibiotics. Oral antibiotics are reserved for extensive disease. Increasing antimicrobial resistance to existing therapies have raised concerns. Antimicrobial stewardship, achieved through the responsible use of antibiotics, is an important measure to re-duce bacterial resistance. This review highlights treatment options for impetigo and shares consensus statements to help guide the management of impetigo in the pediatric population. OBJECTIVE:An expert panel of dermatologists and pediatricians convened in February 2019 to establish evidence-based consensus on the management of impetigo in the pediatric patient population. METHODS:The consensus was created in accordance with the Appraisal of Guidelines, Research and Evaluation (AGREE) II instrument. Prior to the consensus meeting, a systematic literature review was conducted, with the selected literature deemed clinically relevant to the consensus statements. Statements were further refined and assessed systematically following established standards. The consensus process consisted of a modified Delphi approach. The consensus was established through a minimal 75% “agree” rate. RESULTS:Thirteen consensus statements were developed addressing clinical challenges, existing treatment options and their limita-tions, and new therapeutic alternatives. CONCLUSION:Bacterial resistance to antimicrobials commonly used in treating impetigo has been reported. Antimicrobial stewardship is critical to optimize patient outcomes and to prevent the development of resistance. Healthcare providers should be aware of local resistance patterns in impetigo to help guide therapy. The use of newer safe and effective topical antibiotic alternatives as a first-line treatment should be an important step in antimicrobial stewardship.J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.4679.
OBJECTIVE:Due to classification of the agent polihexanide (PHMB) in category 2 'may cause cancer' by the Committee for Risk Assessment of the European Chemicals Agency in 2011, the users of wound antiseptics may be highly confused. In 2017, this statement was updated, defining PHMB up to 0.1% as a preservative safe in all cosmetic products. In the interest of patient safety, a scientific clarification of the potential carcinogenicity of PHMB is necessary.METHODS:A multidisciplinary team (MDT) of microbiologists, surgeons, dermatologists and biochemists conducted a benefit-risk assessment to clarify the hazard of antiseptic use of PHMB.RESULTS:In two animal studies, from which the assessment of a carcinogenic risk was derived, PHMB was administered orally over two years in extremely high concentrations far above the NO(A)EL (no-observed-(adverse-) effect level) in rats and mice. Feeding in the NO(A)EL range resulted in no abnormal effects. In one male in the highest dose group of 4000ppm PHMB, an adenocarcinoma was found, which the author attributed to chronic inflammation of the colon with systemic atypical exposure. The increasing incidence of hemangiosarcomas highly probably resulted from increased endothelial proliferation, triggered by the exceedingly high dosage fed, because PHMB is not genotoxic and there is no evidence for epigenetic effects.DISCUSSION:It is well known that PHMB is not absorbed when applied topically. Considering the absence of genotoxicity and epigenetic effects together with the interpretation of the animal studies, it is the consensus of the multidisciplinary experts that a carcinogenic risk from PHMB-use for wound antisepsis can be ruled out.CONCLUSION:On this basis and considering their effectiveness, tolerability and clinical evidence, the indications for PHMB based wound antiseptics are justified.
OBJECTIVEAcne vulgaris (acne) presents with increased oil-sebum secretion and subsequent formation of comedones, papules, pustules and nodules. Skin cleansing is part of the daily routine to improve skin condition. A monofilament debridement pad has shown to be effective when used for wound debridement and skin cleansing in dermatological conditions. The pad may offer benefits when used for acne affected skin.METHODSThe in vitro cleansing capacity of the monofilament fibre pad was analysed and compared with commercially available cosmetic pads. For this purpose, a sebum model consisting of glass plates coated with an oil-red-stained layer of artificial sebum was used. To gain clinical experience a case series evaluated cleansing efficacy of the monofilament debridement pad in combination with polyhexanide and sodium-hypochlorite based solutions. Over a period of four months, seven individuals suffering from retentive moderate facial acne who visited the dermatology clinic for their acne used the pad as necessary, ranging from twice weekly to daily, dependent on the sensitivity of the patient's skin condition.RESULTSThe in vitro study exhibited a significantly better cleansing efficacy of the monofilament debridement pad compared with the cosmetic pads. After single use of the pad subject scores on sebum reduction revealed excellent/very good in 42.9% and acceptable in 57.1% of cases. After repeated use of the monofilament pads scores on sebum reduction of excellent/very good were given in 85.7% and acceptable in 14.3% of cases. Subject scored handling of the pad and comfort during use also received favourable ratings.CONCLUSIONThese initial results show the potential of the monofilament debridement pad for cleansing of acne-prone and acne affected skin. More robust studies are needed to confirm these results.
Objective: Exudate control is an important aspect of wound management in both acute and chronic wounds. Exudate can be an indicator of the wound bed condition, specifically inflammation and infection. This study aimed to evaluate the performance, in terms of usability, handling properties, exudate management, user satisfaction and patient comfort, in daily clinical practice, of a superabsorbent dressing, Vliwasorb Pro (Lohmann & Rauscher), suitable for the management of moderate-to-very high exudate levels. Method: The user test was conducted between September 2016 and July 2017, with clinicians from different specialisms in 55 centres across Germany. Both the dressing and user test were supplied by the sponsor. The superabsorbent dressing was used for at least three dressing changes, with frequency dependent on the patient and wound condition. Results: A total of 55 clinicians recruited 171 patients with various wound types. The clinicians rated dressing application as ‘easy’ for 163 (95.3%) of the patients. The dressing was rated as easy to remove (168 (98.3%) and, according to clinicians, did not soil patients' clothing in 165 (97.1%) of cases. The dressing demonstrated a ‘good absorbent capacity’, as noted by clinicians in 167 (98.2%) of cases. Clinicians also commented that the dressing reduced foul odour, maceration and improved periwound skin condition. Conclusion: The evaluated dressing was easy to use, comfortable and reliable for patients with moderate-to-very high exuding wounds. In view of these results, superabsorbent dressings seem to be interesting for both clinicians and patients. Clinical studies are required to confirm these results.
Objective: Effective and comfortable debridement is an important part of managing complex wounds. This user test evaluated a monofilament-fibre pad (with handle) (Debrisoft Lolly, Lohmann & Rauscher GmbH & Co. KG) in the debridement of various hard-to-reach wounds. Method: The multicentre, international user test was performed by experienced physicians and nurses in Germany and the UK, who used the monofilament-fibre pad in their clinical practice. After debridement, using the monofilament-fibre pad, the clinicians completed an evaluation questionnaire. The assessment comprised of performance, usability, tolerability, safety and suitability of the device for debridement, comparing it with standard methods used in the clinicians' centres. Results: A total of 23 clinicians in 20 centres each treated between six and 10 patients with the monofilament-fibre pad (a total of 155 wounds of different aetiologies). Most participating patients had deep wounds (n=63 (41%)) or cavity (n=31 (20%)) wounds. When compared with the standard debridement method used at the centres, the tested device was scored as 'easier' or 'equally easy' to use in all cases. When comparing the standard debridement procedure with the monofilament- fibre pad, debridement duration was reported as equal to or shorter than the standard method in 90% of cases when using the monofilament-fibre pad. Debridement efficacy was scored by the clinician as 'better' or 'equal' for the monofilament-fibre pad in 67% of cases. Overall, patients reported that the study device was comfortable. Conclusion: The monofilament-fibre pad effectively, easily and safely removed slough and debris from wounds of various aetiologies and was effective in wounds of different shapes, such as in cavity wounds and those in hard-to-reach locations.
OBJECTIVE::The influence of different irrigation solutions, in conjunction with wet-to-moist cleansing, on the reduction of sessile, non-planktonic bacteria which colonise wounds, has not been investigated. In this study, the antibacterial effect of different irrigation solutions, during a 20-minute wet-to-moist cleansing, has been evaluated in chronic wounds.METHODS::This study was designed as a prospective cohort study with 12 study arms and was conducted between June 2011 and April 2016. Patients with chronic wounds present for more than three months, irrespective of previous treatments, were recruited into this study. Quantitative wound swabs were obtained before and after a 20-minute, wet-to-moist cleansing, using different wound irrigation solutions. Sterile 0.9% saline served as a control.RESULTS::We recruited 308 patients, of which 260 patients with 299 chronic wounds were eligible for analysis. Staphylococcus aureus was the most common recovered (25.5%) microorganism, of which 8% were meticillin-resistant Staphylococcus aureus (MRSA) strains. Although 0.9% saline supported cleansing of the wound bed, it did not significantly reduce the bacterial burden. The highest reduction of bacterial burden was achieved with an aqueous solution containing betaine, zinc and polyhexamethylene biguanide (polihexanide; ln RF=3.72), followed by a 3% saline solution containing 0.2% sodium hypochlorite (ln RF=3.40). The most statistically significant reduction of bacterial burden, although not the highest, was achieved with povidone-iodine (ln RF=2.98; p=0.001) and an irrigation solution containing sea salt 1.2% and NaOCl 0.4% (ln RF=2.51; p=0.002).CONCLUSION::If a reduction of bacterial burden is warranted, wound irrigation solutions containing a combination of hypochlorite/hypochlorous acid, or antiseptics such as polihexanide, octenidine or povidone-iodine, ought to be considered.
Complex stalled wounds feature an alkaline milieu that favors tissue destruction and microbial growth. The presence of bacteria in turn perpetuates the inflammatory response. However, only limited knowledge exists of pH dependency on the antibacterial efficacy of polyhexamethylene biguanide (PHMB) or the influence of surfactants or delivery vehicle used in antiseptic formulations. So far, PHMB alone has been shown to protect the keratinocytes from bacterial damage in such a co-culture system as well as exhibiting increased antimicrobial activity at higher pH values. Here, the interaction of PHMB with the surfactants macrogolum and undecylenamidopropyl betaine that are most commonly used as additives in antiseptics and rinsing solutions such as Lavasept and Prontosan has been explored in addition to the PHMB-containing biocellulose dressing Suprasorb X + PHMB. Undecylenamidopropyl betaine was found to lower the antimicrobial activity of polihexanide in the co-culture system, while macrogolum and the biocellulose increased polihexanide efficiency to reduce Staphylococcus aureus especially in the presence of serum. The increasing antibacterial efficacy of PHMB with rising pH was not altered by undecylenamidopropyl betaine, macrogolum, or the biocellulose. The results suggest that application of PHMB with macrogolum or by delivery through a biocellulose dressing might be advantageous for management of wound infections.
Aim Diabetic foot ulcers (DFU) do not respond well to treatment and cause substantial costs. The topical hemoglobin contact spray Granulox (R) when applied in addition to the standard wound care regimen results in an acceleration of wound healing and an improvement in wound closure even in stalling wounds. Aim of this study is to analyse the impact of a topical hemoglobin contact spray on cost from the perspective of the German statutory health insurance. Methods Based on clinical trial data a 28-week Markov model was programmed covering the following model states: "Stalled Wound Healing", "Normal Wound Healing", "Infected Wound", "Amputation", "Ceased", "Healed". Analysis of incremental differences were performed and tested for robustness with a sensitivity analysis. Results Patients with standard wound care regimen caused average total costs during 28 weeks of 1737 (sic), patients with adjunct topical hemoglobin contact spray resulted in a total of 1028 (sic). Costs for nursing and dressing changes represented the major cost factor with an average of 806 (sic) in standard wound care regimen and 474 (sic) when topical hemoglobin contact spray was added. The cost decrease of 709(sic) was confirmed when varying assumptions in the sensitivity analysis. Conclusion When applying the topical hemoglobin contact spray Granulox (R) in addition to standard wound care regimen of diabetic foot ulcer in Germany a substantial cost reduction could be achieved from the perspective of the German statutory health insurance.
Zusammenfassung Zielsetzung Die Behandlung des diabetischen Fuß-Ulkus (DFU) ist klinisch problematisch und mit hohen Kosten verbunden. Die ergänzende topische Applikation des Hämoglobinsprays Granulox® zusätzlich zum etablierten Therapiestandard der lokalen Wundversorgung erreicht einen schnelleren und häufigeren Wundverschluss insbesondere bei stagnierender Wundheilung. Die Auswirkung der zusätzlichen Gabe des Hämoglobinsprays auf die Kosten aus Sicht der Krankenversicherung soll untersucht werden. Methodik Auf Basis von klinischen Studiendaten wurde ein 28-Wochen-Markov-Modell mit den Modellzuständen „unterbrochene Wundheilung“, „normale Wundheilung“, „infizierte Wunde“, „Amputation“, „verstorben“ und „geheilt“ programmiert. Die inkrementellen Kosten-Unterschiede wurden analysiert und mit einer Sensitivitätsanalyse überprüft. Ergebnisse Patienten in der Standardtherapie des DFU verursachten über 28 Wochen Durchschnittskosten in Höhe von 1737 €, für DFU-Patienten mit zusätzlicher Gabe von Hämoglobin-Spray fielen Gesamtkosten in Höhe von 1028 € an. Behandlungspflege war der größte Kostenfaktor mit durchschnittlich 806 € in der Standardversorgung und 474 € in der um den Hämoglobin-Spray erweiterten Behandlungsstrategie. Die Kostenreduktion von insgesamt durchschnittlich 709 € bestätigte sich in dieser Größenordnung auch bei der Variation der Modellannahmen in der Sensitivitätsanalyse. Schlussfolgerung Durch eine zusätzliche Gabe des Hämoglobinsprays Granulox® können beträchtliche Kosteneinsparungen aus Sicht der Krankenversicherung im Rahmen der Wundversorgung des diabetischen Fuß-Ulkus in Deutschland erreicht werden.
Treatment and handling of infections or special risk situations are without any doubt challenging questions in different fields of medical treatment. Hence, contributions to a better, easier and safer therapy are highly welcome. Following thus, the article published by Röhner and colleagues [1] is an important input to clarify the use of antiseptic substances in bone infection. We, the authors of this letter to the editor, appreciate the information; however, we do feel the need to challenge some aspects and especially the clinical interpretation of this in vitro study.