Prevention of postoperative wound infections by covering the surgical field with iodine-impregnated incision drape (Ioban<Superscript>®</Superscript> 2)

dgkh000151 10.3205/dgkh000151 urn:nbn:de:0183-dgkh0001510 Review Article Übersichtsarbeit Prevention of postoperative wound infections by covering the surgical field with iodine-impregnated incision drape (Ioban<Superscript>®</Superscript> 2) Prävention postoperativer Wundinfektionen durch Abkleben des OP-Felds mit Iod-imprägnierter Inzisionsfolie (Ioban® 2) Kramer Kramer Axel A Prof. Dr. med.

Institute for Hygiene and Environmental Medicine, Ernst-Moritz-Arndt University, Walther-Rathenau-Straße 49a, 17489 Greifswald, GermanyInstitute for Hygiene and Environmental Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany

Institut für Hygiene und Umweltmedizin, Ernst-Moritz-Arndt-Universität Greifswald, Walther-Rathenau-Straße 49a, 17489 Greifswald, DeutschlandInstitut für Hygiene und Umweltmedizin, Ernst-Moritz-Arndt-Universität Greifswald, Deutschland

kramer@uni-greifswald.de author Assadian Assadian Ojan O

Institute for Hygiene and Environmental Medicine, Ernst-Moritz-Arndt University, Greifswald, Germany

Institut für Hygiene und Umweltmedizin, Ernst-Moritz-Arndt-Universität Greifswald, Deutschland

author Lademann Lademann Jürgen J

Centre for Applied Skin Physiology, Clinic for Dermatology, Venerology and Allergology, Charité – University Medicine Berlin, Campus Mitte, Berlin, Germany

Zentrum für Angewandte Hautphysiologie, Klinik für Dermatologie, Venerologie und Allergologie, Charité – Universitätsmedizin Berlin, Campus Mitte, Berlin, Deutschland

author German Medical Science

Düsseldorf, Köln

610 iodine-impregnated incision drape Ioban 2 microbicidal activity antiseptic efficacy SSI rate biocompatibility Iod-imprägnierte OP-Folie Ioban 2 mikrobiozide Wirksamkeit antiseptische Wirkung SSI Rate Biokompatibilität 20100921 engl germ 1863-5245 5 2 GMS Krankenhaushygiene Interdisziplinär GMS Krankenhaushyg Interdiszip 08 Anhand des Schrifttums wird die Bedeutung des Einsatzes von Iod-imprägnierter Inzisionsfolie (Ioban® 2) für die Prävention postoperativen Wundinfektionen (SSI) analysiert. Die Folie zeigt in in vitro eine mikrobiozide Wirksamkeit. Demzufolge kommt es auch bei Anwendung auf der Haut zu einer antiseptischen Wirkung unter der Inzisionsfolie, zugleich wird die bakterielle Wundkontamination verringert. Insgesamt ist auf Grund der Effektstärke der antiseptischen Inzisionsfolie eine Reduzierung der SSI-Rate allerdings nur bei großem Stichprobenumfang zu sichern. In einer Meta-Analyse mit Auswertung von vier prospektiven und einer retrospektiven Studie konnte die Herabsetzung der SSI-Rate signifikant gesichert werden. Bezüglich der Biokompatibilität der Iod-imprägnierten Inzisionsfolie gibt es keine Einschränkungen. The literature is used to analyse the significance of the use of iodine-impregnated incision drape (Ioban® 2) for the prevention of postoperative wound infections (SSI). The drape has a microbiocidal effect in vitro. Consequently an antiseptic effect also occurs under the incision drape when it is applied to the skin; at the same time, bacterial wound contamination is reduced. Overall, based on the efficacy strength of the antiseptic incision drape, a reduction of the SSI rate can, however, be confirmed only with a large sample size. A meta analysis which evaluated four prospective studies and one retrospective study was able to provide significant confirmation of a reduction in the SSI rate. There are no limitations in terms of the biocompatibility of the iodine-impregnated incision drape. IntroductionMost postoperative wound infections (SSI) result from endogenic conditions. Therefore the prevention of bacterial contamination in the region of the surgical incision is an important task. After preoperative skin antiseptics, an average of 1 log CFU (i.e. one 10x potency of microorganisms) remains on the skin. This consists of the resident skin flora, with S. epidermidis in the foreground. From the remaining skin flora, pathogens can intraoperatively enter the surgical wound and become causative factors of SSI. The localisation of a large part of the bacteria in the hair follicles , in which – due to anatomical conditions – they are only incompletely reached by the alcoholic skin antiseptics, is to be regarded as a significant cause of the restricted efficacy of skin antiseptics. Since iodine has good penetration abilities, it can be assumed that it also penetrates the hair follicles and the bacteria which are located there are at least partly reached.In addition to skin antiseptics, the use of antimicrobially impregnated incision drapes and skin sealing , , with the purpose of killing pathogens which have floated up or suppressing their upward movement out of the follicles provide options to minimise the potential dangers of this reservoir of pathogens. Around the incision one can reduce the level of SSI trough the use of antiseptic impregnated sutures , , , , , . For future applications it appears promising to introduce into the practice liposomal products for skin antiseptics which penetrate the hair follicles and exercise an antiseptic effect there .The following overview will evaluate the literature on the efficacy of iodine-impregnated incision drapes in order to assess their value in the prevention of SSI. EinleitungDie meisten postoperativen Wundinfektionen (SSI) entstehen endogen. Daher ist die Verhütung der bakteriellen Kontamination im Bereich der chirurgischen Inzision eine wichtige Aufgabenstellung. Nach präoperativer Hautantiseptik verbleiben durchschnittlich 1 log KbE (also eine Zehnerpotenz Mikroorganismen) auf der Haut. Hierbei handelt es sich um die residente Hautflora mit S. epidermidis im Vordergrund. Von der verbleibenden Hautflora können Erreger intraoperativ in die OP-Wunde gelangen und Ursache von SSI werden. Als wesentliche Ursache für die eingeschränkte Wirksamkeit der Hautantiseptik ist die Lokalisation eines Großteils der Bakterien in den Haarfollikeln anzusehen , in denen sie anatomisch bedingt von den alkoholischen Hautantiseptika nur unvollständig erreicht werden. Da Iod über gute Penetrationseigenschaften verfügt, ist anzunehmen, dass es auch in die Haarfollikel eindringt und dort die Bakterien zumindest zum Teil erfasst werden.Zur Minimierung der potentiellen Gefahr dieses Erregerreservoirs bieten sich zusätzlich zur Hautantiseptik der Einsatz antimikrobiell imprägnierter Inzisionsfolien und die Hautversiegelung , , mit dem Zweck an, hoch geschwemmte Erreger abzutöten oder deren Ausschwemmung aus den Follikeln zu unterdrücken. Im Bereich der Wundnaht ist durch Einsatz antiseptisch imprägnierten Nahtmaterials eine Reduktion von SSI erreichbar , , , , , . Perspektivisch erscheint es aussichtsreich, liposomale Zubereitungen zur Hautantiseptik in die Praxis einzuführen, die in die Haarfollikel eindringen und dort antiseptisch wirksam werden .In der nachfolgenden Übersicht soll das Schrifttum zur Wirksamkeit von Iod-imprägnierten Inzisionsfolien ausgewertet werden, um deren Stellenwert zur Prävention von SSI beurteilen zu können. Microbiocidal efficacy in vitroIn accordance with ASTM E2315-0 , the coated side of the iodine-impregnated incision drape was contaminated. After 30, 60 and 90 min, the test organisms (MRSA, S. epidermidis, E. faecalis (VRE), E. faecium (MDR), S. pyogenes, E. cloacae, E. coli, K. pneumoniae, P. aeruginosa, S. marcescens, C. albicans, C. parapsilosis) were washed off in neutralisation solution, and the reduction factor (RF) was determined . For comparison, two further drapes without antiseptic impregnation were tested. While the control drapes were ineffective, the iodine-impregnated incision drape obtained a reduction by up to 1 log after 30 min, depending on the species. After 60 min, the reduction as compared to MRSA was slightly more than 2 log; it amounted to approximately 3.5 log as compared to MRSE. After 90 min, the RF against both species exceeded 5 log. The RF differed between 1 and >6 log as compared to the other test organisms. The efficacy of the antiseptic drape was directed primarily against staphylococci, i.e. the main target of preoperative skin antiseptics.ConclusionAfter direct inoculation onto the iodine impregnated incision drape it shows a clinically relevant reduction of the microbial count. Mikrobiozide Wirksamkeit in vitroGemäß ASTM E2315-0 wurden die beschichtete Seite der Iod-imprägnierten Inzisionsfolie kontaminiert, nach 30, 60 and 90 min die Testorganismen (MRSA, S. epidermidis, E. faecalis (VRE), E. faecium (MDR), S. pyogenes, E. cloacae, E. coli, K. pneumoniae, P. aeruginosa, S. marcescens, C. albicans, C. parapsilosis) in Neutralisationslösung abgeschwemmt und der Reduktionsfaktor (RF) bestimmt . Zum Vergleich wurden zwei weitere Folien ohne antiseptische Imprägnierung getestet. Während die Kontrollfolien unwirksam waren, wurde durch die Iod-imprägnierte Inzisionsfolie speciesabhängig nach 30 min eine Reduktion um bis zu 1 log erreicht. Nach 60 min</PlainText></TextGroup> betrug die Reduktion gegenüber MRSA etwas über 2 log, gegenüber MRSE etwa 3,5 log. Nach 90 min übertraf der RF gegen beide Species 5 log. Gegenüber den übrigen Testorganismen differierte der RF zwischen 1 und >6 log. Die Wirksamkeit der antiseptischen Folie richtete sich bevorzugt gegen Stapylokokken, also das Haupttarget der präoperativen Hautantiseptik.</Pgraph><SubHeadline>Schlussfolgerung</SubHeadline><Pgraph>Nach direkter Beimpfung der Iod-imprägnierten Inzisionsfolie zeigt diese nach 1 h eine klinisch relevante Reduzierung der Keimzahldichte.</Pgraph></TextBlock> <TextBlock language="en" linked="yes" name="Effects on the skin flora and wound contamination"> <MainHeadline>Effects on the skin flora and wound contamination</MainHeadline><Pgraph>When comparing the efficacy of skin antiseptics with PVP iodine to the use of the iodine-impregnated drape without preceding skin antiseptics, the skin antiseptics with PVP iodine were more effective than the drape, though the drape also had an antiseptic effect. At the same time, the iodine-impregnated drape reduced wound contamination <TextLink reference="15"></TextLink>. Analogous results were shown by the comparison between preoperative antiseptics with PVP iodine/alcohol (betadine), identical antiseptics with subsequent use of the antiseptic incision drape and use of the drape alone <TextLink reference="16"></TextLink>. </Pgraph><Pgraph>In a comparison of the skin flora at the end of surgery after skin antiseptics with PVP iodine (n=107) and after the use of the iodine-impregnated incision drape 24 h before the start of surgery to the end of surgery (n=122), the wound contamination rate was 15% and 1.6% respectively <TextLink reference="17"></TextLink>.</Pgraph><SubHeadline>Conclusion</SubHeadline><Pgraph>The iodine-impregnated drape does not only significantly reduce the resident skin flora, but its use also clearly reduces intraoperative wound contamination. </Pgraph></TextBlock> <TextBlock language="de" linked="yes" name="Wirkung auf die Hautflora und auf die Wundkontamination"> <MainHeadline>Wirkung auf die Hautflora und auf die Wundkontamination</MainHeadline><Pgraph>Beim Vergleich der Wirksamkeit einer Hautantiseptik mit PVP-Iod mit Anwendung der Iod-imprägnierten Folie ohne vorherige Hautantiseptik war die Hautantiseptik mit PVP-Iod zwar wirksamer als die Folie, aber auch die Folie entfaltete eine antiseptische Wirksamkeit. Zugleich wurde die Wundkontamination durch die Iod-imprägnierte Folie reduziert <TextLink reference="15"></TextLink>. Ein analoges Ergebnis erbrachte der Vergleich zwischen präoperativer Antiseptik mit PVP-Iod/Alkohol (Betadine), identischer Antiseptik mit nachfolgender Anwendung der antiseptischen Inzisionsfolie und alleiniger Anwendung der Folie <TextLink reference="16"></TextLink>. </Pgraph><Pgraph>Bei einem Vergleich der Hautflora am OP-Ende nach Hautantiseptik mit PVP-Iod (n=107) bzw. nach Anwendung der Iod-imprägnierten Inzisionsfolie 24 h vor OP-Beginn bis zum OP-Ende (n=122) betrug die Wundkontaminationsrate 15% bzw. 1,6% <TextLink reference="17"></TextLink>.</Pgraph><SubHeadline>Schlussfolgerung</SubHeadline><Pgraph>Die Iod-imprägnierte Folie reduziert nicht nur die residente Hautflora signifikant, durch ihre Anwendung wird auch die intraoperative Wundkontamination deutlich herabgesetzt. </Pgraph></TextBlock> <TextBlock language="en" linked="yes" name="Influence on the SSI rate"> <MainHeadline>Influence on the SSI rate</MainHeadline><SubHeadline>Retrospective studies</SubHeadline><Pgraph>After the removal of liver cancers, the influence of the iodine-impregnated drape on the SSI rate was compared to skin antiseptics without using the drape (n=296). The SSIs were defined as purulent drainage from superficial incisions with or without laboratory confirmation and one or more of the following symptoms: pain, local swelling, redness, heat. SSIs occurred in 25 patients. The regression analysis showed that risk factors consisted of low BMI, smoking, long preoperative hospital stays and no use of the antiseptic drape. Using a multivariant regression analysis, the BMI, smoking and no use of the antiseptic drape were independent risk factors. The SSI rate with use of the antiseptic drape was 3.1%; without use of the adhesive drape, it was 12.1%. Based on the sample size, the difference was not significant <TextLink reference="18"></TextLink>. </Pgraph><Pgraph>In hip endoprosthesis implantations, no significant influence on the SSI rate was found after the use of the antiseptic drape (n=649) as compared to use of skin antiseptics alone with PVP iodine <TextLink reference="19"></TextLink>.</Pgraph><SubHeadline>Prospective randomised controlled studies</SubHeadline><Pgraph>In a comparison of preoperative skin antiseptics for <TextGroup><PlainText>1 min</PlainText></TextGroup> with 70% ethanol or 2% iodine in 90% ethanol and subsequent application of the antiseptic drape vs. <TextGroup><PlainText>10 min</PlainText></TextGroup> of skin antiseptics with iodophor without drape, the SSI rate did not show a difference (in clean interventions, 1.3% vs. 1.3%; in a comparison of all interventions, 2.5% vs. 2.3%, n=1,324) <TextLink reference="20"></TextLink>. </Pgraph><Pgraph>The use of the antiseptic drape in comparison to standard skin antiseptics without using the drape (n=1,102) did reduce wound contamination in abdominal and cardiac surgery; however the SSI rate did not differ significantly <TextLink reference="15"></TextLink>.</Pgraph><Pgraph>In cardiac surgery, the use of the antiseptic drape also showed only a tendential reduction in the rate of SSIs (6.3% vs. 14.8%) <TextLink reference="21"></TextLink>. </Pgraph><Pgraph>No SSI occurred in 616 patients after fusing of the frontal cervical vertebrae without using the antiseptic drape. This led to the conclusion that the use of antiseptic drape is dispensable for this intervention <TextLink reference="22"></TextLink>. </Pgraph><SubHeadline>Meta analyses</SubHeadline><Pgraph>The scope of a Cochrane analysis comparing iodine-impregnated incision drape vs. no incision drape, no significant difference in the rate of SSIs was shown in an evalu-ation of 2 studies with 1,113 patients <TextLink reference="23"></TextLink>.</Pgraph><Pgraph>Parks <TextLink reference="2"></TextLink> calculated that a sample size of at least 10,000 is required in order to confirm the efficacy of iodine-impregnated incision drape due to the low rate of SSI in clean and clean-contaminated surgery. In the evaluation of SSI rates (clean or clean-contaminated cardiovascular and abdominal interventions and liver resection) of four prospective studies and one retrospective study with the Mantel-Haenszel-Cochrane (MHC) statistics, he calculated an OR of 0.34 with a lower confidence interval 95% of 0.222 and an upper confidence interval of 0.702; i.e. the reduction of the SSI rate through the use of iodine-impregnated incision drape was significant.</Pgraph><SubHeadline>Conclusion </SubHeadline><Pgraph>The use of iodine-impregnated incision drape as compared to the use of incision drape with no antiseptic impregnation was not associated with negative consequences in any of the studies. Overall, based on the efficacy strength of the antiseptic incision drape, a reduction of the SSI rate can, however, be confirmed only with a large sample size. From a surgical perspective, the indication range for iodine-impregnated incision drape can therefore not be precisely defined at this time.</Pgraph></TextBlock> <TextBlock language="de" linked="yes" name="Einfluss auf die SSI-Rate"> <MainHeadline>Einfluss auf die SSI-Rate</MainHeadline><SubHeadline>Retrospektive Studien</SubHeadline><Pgraph>Nach Lebercarcinomresektion wurde der Einfluss der Iod-imprägnierten Folie auf die SSI-Rate mit Hautantiseptik ohne Folienanwendung verglichen (n=296). Die SSI waren definiert als purulente Drainage aus oberflächlicher Inzision mit oder ohne Laborbestätigung + ein oder mehrere der folgenden Symptome: Schmerz, lokale Schwellung Rötung, Erwärmung. Bei 25 Patienten trat eine SSI auf. Die Regressionsanalyse ergab als Risikofaktoren geringer BMI, Rauchen, langer präoperativer Krankenhausaufenthalt und keine Verwendung der antiseptischen Folie. Mittels multivariater Regressionsanalyse waren BMI, Rauchen und keine Verwendung der antiseptischen Folie unabhängige Risikofaktoren. Bei Verwendung der antiseptischen Folie war die SSI-Rate 3,1%, ohne Einsatz der Klebefolie 12,1%. Auf Grund der Stichprobengröße war der Unterschied nicht signifikant <TextLink reference="18"></TextLink>. </Pgraph><Pgraph>Bei Hüftendoprothesenimplantation war nach Anwendung antiseptischer Folie kein signifikanter Einfluss auf die SSI-Rate (n=649) im Vergleich zu alleiniger Hautantiseptik mit PVP-Iod feststellbar <TextLink reference="19"></TextLink>.</Pgraph><SubHeadline>Prospektive randomisierte kontrollierte Studien</SubHeadline><Pgraph>Beim Vergleich präoperative Hautantiseptik für 1 min mit 70% Ethanol oder 2% Iod in 90% Ethanol und anschließende Anwendung der antiseptischen Folie vs. 10 min Hautantiseptik mit Iodophor ohne Folie unterschied sich die SSI-Rate nicht (bei sauberen Eingriffen 1,3% vs. 1,3%, beim Vergleich aller Eingriffe 2,5% vs. 2,3%, n=1.324) <TextLink reference="20"></TextLink>. </Pgraph><Pgraph>Durch die Anwendung der antiseptischen Folie im Vergleich zur Standard-Hautantiseptik ohne Folienanwendung (n=1.102) wurde in der Abdominal- und Herzchirurgie zwar die Wundkontamination reduziert, die SSI-Rate unterschied sich jedoch nicht signifikant <TextLink reference="15"></TextLink>.</Pgraph><Pgraph>In der Herzchirurgie wurde durch Einsatz der antiseptischen Folie die SSI-Rate ebenfalls nur tendenziell reduziert (6,3% vs. 14,8%) <TextLink reference="21"></TextLink>. </Pgraph><Pgraph>Nach Verblockung der vorderen Halswirbel trat bei 616 Patienten ohne Anwendung von antiseptischer Folie keine SSI auf. Daraus wurde die Schlussfolgerung abgeleitet, dass der Einsatz antiseptischer Folie für diesen Eingriff entbehrlich ist <TextLink reference="22"></TextLink>. </Pgraph><SubHeadline>Meta-Analysen</SubHeadline><Pgraph>Im Rahmen einer Cochrane-Analyse Iod-imprägnierter Inzisionsfolien vs. keine Inzisionsfolien ergab sich bei der Auswertung von 2 Studien mit 1.113 Patienten kein signifikanter Unterschied in der SSI Rate <TextLink reference="23"></TextLink>.</Pgraph><Pgraph>Parks <TextLink reference="2"></TextLink> hat kalkuliert, dass zum Nachweis der Effektivität Iod-imprägnierter Inzisionsfolie wegen der allgemein geringen Infektionsraten in sauber und sauber-kontaminierten Eingriffen eine Stichprobengröße von mindestens 10.000 erforderlich ist. Bei der Auswertung der SSI-Raten (saubere oder sauber-kontaminierte kardiovaskuläre und abdominale Eingriffe bzw. Leberresektion) von 4 prospektiven und einer retrospektiven Studie mit der Mantel-Haenszel-Cochrane (MHC) Statistik hat er eine OR von 0,34 mit unterem CI 95% von 0,222 und oberem CI von 0,702 errechnet, d.h. die Verringerung der SSI-Rate durch die Anwendung Iod-imprägnierter Inzisionsfolie war signifikant.</Pgraph><SubHeadline>Schlussfolgerung </SubHeadline><Pgraph>In keiner Studie war der Einsatz Iod-imprägnierter Inzisionsfolie im Unterschied zur Verwendung nicht antiseptisch imprägnierter Inzisionsfolie mit negativen Folgen verbunden. Insgesamt ist auf Grund der Effektstärke der antiseptischen Inzisionsfolie eine Reduzierung der SSI-Rate jedoch nur bei großem Stichprobenumfang zu sichern. Aus chirurgischer Sicht ist der Indikationsbereich für Iod-imprägnierte Inzisionsfolie daher derzeit nicht genau zu definieren.</Pgraph></TextBlock> <TextBlock language="en" linked="yes" name="Biocompatibility"> <MainHeadline>Biocompatibility</MainHeadline><Pgraph>In experimental wounds in rats, 2% PVP iodine did not have any influence on wound healing, while 5% already inhibited wound healing <TextLink reference="24"></TextLink>. Therefore no negative influence on wound healing is to be feared due to the utilised concentration of 2% in the antiseptic drape.</Pgraph><Pgraph>Furthermore, the use of the iodine-impregnated incision drape does not mean that a risk to the thyroid gland must be expected [in preparation].</Pgraph></TextBlock> <TextBlock language="de" linked="yes" name="Biokompatibilität"> <MainHeadline>Biokompatibilität</MainHeadline><Pgraph>An experimentellen Wunden bei Ratten war 2% PVP-Iod ohne Einfluss auf die Wundheilung, während die Wundheilung durch 5% bereits gehemmt wurde <TextLink reference="24"></TextLink>. 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