Povidone Iodine Irrigation

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Surgical site infection is an infre-quent but serious complication ofsurgery.1 Postoperative infection of-ten requires repeat surgery and pro-longed hospitalization, and it maycompromise ultimate surgical out-comes.1 In addition to sterile proce-

dures and patient warming, prophy-lactic antibiotics have been shown toreduce surgical site infection.1,2 De-spite the widespread use of prophy-lactic antibiotics, however, surgicalsite infection continues to occur andis devastating for patients.1 Many dif-

ferent wound irrigation solutions, in-cluding soaps, antibiotics and anti-septics, have been used to reducesurgical site infection.3,4 Wound irri-gation with povidone-iodine, an an-tiseptic solution, may be useful forreducing infection, but it is of uncer-

tain efficacy and risk.Povidone-iodine (Betadine) is anantiseptic solution consisting of poly-vinylpyrrolidone with water, iodideand 1% available iodine; it has bacteri-cidal ability against a large array ofpathogens.5 Although a vast amount

of literature exists regarding its use as atopical antibacterical agent in surgery,its use as a prophylactic irrigation solu-tion against surgical site infection hasbeen examined to a lesser degree. Thisevidence-based review sought to de-termine the efficacy and risks of using

povidone-iodine irrigation to preventsurgical site infection.

Methods

We conducted a search of MED-LINE (19662006) and EMBASE

Accepted for publication Apr. 30, 2007

Correspondence to:Josie Chundamala, The Hospital for Sick Children, Department of Surgery, 555 University Ave., Rm. 1218Black Wing, Toronto ON M5G 1X8; fax 416 813-7369; [email protected]

Evidence-Based SurgeryChirurgie factuelle

The efficacy and risks of using povidone-iodine irrigation to prevent surgical siteinfection: an evidence-based review

Josie Chundamala, MA; James G. Wright, MD, MPH

Department of Surgery, The Hospital for Sick Children, Toronto, Ont.

2007 Canadian Medical Association Can J Surg, Vol. 50, No. 6, December 2007 473

Introduction: Surgical site infection is a serious complication of surgery. This evidence-based reviewsought to determine the efficacy and risks of using povidone-iodine irrigation to prevent surgical site in-fection. Methods:We searched MEDLINE and EMBASE for randomized controlled trials (RCTs) orcomparative studies only (level of evidence IIII). Results: Of the 15 included studies, all of which were

level I or level II evidence (11 RCTs and 4 prospective comparative studies), 10 found povidone-iodineirrigation to be significantly more effective at preventing surgical site infection than the comparison in-terventions of saline, water or no irrigation. No significant risks were associated with the use of povi-done-iodine irrigation other than increased postoperative serum iodine. Conclusion: Povidone-iodineirrigation is a simple and inexpensive solution with the potential to prevent surgical site infection.

Objectif : Linfection du site de lintervention constitue une complication srieuse de la chirurgie.Cette critique factuelle voulait dterminer lefficacit et les risques de lutilisation de lirrigation par so-lution de povidone-iode pour prvenir linfection du site opratoire. Mthodes : Nous avons effectudans MEDLINE et EMBASE une recherche portant uniquement sur des tudes contrles randomises(ECR) ou des tudes comparatives (niveaux de preuve IIII). Rsultats : Des 15 tudes incluses, quiprsentaient toutes un niveau de preuve I ou II (11 ECR et 4 tudes comparatives prospectives), 10ont rvl que lirrigation au moyen dune solution de povidone-iode avait t beaucoup plus efficacepour prvenir linfection du site dintervention que autres mesures compares (application de solutions

salines ou deau, ou labsence dirrigation). Aucun risque significatif na t associ lutilisation de lir-rigation la povidone-iode, sauf llvation de la concentration srique diode aprs lintervention.Conclusion : Lirrigation au moyen dune solution de povidone-iode est un moyen simple et peu co-teux de prvenir linfection du site dintervention.


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(19802006). The following searchstring was used in MEDLINE: (povi-done-iodine / or betadine.mp.) andirrigation / and surgical wound infec-tion/. In EMBASE, the followingsearch string was used: (povidoneiodine / or betadine.mp.) and (lavage/ or irrigation.mp.) and surgical in-fection/. The search was limited tohuman beings and to articles pub-lished in English. The results fromboth searches were exported to End-Note (The Thompson Corp., Philadel-phia, Pa.) where duplicate results wereremoved. Articles mentioned in the ref-erence lists of these results were alsoretrieved.

To be eligible, studies had to befocused on the efficacy or risks, orboth, of povidone-iodine irrigationto prevent surgical site infection; tohave a sample size greater than 1;and to be either a randomized con-trolled trial (RCT) or a comparativestudy. Studies were excluded if theydealt with the treatment of surgicalsite infection instead of its preventionor if they used povidone-iodine topi-cally rather than as an irrigation solu-

tion to prevent surgical site infection.Studies were also excluded if they fo-cused on eye, oral, breast or gyneco-logical surgery. The 15 studies thatmet all the inclusion criteria could bedivided into 4 surgical areas: general,cardiovascular, orthopedic and uro-logic. These 15 studies in 4 surgicaldisciplines formed the basis of ourreview.

We extracted the following in-formation from the studies: author,

year, country, study design, patientage, surgical procedure, samplesize, concentration and amount ofpovidone-iodine, comparison inter-vention used, outcome and risks.When provided by the studies, thefollowing information was also ex-tracted: antibiotics used in additionto povidone-iodine irrigation, defi-nition of wound infection and bac-terial contamination of patients(clean, dirty, etc.).

We also classified the studies ac-cording to the levels of evidence

described by Wright and colleagues,6

who categorize therapeutic studiesfrom level I (stronger evidence) tolevel V (weaker evidence) on the ba-sis of study design. In our review,only level IIII evidence was consid-ered. Level I evidence derives fromhigh-quality RCTs and systematicreviews of level I studies with consis-tent results. Level II evidence com-prises RCTs of lesser quality (i.e.,those with no blinding or improperrandomization), prospective compar-ative studies, systematic reviews oflevel II studies or level I studies withinconsistent results. Level III evi-dence encompasses casecontrolstudies, retrospective comparativestudies and systematic reviews oflevel III studies.6

Findings

The 15 included studies are summa-rized in Table 1. The years of publi-cation ranged from 1977 to 2006.Two examined the efficacy ofpovidone-iodine irrigation to preventsurgical site infection in multiple

types of surgery, whereas 8 focusedon general, 2 on cardiovascular, 2on orthopedic and 1 on urologicsurgery. Of the 15 studies, 11 wereRCTs, 3 of which were single-blind(none were double-blind); 4 wereprospective comparative studies.Three of the 15 studies were consid-ered level I evidence, 12 level II evi-dence and none level III evidence.

Efficacy of povidone-iodine

irrigation in surgery in general

As noted, 2 studies investigated theuse of povidone-iodine irrigation inmultiple types of surgery. Sindelarand Mason3,4 conducted an RCT atthe University of Maryland Hospitalwhere patients ranged in age from 9to 80 years and had surgery that in-cluded general (abdominal and gas-trointestinal) and urologic (geni-tourinary) procedures. Of the 500

patients enrolled, 242 were ran-domly allocated to 10% povidone-

iodine (1% available iodine) irriga-tion of the subcutaneous tissue for60 seconds at operation, and 258were randomly allocated to anequivalent amount of saline irriga-tion. Patients were classified as clean,potentially contaminated, contami-nated or dirty. Patients in the latter3 groups received combined clin-damycin and gentamicin as antibi-otics preoperatively to 48 hourspostoperatively. When possible renalimpairment or allergy was present,doxycycline was used instead. Infec-tion was defined as pus from the in-cision site within 12 weeks aftersurgery along with bacteria recov-ered from a wound culture. Theinfection rate was 2.9% in the treat-ment group and 15.1% in the con-trol group (p < 0.001). The treat-ment group did not experience anyinterference with wound healing oradverse reactions.

In a prospective comparativestudy, Singh and colleagues7 exam-ined 90 patients undergoing clean-contaminated operations who weredivided into 3 equal groups. Group A

patients received irrigation of the op-erative wound with 5% povidone-iodine. Group B patients receivedirrigation with 5% povidone-iodineand 5 mg/mL of metronidazole.Group C patients received irrigationwith sterile normal saline. The infec-tion rate was 30% in Group C and10% in Group A and Group B (p=0.056). No antibiotics were used inthis study. Participants age and ad-verse effects were not identified.

Efficacy of povidone-iodine

irrigation in general surgery

Of the 8 studies related to generalsurgery, 1 was a prospective com-parative study and 7 were RCTs. Inthe prospective comparative study,Barr8 examined patients undergoinggastrointestinal surgery, 35 of whomreceived 2-minute lavage with Beta-dine solution (age range 892 yr)

and 60 of whom did not (age notprovided). Patients were classified as

Chundamala and Wright

474 J can chir, Vol. 50, No 6, dcembre 2007


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Povidone-iodine irrigation to prevent surgical site infection

Can J Surg, Vol. 50, No. 6, December 2007 475

Table1

Summaryoffindingsforpovidone-iodineirrigationtopreventsurgicalsitein

fection

Population

Study

Year

Country

Level

Studydesign

Age,yr

Surgicalprocedure

PA

Definitionofinfection

Intervention

Comp

arison

Out-

come

(+/)*

Surgeryingeneral

Sindelarand

Mason

3,4

1977;

1979

United

States

II

RCT

980

Includedgeneraland

urologicprocedures

(n=500)

Y

Pusfromincisionsite

within12wk

after

surgeryalongwith

bacteriarec

overed

fromwound

culture

10%povidone-

iodine

irrigation

(n=242)

Salineirriga

tion

(n=258)

+

5%povidone-iodine

irrigation+

5mg/mL

ofmetronidazole

(n=30)

Singhetal7

1988

India

II

Prospective

comparativestudy

NA

Variouscleanor

contaminated

operations

(n=90)

N

NA

5%povidone-

iodineirrigation

(n=30)

Sterilenorm

alsaline

irrigation(n=30)

Generalsurgery

Barr

8

1978

United

States

II

Prospective

comparativestudy

NA

Gastrointestinal

N

NA

Betadinelavage

(n=35)

Nolavage

(n=60)

+

Sindelarand

Mason

9

1979

United

States

II

RCT

Laparotomy

(n=168)

Y

Abscessform

ation

1%povidone-

iodineirrigation

Salineirriga

tion

+

1%povidone-

iodineirrigation

(n=154)

Noirrigatio

n

(n=142)

deJong

etal10

1982

The

Netherlands

II

RCT

5

Intra-abdominalor

inguinalhernia

operations

N

Dischargefrom

woundwithin4wk

aftersurgery

ora

positivecultureoffluid

fromwound

10%povidone-

iodineirrigation

(n=149)

Noirrigatio

n

(n=137)

Sterilewater

irrigation(n=31)

Tigheetal11

1982

Ireland

II

RCT

3.574

Appendectomy

(n=131)

Y

Presenceof

puswith

orwithoutprobing

1%Betadine

irrigation(n=49)

Noirrigatio

n(n=51)

Rogersetal121983

United

States

II

RCT

Mean60.2

Generalsurgery

(n=187)

Y

Pusfromwoundwithin

1moofsurgery

10%povidone-

iodine(1%avail-

ableiodine)

irrigation(n=86)

Normalsaline

irrigation

(n=101)

Johnson

etal13

1985

United

Kingdom

II

RCT

Intervention

group:mean68.3

(range4886)

Comparison

group:mean67.2

(range5280)

Abdominoperineal

excisionoftherectum

forcarcinomaor

proctectomyfor

carcinoma(n=56)

N

Purulentwou

nd

dischargeorwound

dischargewith

bacteriacultured

1%povidone-

iodineirrigation

(n=28)

Sterilenorm

alsaline

irrigation

(n=28)

+

Contin

uedonnextpage


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Chundamala and Wright

476 J can chir, Vol. 50, No 6, dcembre 2007

Table1continued

Popu

lation

Study

Year

Country

Level

Studydesign

Age,yr

Surgicalprocedure

PA

Definitionofinfection

Intervention

Comp

arison

Out-

come

(+/)*

Parkeretal14

1985

United

Kingdom

II

RCT

Intervention

group:mean69

Comparison

group:mean68

M

ajorresectionfor

largebowel

c

arcinoma

(

n=45)

Y

Pusdischargingfrom

wound

10%aqueous

povidone-iodine

irrigation(n=22)

Waterirriga

tion

(n=23)

+

Sindelar

etal15

1985

United

States

II

RCT

Intervention

group:mean51.5

(range1975)

Comparison

group:mean51.7

(range2069)

Overall:mean

51.4

(range1975)i

ntra-abdominal

(

n=75)

Y

NA

1%povidone-

iodine(0.1

%

availableiodine)

irrigation(n=37)

Salineirriga

tion

(n=38)

+

Cardiovascularsurgery

Angelini

etal16

1990

United

Kingdom

II

Prospective

comparativestudy

Intervention

group:mean61

Comparison

group:mean58

E

arlyrepeat

s

ternotomyfor

p

ostoperative

h

emorrhage(n=43)

Y

Presenceofpurulent

dischargealongwith

apositivecu

lturefor

bacteria

Aqueous

povidone-iodine

irrigation(n=22)

Noirrigatio

n

(n=21)

+

Koetal17

1992

United

States

I

Single-blindRCT

NA

C

ardiopulmon-ary

b

ypasssurgerywith

s

ternotomyincision

(

n=1980)

Y

Unusualpain

,fever,

tenderness,induration,

drainageorerythema

Povidone-iodine

(0.5

%inNaCl)

irrigation

(n=990)

Saline(0.9%

inNaCl)

irrigation(n

=990)

Orthopedicsurgery

Chengetal18

2005

Taiwan

I

Single-blindRCT

intervention

group:mean64

Comparison

group:mean61

S

pinalsurgery

(

n=414)

Y

Unusualpain

,fever,

tenderness,induration,

drainageorerythema

0.3

5%povidone-

iodineirrigation

(n=208)

Normalsaline

irrigation

(n=206)

+

Changetal192006

Taiwan

I

Single-blindRCT

Intervention

group:mean67.1

(range2082)

Comparison

groupmean65.4

(range2289)

P

rimaryinstrumental

lumbosacral

p

osterolateralfusion

d

uetodegenerative

s

pinaldisorderwith

s

egmentalinstability

(

n=244)

Y

NA

0.3

5%povidone-

iodineirrigation

(n=120)

Normalsaline

irrigation

(n=124)

+

Urologicsurgery

Richter

etal20

1991

Israel

II

Prospective

comparativestudy

mean64(range

5590)

O

penprostatectomy

(

n=156)

Y

Redness,swe

lling,pus

withapositiv

eculture

NA

Noirrigatio

n

(n=76)

+

PA=prophylacticantibiotics;Y=yes;N=no;RCT=randomizedcontrolledtrial;NA=notavailable;N

aCl=sodiumchloride;

*+=interventionwassignificantlymoreeffectiveth

ancomparison;=interventionwasnotsignifican

tlymoreeffectivethancomparison.


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clean-contaminated or contami-nated. In the group that receivedBetadine lavage, 2 of 35 (5.7%) de-veloped wound infection; in thegroup that did not receive Betadinelavage, 23 of 60 (38.3%) developedwound infection (p < 0.001). Nosignificant changes in triiodothyro-nine (T3) or thyroxine (T4) levels,which were assessed in 12 patientsin the Betadine lavage group, wereobserved. In addition, no deleteri-ous effects to the wounds occurredfrom Betadine lavage, and woundshealed without evidence of indura-tion or inflammation except wheninfection occurred. The use of an-tibiotics was not mentioned in thisstudy.

Sindelar and Mason9 carried outan RCT of 168 patients undergoinglaparotomy at the University ofMaryland Hospital. The age of pa-tients was not identified. Patientswere classified as contaminated ordirty. All the patients received com-bined clindamycin and gentamicin asantibiotics preoperatively to 48 hourspostoperatively. When possible renal

impairment or allergy was present,doxycycline was used instead. Thetreatment group (n= 80) received ir-rigation of the peritoneal cavity for60 seconds before closure of the ab-domen with 1 L of 1% povidone-iodine (1:9 dilution of stock povi-done-iodine aqueous solution withsaline solution giving 0.1% availableiodine in diluted form). The controlgroup (n= 88) received irrigation for60 seconds with saline. Infection was

defined as abscess formation. In thetreatment group, 1 of 80 patients(1.3%) developed an abscess, whereasin the control group 9 of 88 patients(10.2%) developed an abscess (p

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