6.6Antiseptic skin preparation

Bibliographic detailsStudy type and evidence levelPatient characteristicsIntervention and comparisonsOutcome measures, follow-up and effect sizeComments
Alexander 1985

Definitive Study 96

Location of study: Cincinnati, USA
RCT

EL = 1+
Total of 480 patients undergoing elective surgery.
234 clean surgery
246 non clean surgery

Inclusion criteria: ability to apply incise drape and informed consent

Exclusion criteria: allergy to iodine, dirty wounds and areas difficult to drape (perineal, genitalia, feet, upper extremities, head and neck)

Baseline comparability: sex, surgical service, attending surgeon, resident, type of operation, wound classification,
prophylactic antibiotics, hair removal, antibiotic irrigation and suction catheters.
Interventions:

Gp 1) One minute scrub 70% alcohol and polyester antimicrobial drape (n = 147)

Gp 2) One minute scrub 2% Iodine in 90% alcohol and polyester antimicrobial drape (n = 164)

Gp 3) 10 minute scrub Povidone-iodine (Betadine) soap, 2 applications of povidone iodine (Betadine) paint and cloth drape (n = 169)

NB Group 3 excluded from this review as concurrent change of antiseptic and drape
Outcomes

Infection Defn – Discharge of pus, with or without positive culture, assessed at 30 days postoperatively.

Clean surgery:
Gp 1) 1/76 Gp 2) 1/81 Gp 3) 1/77
All three infections were ‘superficial’

Clean-contaminated surgery:
Gp 1) 2/60 Gp 2) 3/72 Gp 3) 2/83

Contaminated surgery:
Gp 1) 0/11 Gp 2) 1/11 Gp 3) 0/9

Total:
Gp 1) 3/147 Gp 2) 5/164 Gp 3) 3/169

Study duration: 1983 – 1984

No funding information available

Applicable to UK
Alexander 1985

Preliminary Study 296

Location of study: Cincinnati, USA
RCT

EL = 1+
Total of 115 patients

Inclusion: ability to apply incise drape and informed consent

Exclusion: allergy to iodine, dirty wounds and areas difficult to drape (perineal, genitalia, feet, upper extremities, head and neck)

Baseline comparability: not stated
Interventions:

Gp 1) 1 minute scrub with 70% alcohol + iodophor polyester incise drape. (n = 45)

Gp 2) 1 minute scrub with chlorhexidine in alcohol (Hibitane) + iodophor drape as above (n = 28)

Gp 3) 1 minute scrub with 2% iodine in 50% alcohol + iodophor drape as above (n = 17)

Gp 4) 1 minute scrub with 2% iodine in 70% alcohol + iodophor drape as above (n = 12)

Gp 5) 1 minute scrub with 2% iodine in 90% alcohol + iodophor drape as above (n = 13)
Outcomes:

Infection Defn – Discharge of pus, with or without positive culture, assessed at 30 days postoperatively.

Incidence of infection:
Location of study: Cincinnati, USA

Study duration: 1982 – 1983

No funding information available

Applicable to UK
Gp 12/45
Gp 21/28
Gp 30/17
Gp 40/12
Gp 51/13
Total4/115

Brown 1984102

Location of study: Indiana, USA
RCT

EL = 1+
Total of 737 patients

239 obstetric
273 gynaecologic
225 general surgery

Inclusion: private and clinical services patients undergoing laparotomy of all types, mastectomy and caesarean

Exclusion: did not meet surgical procedure category

Baseline comparability: age, diagnosis, type of procedure, presence of major risk factors
Interventions

Gp 1) (Experimental) 0.5% Chlorhexidine spray in 70% alcohol (n = 378)

Gp 2) (Standard Tx/Control) Scrub (6 minutes) with iodine soap (0.75% iodine) then aqueous povidone iodine paint (n = 359)
Outcomes:

Infection Defn -
Minor wound infection classified as superficial separation (less than 1 cm)

Major infection with separation of greater than one third of
incision site or evidence of purulent exudate or abscess

Minor infection:
Gp 1) 23/378 Gp 2) 29/359

Major infection
Gp 1) 11/378 Gp 2) 6/359
Study duration: Dec 1979 – Nov 1980

No funding information available

Applicable to UK
Ellenhorn 2005106

Location of study: California USA
RCT

EL = 1+
Total of 234 patients

Inclusion: 234 patients undergoing non-laparoscopic abdominal operations

Exclusion: active infection, neutropenia, allergy, anticipated insertion of prosthetic material

Baseline comparability: Age, obesity, diabetes, perioperative antibiotics, ASA score, procedures (clean, clean-contaminated)

Loss to follow-up: Not stated
Interventions

Gp 1) 5-minute scrub with povidone iodine soap, absorption with sterile towel, aqueous povidone iodine paint (n = 115)

Gp 2) povidone iodine paint only (n = 119)
Outcomes

Infection Defn – wound infection (erythema or purulence requiring intervention):

Gp 1) 12/115 (10%)

Gp 2) 12/119 (10%)
Study duration: not given

No funding information

Applicable to UK
Kalantar-Hormozi 2005101

Location of study: Tehran, Iran
Quasi RCT

EL = 1−
Total of 1810 ‘outpatient patients

Inclusion: candidates for elective outpatient surgery (excision of naevus, scar revision, Z-plasty, excision of benign cysts, skin tumours and dermabrasion)

Exclusion: immunosuppression states, incomplete follow up and antibiotic usage at time of surgery

Baseline comparability: Age and procedure similar, sex significantly different
Interventions

Gp 1) Shower with soap before surgery, saline irrigation of operative site, no pre- or postoperative antibiotics (n = 905)

Gp 2) Shower with soap before surgery, povidone iodine to scrub and paint operative site, no pre- or postoperative antibiotics (n = 905)
Outcomes

Infection defn – redness, swelling, discharge and wound dehiscence observed within one month

Gp 1 – 0/905

Gp 2 – 0/905

Study adequately powered.
Study duration: 1994–2002

No funding information

Applicable to UK
Kothuis 1981103
Location of study: Leyden, Netherlands
Quasi RCT

EL = 1−
Total of 220 patients

Inclusion: patients undergoing an elective laparotomy

Exclusion: not stated

Antibiotic prophylaxis given to colorectal and vascular surgery patients.

Baseline comparability: sex, age, diagnosis, procedure, clinical features
Interventions

Gp 1) skin disinfection with alcohol 70% and iodine tincture 2%, then application of iodine tincture to wound edges pre-suturing of skin.

Gp 2) skin disinfection with 10% povidone iodine solution and drying, then10% povidone iodine application to skin and subcutaneous wound edges pre-suturing of skin
Outcomes

Wound healing was classified as
  1. primary and
  2. complicated wound healing which included erythema oedema, haematoma,
seroma, or the formation of a wound abscess.
Observations made for at least 14 days postoperatively

Gp 1) 24/102
Gp 2) 23/118
Study duration: not given

No funding information

Applicable to UK
Roberts 1995

Location of study: New Jersey USA
RCT

EL = 1+
Total of 200 adult patients
All clean surgery

Inclusion: consecutive consenting Patients undergoing CABG

Exclusion: allergy to iodine

Baseline comparability: no difference for age, diabetes, vascular disease or postoperative variables, although sex of patients not stated
Interventions

Gp 1) Iodophor-in-alcohol, film forming, water insoluble antiseptic painted on chest and each leg and allowed to air dry for 2–3 minutes (n = 104)

Gp 2) Aqueous Iodophor scrub (5 to 10 minutes) and paint of chest and legs then blotted dry with sterile towel (control)(n = 96)

Iodophor impregnated incise drape on all chest wounds of both groups but not leg wounds.
Outcomes

CDC guidelines – wound appearance, drainage and cultured organisms.

Purulent material drained, not necessarily positive culture. Superficial infection being skin, subcutaneous tissue and muscle above fascial layer.
Deep infection being below fascial layer.
Observed 2 weeks postoperatively and telephoned at 30 days.

Gp 1) 10/104
Gp 2) 9/96
Study duration: 1 year

No funding information

Applicable to UK
Segal 2002105

Location of study: Houston USA
RCT

EL = 1+
Total of 209 adult patients All clean surgery

Inclusion: CABG, one or more high risk predictive factor

Exclusion: pre-existing infection, allergy to iodine, CPR in progress

Baseline comparability: age, type of surgery
Interventions

Gp 1) Povidone-iodine paint

Gp 2) Povidone-iodine five minute scrub then paint

Gp 3) One-step iodophor/alcohol water insoluble film

Gp 4) One-step iodophor/alcohol water insoluble film with iodine
impregnated incise drape
Outcomes

Infection defn – Drainage, redness, tenderness, or sternal instability observed over 6 wk period

Gp 1) 7/49
Gp 2) 7/45
Gp 3) 1/49
Gp 4) 3/48
Study duration: not given

No funding information

Applicable to UK

From: Evidence tables

Cover of Surgical Site Infection
Surgical Site Infection: Prevention and Treatment of Surgical Site Infection.
NICE Clinical Guidelines, No. 74.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2008 Oct.
Copyright © 2008, National Collaborating Centre for Women’s and Children’s Health.

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