N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

Jodium

PICO

P Laparotomie (CDC klasse II schoon-besmet)

I Chloorhexidine als pre-operatief antisepticum

C Jodium

O Post-operatieve wondinfectie

N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

PICO

1. Schoon: primair gesloten, niet 2/3/4

2. Schoon-besmet: respiratoir/gastro-intestinaal/urogenitaal

3. Besmet: trauma, inflammatie, niet steriel of GI-lekkage

4. Verontreinigd/geïnfecteerd: oude traumatische wond of orgaanperforatie met niet-vitaal weefsel

PICO

Chloorhexidine:2% in 70% alcohol Bindt CH-kation aan negatief geladen celmembraan Direct optimaal effect

Jodium: Povidonjodium 10% in water [Betadine] Oxideert thiol-groep, eiwitstructuur en functie Optimaal effect na 3min drogen Huidirritatie met 0,7% sensitisatie

Zoekstrategie

NCBI: Pubmed Cochrane [26-01-2015]

Iodine [Mesh]Chlorhexidine [Mesh]RCT & (Syst) Review ≥ 01-01-2005

Uitgebreidere omschrijving zoekopdracht aan einde van powerpoint N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

Opbrengst zoekstrategie

Noorani et al., (2010) Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg.;97(11):1614-20

Lee et al., (2010) Systematic review and cost analysis comparing use of chlorhexidine with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control Hosp Epidemiol. ;31(12):1219-29

Totale zoekopbrengst aan einde van powerpoint N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

Opbrengst zoekstrategie

Noorani et al., (2010)

6 studies, n = 5031

Clinical trials, wondinfectie als uitkomstCDC Klasse II excl. oropharyngeal

Twee reviewersOxford quality scoring system (Jadad)

Noorani et al., 2010

n totaal = 5031

Noorani et al., 2010

1. Darouiche et al., (2010) Chlorhexidine–alcohol versus povidone–iodine for surgical-site antisepsis.

2. Paocharoen et al., (2009) Comparison of surgical wound infection after preoperative skin preparation with 4 per cent chlorhexidine and povidone iodine: a prospective randomized trial.

3. Swenson et al., (2009) Effects of preoperative skin preparation on postoperative wound infection rates: a prospective study of 3 skin preparation protocols.

4. Culligan et al., (2005) A randomised trial that compared povidone–iodine and chlorhexidine as antiseptics for vaginal hysterectomy.

5. Berry et al., (1982) A comparison of the use of povidone–iodine and chlorhexidine in the prophylaxis of postoperative wound infection.

6. Brown et al., (1984): A clinical evaluation of chlorhexidine gluconate spray as compared with iodophor scrub for preoperative skin preparation.

Noorani et al., 2010

Studie Vergelijking Excl. Uitkomst JADAD

Darouiche 2010

(10%) PVI vs 2% CH in 70% IA <18jr, Allergie

SSI, sepsis RCT 3

Paocharoen 2009

PVI vs 4% CH SSI RCT 1

Swenson 2009

PVI vs 2% CH vs iodine povacrylex

SSI Pros 0

Culligan 2005

PVI vs 4% CH CFU RCT 2

Berry 1982

PVI vs 0,5% CH Infectie RCT 0

Brown1984

PVI scrub vs 0,5% CH spray SSI RCT 2

Noorani et al., 2010

Chloorhexidine vermindert het aantal post-operatieve wondinfecties vergeleken met povidonjodium. RR 0·68 [95% BI, 0·50 - 0·94]

Lee et al., 2010

Lee et al., (2010)

9 studies, totaal aantal patiënten = 3614

RCT’s, wondinfectie en positieve huidkweek als uitkomstAlle soorten chirurgische ingrepen excl. chlorhexidine douche, bad of mondspoeling als interventie

Oxford quality scoring system (Jadad)

Kosten-baten analyse

Lee et al., 2010

n totaal SSI = 3437n totaal pos kweek = 827

Lee et al., 2010

Chloorhexidine vermindert het aantal post-operatieve wondinfecties vergeleken met povidonjodium. RR 0·64 [95% BI, 0·51 - 0·90]

Lee et al., 2010

Chloorhexidine vermindert het aantal positieve huidflora-kweken vergeleken met povidonjodium. RR 0·44 [95% BI, 0·35 - 0·56]

Culligan et al., 2005

n=50Afname sample vaginale flora pre-desinfectieAfname sample post-desinfectie 1x na 30min 1x /60min

Kweek positief bij ≥5000 CFU/ml

Culligan et al., 2005

Povidonjodium: 17/27 kweken positief (63%)Chloorhexidine: 5/23 kweken positief (22%) P = 0·003

Bewijskracht

A1

A2

Bewijsniveau in Nederlandse CBO Richtlijnen

Systematische reviews (meta-analyse) die tenminste enkele onderzoeken van A2-niveau betreffen, waarbij de resultaten van de afzonderlijke onderzoeken consistent zijn.

Gerandomiseerd vergelijkend klinisch onderzoek van goede kwaliteit van voldoende omvang en consistentie.

1

Niveau van de conclusie op basis van de literatuuranalyse

Gebaseerd op 1 systematische review (A1) of tenminste 2 onafhankelijk van elkaar uitgevoerde onderzoeken van niveau A2

Critical appraisal

A. Toepasbaarheid Noorani LeePast mijn patiënt in de patiëntengroep waarover in het artikel gerapporteerd wordt?

Ja

Is de interventie die bestudeerd wordt vergelijkbaar met de interventie die ik wil uitvoeren?

Ja

Is de uitkomst of effectmaat waarover gerapporteerd wordt van belang voor mijn patiënt?

Ja

Critical appraisal

B. Validiteit Noorani LeeZijn de studies gerandomiseerd? 5/6 9/9Was er sprake van geheimhouding voor randomisatie? ? >1/9Waren de groepen bij start van het onderzoek vergelijkbaar?

Ja Ja

Is van alle patiënten follow-up beschikbaar Ja JaZijn alle gerandomiseerde patiënten geanalyseerd in de groep waarvoor ze gerandomiseerd zijn?

Ja Ja

Is de studie goed geblindeerd met betrekking tot:- Patiënten- Behandelaars- Effectbeoordelaars

JaNee

?

Ja>1/9>1/9

Aanwijzing voor publication bias bij RCT’s? Nee Nee

Conclusie

Het is aangetoond dat bij patiënten die een laparotomie ondergaan (P), chloorhexidine (I) als pre-operatief antisepticum werkzamer is dan jodium (C) in het voorkomen van post-operatieve wondinfecties (O).

Noorani et al., 2010: RR 0·68 [95% BI, 0·50 - 0·94]Lee et a., 2010: RR 0·64 [95% BI, 0·51 - 0·90]

N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

Discussie

Niet specifiek voor gynaecologische OK’s (andere flora vaginaal dan dermaal)

Syst. Reviews: Geen onderscheid in oppervlakkig, diep incisionaal, orgaan en holte

Geen onderscheid in potentiële ernst van positieve kweken

Therapietrouw (mogelijk ten gunste chloorhexidine)

N. Pouw , co-assistent M2 VUmc, n.pouw@student.vu.nl

Vragen?

Vragen?

Darouiche et al., 2010Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH (2010) Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 7;362(1):18-26

Bewijs uit andere hoek…Yamamoto N, Kimura H, Misao H, Matsumoto H, Imafuku Y, Watanabe A, Mori H, Yoshida A, Miura S, Abe Y, Toba M, Suzuki H, Ogawa K, Kanemitsu K. (2014) Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10% povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study. Am J Infect Control.;42(5):574-6

Method: Each CVC was assigned to either CHG-EtOH 79 vol/vol% or 10% PV-I in accordance with a computer-generated randomization list. Multiple CVC enrollment in the study by any single patient was permitted during the study period. For each patient, the CVC insertion site was prepared with CHG-EtOH or PV-I, and allowed to dry for at least 120 seconds. Specimens were collected by swabbing the CVC exit site skin just before weekly sterile film dressing change and cleansing with the respective agent. A commercial sterile cotton swab was circled twice around the CVC exit site and incubated at 35°C overnight on a blood agar plate. Cultured microorganisms were identified by VITEK 2.Blood cultures were taken from the patients within 3 hours of the onset of a fever (body temperature ≥38.0°C), and/or other signs of infection, or inflammation of the CVC exit site. CABSI was diagnosed according to the definitions of the Centers for Disease Control and Prevention National Healthcare Safety Network.5

Bewijs uit andere hoek…Yamamoto N, Kimura H, Misao H, Matsumoto H, Imafuku Y, Watanabe A, Mori H, Yoshida A, Miura S, Abe Y, Toba M, Suzuki H, Ogawa K, Kanemitsu K. (2014) Efficacy of 1.0% chlorhexidine-gluconate ethanol compared with 10% povidone-iodine for long-term central venous catheter care in hematology departments: a prospective study. Am J Infect Control.;42(5):574-6

1% CGH 10% PI RR= p=

CVC colonisatie 11.9% 29.2% 0·41 [95% BI, 0·18-0·90]

0·030

CABSI totaal 3.4% 14.6% 0·23 [95% BI, 0·06 - 0·93]

0·075

CABSI Incidentie dichtheid / 1000 CVC-dagen

0·21 [95% BI, 0·05-0·88]

0·041

Vaginal cleansing with 1% chlorhexidinePereira L, Chipato T, Mashu A, Mushangwe V, Rusakaniko S, Bangdiwala SI, Chidede OS, Darmstadt GL, Gwanzura L, Kandawasvika G, Madzime S, Lumbiganon P, Tolosa JE (2011) Randomized study of vaginal and neonatal cleansing with 1% chlorhexidine. Int J Gynaecol Obstet.;112(3):234-8.

Objective: To determine the safety, acceptability, and antimicrobial effect of 1% chlorhexidine (CHX) vaginal washing of women in labor and their neonates.Methods: Randomized controlled trial of 1% CHX vaginal and neonatal washing compared with no washing (usual care [UC]). The study included 502 women (334 CHX, 168 UC) who delivered 508 liveborn neonates (335 CHX, 173 UC). Main outcome measures were the incidence of maternal adverse effects, the incidence of neonatal skin rash, the axillary temparature before and after neonatal wiping, and vaginal culture results.Results: Maternal demographics did not differ between the groups. No case of maternal rash occured; 4% of women experienced vaginal burning. An axillary temperature drop of more than 1 °C after CHX cleansing occurred in 8 neonates; 2 neonates had a minor rash. In the subset of women with positive vaginal cultures as baseline, 1% CHX eliminated culture growth in 56% after 1 wash, and in 86% after 2 washes.

Conclusions: Use of 1% CHX is safe for neonates, well tolerated by laboring mothers, and effective in treating vaginal infections during labor. A randomized controlled trial using 1% CHX and powered for a reduction in neonatal septic mortality is justified based on these data.

Vaginal chlorhexidine during labour Ohlsson A, Shah VS, Stade BC (2014) Vaginal chlorhexidine during labour to prevent early-onset neonatal group B streptococcal infection. Cochrane Database Syst Rev. doi: 10.1002/14651858.CD003520.pub3.

MAIN RESULTS: Maternal mild side effects (stinging or local irritation) (three trials, 1066 women) were more commonly seen in women treated with chlorhexidine (RR 8.50 (95% CI 1.60 to 45.28).

AUTHORS' CONCLUSIONS: The quality of the four included trials varied as did the risk of bias and the quality of the evidence using GRADE was very low. Vaginal chlorhexidine was not associated with reductions in any of the primary outcomes of early-onset GBS disease (sepsis and/or meningitis) or GBS pneumonia. Vaginal chlorhexidine may reduce GBS colonization of neonates.

Zoekstrategie("Iodine"[MeSH] OR "iodides"[MeSH Terms] OR "Povidone-Iodine"[Mesh]) AND ("chlorhexidine"[Mesh] OR "chlorhexidine gluconate"[Supplementary Concept] OR "chlorhexidine gluconate, lidocaine drug combination"[Supplementary Concept] OR "Hydrex"[Supplementary Concept] OR "Anticataracticum"[Supplementary Concept]) AND ((Randomized Controlled Trial[ptyp] OR systematic[sb] OR Review[ptyp]) AND "2005/01/01"[PDat] : "2015/01/26"[PDat])

Iodine[Title/Abstract] AND Chlorhexidine[Title/Abstract] AND (systematic[sb] AND "2010/01/01"[PDat] : "2015/01/26"[PDat])

Complete opbrengst zoekstrategieNoorani A, Rabey N, Walsh SR, Davies RJ (2010) Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20

Lee I, Agarwal RK, Lee BY, Fishman NO, Umscheid CA (2010) Systematic review and cost analysis comparing use of chlorhexidine with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control Hosp Epidemiol. ;31(12):1219-29

Jarral OA, McCormack DJ, Ibrahim S, Shipolini AR (2011) Should surgeons scrub with chlorhexidine or iodine prior to surgery? Interact Cardiovasc Thorac Surg. ;12(6):1017-21

Hadiati DR, Hakimi M, Nurdiati DS (2014) Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2014 Sep 17;9 [Low-graded evidence]

Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A. (2013) Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 28;3

American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. (2013) Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. ;122(3):718-20.

Scowcroft T. (2012) A critical review of the literature regarding the use of povidone iodine chlorhexidine gluconate for preoperative surgical skin preparation. J Perioper Pract. ;22(3):95-9. Review. [volledig artikel niet beschikbaar]

Overige referentiesSrinivas A, Kaman L, Raj P, Gautam V, Dahiya D, Singh G, Singh R, Medhi B. Comparison of the efficacy of chlorhexidine gluconate versus povidone iodine as preoperative skin preparation for the prevention of surgical site infections in clean-contaminated upper abdominal surgeries. Surg Today. 2014 Nov 9

Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S (2002) Chlorhexidine compared with povidone-iodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med.;136(11):792-801.

CDC/NHSN (2015) Surveillance Definitions for Specific Types of Infections. http://www.cdc.gov/nhsn/PDFs/pscManual/17pscNosInfDef_current.pdf (accessed 27-01-’15)

HICPACCenters for Disease Controle and Prevention (1999) Guideline for Prevention of Surgical Site Infection

Class I/Clean:

An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, clean wounds are primarily closed and, if necessary, drained with closed drainage. Operative incisional wounds that follow nonpenetrating (blunt) trauma should be included in this category if they meet the criteria.

Class II/Clean-Contaminated:

An operative wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of infection or major break in technique is encountered.

Class III/Contaminated:

Open, fresh, accidental wounds. In addition, operations with major breaks in sterile technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered are included in this category.

Class IV/Dirty-Infected

Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforatedviscera. This definition suggests that the organisms causing postoperative infection were present in the operative field before the operation.

JADAD

Bewijskracht

1 gebaseerd op een systematische review (A1) of ten minste twee onafhankelijk van elkaar uitgevoerde onderzoeken van niveau A2

2 gebaseerd op ten minste twee onafhankelijk van elkaar uitgevoerde onderzoeken van niveau B

3 gebaseerd op een onderzoek van niveau A2 of B, of op onderzoek van niveau C

4 mening van deskundigen, bijvoorbeeld de werkgroepleden

A1 systematische reviews (meta-analyse) A2 gerandomiseerd vergelijkend onderzoek B gerandomiseerd vergelijkend onderzoek van matige kwaliteit of

onvoldoende omvang C niet vergelijkend onderzoek D mening van deskundigen