The Use Of An Antioxidant Dressing On Hard-to-heal Wounds .
practiceThe use of an antioxidant dressingon hard-to-heal wounds:a multicentre, prospective case seriesantioxidant dressing wound healing hard-to-heal woundsHealing was represented by Kaplan-Meier survival curves, and thesewere compared using the log-rank test.Results: A total of 31 patients with hard-to-heal wounds wererecruited. During the 8-week follow-up period, nine wounds (29%)completely healed, of which seven (77.8%) were acute and two (22.2%)chronic. The remaining wounds (22) showed a significant improvementafter treatment with the antioxidant dressing. RESVECH 2.0 scoresdecreased an average of 10.16 points over the 8-week period.Conclusion: The antioxidant dressing could represent an alternative inthe dressing landscape for many types of acute and chronic wounds.Declaration of interest: B. Castro holds the patent that protects thetechnology under the antioxidant dressing. B. Castro and F.D. Bastidawork in the research and development department of Histocell, thecompany that has developed the dressing. oxidative stressWound treatment products andguidelines have significantlyimproved in the past decades,1–3 andmostfacilitiesandhealthprofessionals have completelyabandoned the old dry wound treatment.1,4,5 However,wound closure is not always achieved by just usingmoist wound-healing techniques.The excessive production of reactive oxygen species(ROS) has been associated with oxidative stress oftissues, wound chronification and delayed healing.6 Anexcess of ROS causes a pro-inflammatory environmentin the wound bed,7,8 drawing more inflammatory cellsinto the wound and generating a negative feedbackloop that could delay or prevent wound closure.9,10 The*B. Castro,1 BSc, PhD Chief Scientist Officer; F.D. Bastida,1 DVM, PhD, Senior Scientist–Wound Care; T. Segovia,2 RN, Supervisor, Multidisciplinary Chronic Wounds Unit, ExecutiveMember of Spanish Pressure Ulcers and Chronic Wounds Advisory Panel; P. LópezCasanova,3 RN, MsN, PhD Community Health Nurse; J.J. Soldevilla,4 RN PhD, Professor;J. Verdú-Soriano,1 DUE -RN-, BSc Nurs, MSc Nurs, PhD, Professor*Corresponding author email: bcastro@histocell.com1 Histocell S.L., Bizkaia Science and Technology Park, Derio, Bizkaia (Spain). 2 UniversityHospital Puerta del Hierro, Majadahonda, Madrid (Spain). 3 Health Department of Alcoy,Alicante (Spain). 4 Nursing School, University of La Rioja, Logroño (Spain); Hospital de SanPedro, Servicio Riojano de Salud, La Rioja, (Spain); Head of Spanish Pressure Ulcers andChronic Wounds Advisory Panel. 5 Department of Community Nursing, Preventive Medicine,Public Health and History of Science, University of Alicante, Alicante (Spain).74 2 moist wound carepotent oxidising capabilities of ROS can thereforedamage many of the cell’s molecules and structures.6However, the use of a dressing that can exert theantioxidant effect on wound exudates could restore theappropriate ROS balance.10,11Although the association between oxidative stress inthe wound and hard-to-heal wounds has been aroundfor many years,12 few dressings that address this pointare available.10,13 Honey and honey dressings haveantioxidants that include phenols, flavonoids andvitamins.14 However, honey also contains glucoseoxidase that continuously synthesises the potent ROS,H2O2 at levels sometimes up to 10 times higher thanthose present in the exudate, 9,15,16 complicatinghoney’s role in oxidative stress in wounds. A newantioxidant dressing (company code HR006;commercial name REOXCARE; developed by Histocell)combines an absorbent matrix obtained from LocustBean Gum (LBG) galactomannan and a hydrationsolution with curcumin and N-acetylcysteine (NAC).Curcumin, the natural phenol from the rhizome of theplant Curcuma longa, has been used for over 2000 yearsas an antioxidant, anti-inflammatory and alsospecifically in wounds to improve healing.17–20 NAC iswidely applied as an antioxidant molecule, and morerecently also successfully for the treatment ofwounds.21,22 These three components act as free radicalsJOURNAL OF WOUND CAREVOL 26, NO 12, DECEMBER 2017 2017 MA Healthcare ltdObjective: Oxidative stress can contribute to impaired wound healingand chronic wounds. Our objective was to test the results of a newantioxidant dressing that could help stop the oxidative stress of cells inthe wound bed.Method: A multicentre, prospective case study series was conductedin three Spanish hospitals. The RESVECH 2.0 index was used forhealing assessment. Data from each patient was collected by theattending clinical researchers. Data analysis was performed using thestatistical concept intention-to-treat (ITT). Descriptive results werepresented as frequency and percentages for qualitative variables andmean, standard deviation (SD), range and median for quantitativevariables. For analytical-inferential analyses, incidence of healing wascalculated for chronic and acute wounds. Relative risk (RR) was usedto establish the differences of healing between both types of wounds.
practiceTable 1. Inclusion and exclusion criteriaExclusion criteriaVenous leg ulcersLocal infection in wound area*Neuropathic diabetic foot ulcersPatient under negative pressure wound therapyTraumatic ulcersIntolerance to any of the components of HR006Surgical wound dehiscenceOther ulcer types not included in the inclusioncriteria (ischaemic ulcers)Oncological patients*The following clinical signs could appear in case of local infection: increased drainage; purulent ormalodorous drainage; continuous or increased pain; redness and swelling around the wound; warmtharound the affected area; cellulitis; and delayed healing not previously anticipatedscavengers, and two of them have also a synergisticantioxidant effect.23The antioxidant dressing had previously been testedin an acute wound model in pigs with good results;24however, chronic wounds would be the ideal target forthis type of dressing, since these wounds have aproblem with oxidative stress that arrests the wound inthe inflammatory phase, preventing its progression toother phases of healing.9 In the current study, we testedthe antioxidant dressing in humans in both types ofwounds, acute and chronic.MethodsStudy design and proceduresThis multicentre, prospective case study series aimed toreport the results of the new antioxidant dressing onpatients with acute and chronic wounds in woundclinic facilities at three hospitals in Spain.The study was conducted between September 2013and July 2014. Data collected from each patient by theattending clinical researchers included: Demographic characteristics (age and sex) Patient’s clinical background (concurrent diseases,other medications) Initial description of the wound (aetiology, duration,size, diameter, location, exudate and state ofperiwound skin).A maximum cut-off point of 8 weeks (or healing, ifoccurred before) was established. If wound closure wasnot achieved during the 8 weeks, researchers were giventhe option to continue using the antioxidant dressingas appropriate. Wounds were assessed every week todetermine their state. The RESVECH 2.0 score was usedto assess wound healing.25–27 This scale takes intoaccount six parameters: Size of the lesion Depth and involved tissuesTable 2. Patient demographicsMean age standard deviation years71.7 10.10Range, (median) years44–86, (73)Female:male number (%)20 (64.5%):11 (35.5%) SubjectsPatients over 18 years were recruited in the selectedcentres. The inclusion and exclusion criteria are shownin Table 1. The criteria established for withdrawalincluded any medical condition or lack of concordanceto the study protocol as determined by theclinical investigator.Statistical analysisDescriptive results were presented as frequency andpercentages for qualitative variables and mean, standarddeviation (SD), range and median for quantitativevariables. For analytical-inferential analyses, incidenceof healing was calculated for chronic and acute wounds.Relative risk (RR) was used to establish the differencesof healing between both types of wounds. Also, healingJOURNAL OF WOUND CAREVOL 26, NO 12, DECEMBER 2017 2017 MA Healthcare ltdInclusion criteria74 4Wound marginsType of tissue in the wound bed Exudate Infection/inflammation.The scale is scored numerically, with values rangingfrom 0 to 35 points. Both ends of the scale correspondto a healed or to the worst possible wound, respectively.Data collection sheets for RESVECH 2.0 had clearoperational definitions for each item and the numericalvalue that should be assigned to each variable/condition. The attending professional also recordedtheir opinion regarding the antioxidant dressing’scharacteristics and usability.The sample size was estimated using the programmeG*Power.28 The patients’ data, such us wound durationand previous treatments applied on the wound, beforeincorporation into the study were used as treatmentcontrols. Data analysis was performed using intentionto-treat (ITT),29 where all wounds, even those requiringlonger than 8 weeks to heal, were included in theanalysis. Data from patients withdrawn from the studydue to causes not related to the antioxidant dressingtreatment were also included, in which case the lastregistered RESVECH 2.0 value was extended until theend of the study at week 8.The clinical study protocol was drafted incollaboration with GNEAUPP, the Spanish woundhealing society. The study adhered to all ethicalconsiderations required for this type of studies withmedical devices and conformed with the ethicalguidelines of the 1975 Declaration of Helsinki. TheSpanish Agency of Medicines and Medical Devices(AEMPS) authorised the study (439/13/EC) to take placein three institutions: Hospital Universitario Puerta deHierro Majadahonda (Madrid), Hospital GeneralUniversitario de Elche (Alicante) and Health Departmentof Alcoy (Alicante). Ethics committees at all three centresreviewed and approved the study protocol. Beforeentering the clinical trial and following study protocolguidelines, all patients read the study information, hadthe opportunity to ask questions to the attending nurseor clinician, and signed consent forms.
practice 2017 MA Healthcare ltdA total of 31 patients were recruited. Of these, 11 (35.5%)were men and 20 (64.5%) were women. All patients wereCaucasian and had a mean age of 71.7 10.10 years(range: 44–86; median: 73 years) (Table 2).Most patients suffered from comorbidities, such asdiabetes and lower-limb arteriopathy, and took two ormore drugs to treat these (mainly anticoagulants andantihypertensives). The majority of patients sufferedfrom hard-to-heal wounds. All wounds were located onlower limbs, as per the study’s inclusion criteria. Thewounds’ characteristics are listed in Table 3.Overall, 31 wounds were treated with a mean dressingchange every 3 days. During the 8-week follow-up, ninewounds (29%) completely healed, of which seven(77.8%) were acute and two (22.2%) chronic. Theincidence of healing was 77.8% in acute wounds (sevenout of nine acute wounds healed) and 9.1% in chronicwounds (two out of 22 chronic wounds healed)resulting in an RR of 8.56 of healing for acute versuschronic wounds [95% confidence interval (CI) 2.18 –33.56] (Fisher’s exact test, p 0.001). This RR means thatacute wounds have 8.56 times higher likelihood ofhealing than chronic wounds. The remaining wounds(22) showed a significant improvement after treatmentwith the antioxidant dressing.Only 16 (51.6%) of the 31 patients completed the8-week treatment with the antioxidant dressing.Complications unrelated to the antioxidant dressingtreatment was the only reason cited for patientswithdrawn from the study before 8 weeks (hospitaladmission due to the appearance of other diseases (e.g.pneumonia), infectious agent isolated in the woundthat required specific antimicrobial treatment).The evolution and healing likelihood of acute versuschronic wounds are plotted in Fig 1. The log-rank testwas used to establish whether there were any statisticallysignificant differences between the curves. The curvesclearly show that the performance and activity of theantioxidant dressing is very similar over the first 4 weeksof treatment for both types of wounds. However, afterthat time, while acute wounds progressed quickly toclosure, chronic wounds, as expected, lagged behindand only 22% of them achieved healing at 8 weeks.The results on evolution of wound healing during thestudy, as assessed by RESVECH 2.0, are shown in Fig 2.The data showed statistically significant differences(p 0.001) in wound evolution along time, as determinedby the Friedman test. Data from all wounds, includingthose of patients withdrawn from the study before the8-week period, were included in the analysis (ITT).JOURNAL OF WOUND CAREVOL 26, NO 12, DECEMBER 2017Duration (months), mean standard deviation(range; median)Acute (n 9, 29.1%)3.47 3.07 (0.2–8; 2)Chronic (n 22, 70.9%)65.61 105.31 (1–360; 16)Recurrent (n 13, 41.9%)100.36 128.54 (2–360; 32)Acute (n 0, 0.0%)Chronic (n 13, 41.9%)10.22 15.42 (0.2–60; 6)Non-recurrentRESVECH 2.0 scores decreased an average of10.16 points over the 8 weeks. Surprisingly, by week4, the mean score had fallen 8.32 points from thestart of the study, indicating the important role ofthe antioxidant dressing in wound activation,Fig 1. Evolution and healing likelihood of acute versus chronic wounds.Kaplan–Meier curves show the evolution of healing over time. Censored*cases are represented by marks on the curves1.0Chronic woundAcute woundChronic-censored*Acute-censored*0.8Healing likelihoodResultsTable 3. Wounds’ characteristicsLog-rank test (p 0.044)0.60.40.20024Time to healing (weeks)68Censored—treatment was stopped due to causes not related to the antioxidant dresingFig 2. Evolution of wound healing during the study, as assessed by thestandard scoring system RESVECH 2.0 (error bar represent 95%confidence interval)17.5Friedman test (p 0.001)16.2915.0Mean RESVECH 2.0 scoreswas represented by Kaplan-Meier survival curves, andthese were compared using the log-rank test.To test differences and compare evolution over time,data were analysed using repeated measures ANOVA(Analysis of Variance) and non-parametric Friedman test.Significance was set at an alpha value of 0.05. All analyseswere performed using IBM SPSS Statistics V.21 package.12.5107.57.976.135.00StartWeek 4Week 874 5
practiceFig 3. Mean RESVECH 2.0 scores based on the level of recurrence (a). Scores obtained when patients were grouped as either having anacute or chronic wound (b) and score evolution obtained when patients were grouped following wound severity at baseline (c)abMean RESVECH 2.0 scores15.0c20Chronic woundAcute wound1512.510107.55.020Mean RESVECH 2.0 scoresRecurrence?YesNoMean RESVECH 2.0 scores17.55Baseline RESVECH 2.0score below medianBaseline RESVECH 2.0score above median15105000StartWeek 4Week 8StartWeek 4Week 8exudate control, slough and necrotic tissueelimination, in addition to showing a relevant painand inflammation reduction.On the other hand, when RESVECH 2.0 data wereanalysed based on the recurrence of wounds (Fig 3a), theresults showed no differences between recurrent andnon-recurrent wounds, since both wounds appeared toStartWeek 4Week 8respond to treatment in the same manner. In addition,when RESVECH 2.0 scores of acute wounds were plottedagainst chronic wounds (Fig 3b), a significant reductionin scores in all types of wounds was observed (p 0.001).Also, a statistically significant difference between bothtypes of wounds (acute versus chronic) was observed(p 0.001) and especially noticeable after week 4, probablyFig 4. Case 1, a 67-year-old patient treated with the antioxidant dressing for a traumatic wound measuring 62cm2 andhad a volume of approximately 23ml. Complete wound closure was achieved. Before treatment (a), at weeks 1 (b), 3 (c),5 (d), 8 (e) and 9 (f)bBefore treatmentdWeek 1eWeek 574 6cWeek 3fWeek 8JOURNAL OF WOUND CAREWeek 9VOL 26, NO 12, DECEMBER 2017 2017 MA Healthcare ltda
practiceFig 5. Case 2, a 56-year-old patient with a 6-month dehisced wound measuring around 30cm2. Wound closure wasachieved at week 8. Before treatment (a), at weeks 1 (b), 2 (c), 4 (d), 8 (e) and 9 (f)abBefore treatmentcWeek 1dWeek 2eWeek 4fWeek 8due to the high number of wounds healed in the acutegroup before 8 weeks. When taking into account theseverity of wounds according to baseline RESVECH 2.0scores below or above the median value (Fig 3c), therewere no differences between curves and both types ofwounds appeared to respond in the same manner.The following case studies demonstrated good resultsin the treatment of traumatic wounds (5 of 31 patients),even though all patients with this type of woundpresented other important comorbidities, such asdiabetes, hypertension or vascular disease.Week 9Case 1Fig 4 shows a 67-year-old patient with ischaemiccardiomyopathy, chronic obstructive pulmonarydisease (COPD), saphenectomy and coronaryrevascularisation, who was treated with the antioxidantdressing for a traumatic wound (62cm 2 andapproximately 23ml). The promotion of granulationtissue formation at the beginning of the treatmentreduced the wound’s depth by 80% within 1 week,from 23ml to 4.8ml (Fig 4b). The antioxidant dressingalso allowed proper epithelialisation of the wound andFig 6. Case 3: an 80-year-old patient with a calciphylaxis ulcer. Complete wound closure was achieved. Before treatment (a), at weeks 1 (b),3(c), 4 (d), and 6 (e) 2017 MA Healthcare ltdcbaBefore treatmentJOURNAL OF WOUND CAREWeek 1VOL 26, NO 12, DECEMBER 2017edWeek 3Week 4Week 674 7
practiceFig 7. Case 4: a 73-year-old patient with a deep, 16-month chronic venousleg ulcer (VLU) located on the outer ankle. Good evolution towards closurewere seen at week 7. Before treatment (a), at weeks 1 (b), 5 (c), and 7 (d)baBefore treatmentWeek 1dcwas observed (Fig 7b). Good evolution towards closurewere seen at week 7 (Fig 7d). However, healing in thisand similar cases progressed, in general, slower than inother cases. It is worthwhile noting that most patientsin the VLU group presented very old wounds (up to 360months) with previous recurrent infections andimportant concomitant diseases, and that 30% of thesewounds were located on the outer ankle (7 of a total of20 ulcers).Overall, the antioxidant dressing helped achievecomplete healing or significant improvement at theend of the study in all wounds, regardless of theiraetiology, stage or duration. In addition, the dressingdemonstrated, in both acute and chronic cases, amarked autolytic debridement action that removedslough and necrotic tissue, leaving a clean and healthywound bed. Levels of exudate were well controlled, sothat neither maceration signs nor drying effects wereobserved. The assessment of the product by patientsand professionals was very good in all aspects evaluated,and no adverse events or side effects were reported.Week 7preservation of periwound tissue. Complete woundclosure was achieved.Case 2Similar results were observed in a 56-year-old patientwith multiple comorbidities (diabetes, hypertension,nephropathy, chronic renal failure and obesity) and a6-month dehisced wound (Fig 5). The wound wassurgically debrided before applying the antioxidantdressing. The use of the dressing avoided sloughformation and no maceration was observed. A decreasein oedema and exudate was also observed. The patientexpressed pain relief after the antioxidant dressing wasfirst applied and throughout the wound healingprogress. Despite its large size (around 30cm2), woundclosure was achieved at week 8 (Fig 5e).Case 3An interesting case of calciphylaxis ulcer in an 80-yearold patient with chronic kidney disease undergoingdialysis treatment was also observed (Fig 6). Aftertreatment with the antioxidant dressing, a rapidevolution of the wound from the first dressing changewas observed. The potent debridement effect of theantioxidant dressing eliminated all necrotic tissuefrom the wound. Healthy wound bed tissue andgranulation tissue was observed. Complete
from hard-to-heal wounds. All wounds were located on lower limbs, as per the study’s inclusion criteria. The wounds’ characteristics are listed in Table 3. Overall, 31 wounds were treated with a mean dressing change every 3 days. During the 8-week follow-up, nine
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Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. Crawford M., Marsh D. The driving force : food in human evolution and the future.
Le genou de Lucy. Odile Jacob. 1999. Coppens Y. Pré-textes. L’homme préhistorique en morceaux. Eds Odile Jacob. 2011. Costentin J., Delaveau P. Café, thé, chocolat, les bons effets sur le cerveau et pour le corps. Editions Odile Jacob. 2010. 3 Crawford M., Marsh D. The driving force : food in human evolution and the future.
