Desinfectie huid en slijmvliezen Module 1.2 Evidence-tabellen

Wong, 2019

Type of study: Randomized control trial

Setting:

Pediatric clinic

Country:

Canada

Funding:

Funding was provided by a Dean’s award to Dr. Taddio and miscellaneous

funds by Dr. Taddio

Conflicts of interest:

None

Inclusion criteria: Healthy children aged 0-18 years eligible to receive between one and four vaccinations (intramuscular or subcutaneous) in accordance with the Ontario immunization schedule

Exclusion criteria:

- parent was not fluent in English, unavailable for follouw up 15 days post-vaccination, previously participated in the study, child have documented allergy to isopropyl alcohol, was taking antibiotics or had contraindication to vaccination

N total at baseline:

170 of 386 eligible participants were recruited. In total, 279 vaccinations were administered

Intervention: 85 patients. 119 vaccinations administered intramuscularly and 23 subcutaneously

Control: 85 patients. 118 vaccinations administered intramuscularly and 19 subcutaneously.

Age ± SD:

I: 5.6 years ±5.1

C: 5.9 ± 5.6

Sex:

Intervention: 53% male

Control: 60% male

Skin preparation with a 70% isopropyl alcohol swab at the pre-defined injection site(s) for 30 seconds followed by at least 30 seconds drying time prior to vaccine injection

Skin preparation with a 70% isopropyl alcohol swab adjacent to the pre-defined injection site(s) for 30 seconds followed by at least 30 seconds drying time prior to vaccine injection

Length of follow-up:

Until 14-day post-vaccination

Loss-to-follow-up:

Intervention:

Day 5: 0% (0/85)

Day 14: 16.5%. From 14 patients the diary data were missed

Reasons: diary data did not return from parents

Control:

Day 5: 2.4%. From 2 out of 85 patient data from telephone survey were missed

Day 14: 18.8%. From 16 out of 85 patients the diary data were missed

Reasons: not described

Incomplete outcome data:

7 participants (unknown from which group) were invited for a consultation on Day 5, from which only 1 participant returned.

Cellulitis or Infectious abscess:

Intervention: 0% (0/71)

Control: 0% (0/67)

Not applicable

Khawaja, 2013

Type of study: Quasi experimental

Setting:

Different clinics of a hospital

Country:

Saudi-Arabia

Funding:

Swab culture test were free of cost given by administration of King Khalid University

Hospital, Riyadh

Conflicts of interest:

None

Inclusion criteria:

Patients from different clinics of the hospital eligible for intramuscular, subcutaneous, or intradermal (tuberculosis screening) to administer different drugs and vaccines.

Exclusion criteria:

Patients with skin disease, co-morbidity (e.g., immunosuppressed or heart valve disease), and eligible for injection with antimicrobial drug

N total at baseline:

407 patients

Age (range) and sex

Intramuscular

Intervention: 24.5 years (1 month-58 years).

Male:Female =

1:1.1

Control: 26 years (1

month-66 years). Male:Female =

1:1.2

Subcutaneous

Intervention: 23 years (5 months-32 years).

Male:Female =

1:0.96

Control: 19 years (6mon-32 years)

Male:Female =

1:1.1

Intradermal

Intervention: 19 years (1week-44 years).

Male:Female =

1:1.2

Control: 23 years (1 week – 36 years).

Male:Female =

1:1.13

Skin preparation with 70% isopropyl alcohol swab for 30 seconds followed by 30 seconds drying time prior to intramuscular, subcutaneous, or intradermal injection.

No skin preparation prior to intramuscular, subcutaneous, or intradermal injection

Length of follow-up:

Patients with erythema, pain, swelling, fever, and abscess formation on day 2 or 3 post-injection were followed up over a period of three weeks on weekly basis (direct or telephonic consultation) by a family physician blind to swab status to assess infection signs or symptoms.

Loss-to-follow-up:

Intervention:

26.7% (59/221)

Reasons: unknown

Control:

20.4% (38/186)

Reasons: unknown

Cellulitis, abscess formation, signs of systematic infection:

Intervention group: 0% (0/162)

Control group: 0% (0/148)

Not applicable

Koivisto, 1978

Type of study:

Cross-over

Setting:

Department of internal medicine of University School of Medicine

Country:

USA

Funding:

First author received grants form Finnish Ministry of Education and National Institutes of Health

Conflicts of interest:

Co-author is investigator of the American Diabetes Association

Inclusion criteria:

Insulin-dependent diabetic adult patients

Exclusion criteria:

Not reported

N total at baseline:

13 patients receiving daily a single, two or three doses of insulin

Age:

Range: 20-54 years

Sex:

Male: 46,1%

Skin preparation with 70% isopropyl alcohol swab for 5 seconds and no skin preparation prior to insulin injection on thigh, arm, or abdomen by all participants in alternate weeks.

Drying time alcohol swab not reported

No skin preparation and skin preparation with 70% isopropyl alcohol swab for 5 seconds prior to insulin injection on thigh, arm, or abdomen by all participants in alternate weeks.

Drying time alcohol swab not reported

Length of follow-up:

3 - 5 month

Loss-to-follow-up:

None

Signs of local or systematic infection:

0%, 0 of the thirteen patients with more than 1700 injections without skin preparation

Not applicable

Martinez, 2017

Type of study:

Randomized controlled trial

Setting and country:

Emergency room (ER), internal medicine ward (IMW), or intensive care units (ICU) from 2 teaching hospitals in Mexico

Funding:

Not reported

Conflicts of interest:

None

Inclusion criteria:

Patients ≥ 16 years with suspected bloodstream infection

Exclusion criteria:

Not reported

N total at baseline:

1,102 sets of blood culture

Number of patients not reported

Important prognostic factors²:

N of blood cultures sets per department:

- Emergency department: 348

- Medicine ward: 588

- Intensive care unit: 166

Initial skin antisepsis with isopropyl alcohol (IPA) with repeated back-and-forth strokes for 30 sec, drying time for 30 sec, followed by second skin antisepsis with 70% isopropyl alcohol swab (IPA)

Initial antisepsis with isopropyl alcohol (IPA) with repeated back-and-forth strokes for 30 sec, drying time for 30 s, followed by second skin antisepsis with 2% chlorhexidine gluconate in 70% isopropyl alcohol applicator (CHG)

Length of follow-up:

Not applicable

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

- overall: 1.0%

- IPA+70% IPA: 0.9% (5/563); per unit: ER 0.5% (1/197), IMW 1.3% (4/293), ICU 0% (0/73)

- IPA+CHG: 1.9% (10/539); per unit: ER 1.9% (3/151), IMW 2.4% (7/295), ICU 0% (0/93)

Story-Roller, 2016

Type of study:

Randomized crossover trial

Setting and country:

Eight nursing units at a hospital in the USA

Funding:

None

Conflicts of interest:

None

Inclusion criteria:

Patients with suspected bloodstream infection

Exclusion criteria:

Blood culture samples taken from a patient using a skin antiseptic not assigned to a particular nursing unit.

N total at baseline:

6,095 sets of blood cultures

Number of patients not reported

Important prognostic factors²:

bone marrow transplant unit, medical oncology unit, medical oncology unit, surgical oncology unit, surgical inpatient unit, medical inpatient unit, medical intensive care unit, and respiratory care unit

isopropyl alcohol (IPA) pad for 30 sec followed by

2% iodine tincture solution (IT; 2% iodine, sodium iodide, 47% ethyl alcohol, CareFusion) drying time for 30 s

isopropyl alcohol (IPA) pad for 30 sec followed by 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG; ChloraPrep 1-step applicator).

Length of follow-up:

3-month block during a 1-year period. No wash-out period.

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

- overall: 3.9%

- IPA+IT: 3.9% (123/3130)

- IPA+CHG: 3.9% (115/2965)

Mean blood contaminated rates units: four oncology units: 2.3%; another four units: 5.3%

Washer, 2013

Type of study:

Group-randomized crossover trial

Setting and country:

Three medical-surgical wards at a hospital in the USA

Funding:

Blue Cross Blue Shield of Michigan Foundation

Conflicts of interest:

None

Inclusion criteria:

Adult patients for whom clinicians had ordered blood cultures

Exclusion criteria:

Patients admitted to intensive care units

N total at baseline:

12,904 sets of blood cultures from 3,879 patients

Important prognostic factors²:

Age: Mean 56.8 years ± 17.9

Race:

- Caucasian: 77.1%

- African American: 13.4%

- Another/unknown: 9.6%

Comparison of three skin antiseptic agents with a difference in method:

- Method regarding 10% povidone iodine aqueous solution (PI) packaged in a 0.67 mL Sepp applicator and iodine tincture (IT; 2% iodine and 2% sodium iodide diluted in 50% ethanol):

(1) initial skin antisepsis scrubbing with an alcohol prep pad (AP).

(2) both agents were applied in concentric circles away from the venepuncture site, covering an area 4-5 cm in diameter. PI was dried for 60 sec and IT for 30 s

- Method regarding 2% chlorhexidine gluconate/70% isopropyl alcohol (CHG) packaged in a 1.5-ml Frepp applicator: no initial skin antisepsis with an alcohol prep pad, CHG was directly applied in a back-and-forth motion over the venepuncture site, covering an 4-5 cm in diameter, then dried for 30 s

Comparison of three skin antiseptic agents with a difference in method:

- Method regarding 10% povidone iodine aqueous solution (PI) packaged in a 0.67 mL Sepp applicator and iodine tincture (IT; 2% iodine and 2% sodium iodide diluted in 50% ethanol):

(1) initial skin antisepsis scrubbing with an alcohol prep pad (AP).

(2) both agents were applied in concentric circles away from the venepuncture site, covering an area 4-5 cm in diameter. PI was dried for 60 sec and IT for 30 s

- Method regarding 2% chlorhexidine gluconate/70% isopropyl alcohol (CHG) packaged in a 1.5-ml Frepp applicator: no initial skin antisepsis with an alcohol prep pad, CHG was directly applied in a back-and-forth motion over the venepuncture site, covering an 4-5 cm in diameter, then dried for 30 s

Length of follow-up:

5-month block, 1-month wash-out period before the next skin antiseptic agent was applied, during a 17-month period

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

- overall: 0.76% (95%CI: 0.62-0.92)

- AP+PI: 0.58% (95%CI: 0.38-0.86)

- AP+IT: 0.76% (95%CI: 0.52-1.07)

- CHG: 0.93% (95%CI: 0.67-1.27)

Order effect: p=0.44

Carryover effects: p=0.40

25 blood cultures from 16 patients were obtained with alcohol skin antisepsis only due to iodine allergy, none of them were contaminated

Suwanpimolkul, 2008

Type of study:

Randomized controlled trail

Setting and country:

Twelve medical wards (MWs), two intensive care units (ICUs), and one emergency room (ER)at a teaching hospital in Thailand

Funding:

Not reported

Conflicts of interest:

None

Inclusion criteria:

Patients ≥ 16 years with signs or symptoms of bacteremia

Exclusion criteria:

Patients with current skin infection or dermatitis at the venepuncture site

N total at baseline:

2146 blood culture samples from 1073 patients

Important prognostic factors²:

Sex: 47% M/ 53% F

Units:

• Wards and ICUs: 65.4% blood culture samples
• Emergency room: 34.6% blood culture samples

2% chlorhexidine gluconate in 70% alcohol (CHG) applying twice

10% aqueous povidone-iodine (PI) applying twice

Length of follow-up:

2-month

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

- overall: 5.03%; MWs and ICUs 3.3%, ER

- CHG (2x): 3.2%; MWs and ICUs 2.6% (18/695), ER 4.3% (16/373)

- PI (2x): 6.9%; MWs and ICUs 3.9% (28/709), ER 12.5% (46/369)

OR 0.45 (,95%CI:0.30-0.68, p<0.001)

Calfee, 2002

Type of study:

Randomized crossover trail

Setting and country:

Emergency department and all inpatient care units at a hospital in the USA

Funding:

Financial support provided by Becton Dickinson

Conflicts of interest:

Not reported

Inclusion criteria:

Patients in emergency department and admitted to all inpatient care units

Exclusion criteria:

Patient admitted to neonatal intensive care unit. 114 blood culture samples for which no companion culture for comparison

N total at baseline:

12,806 blood cultures

Number of patients not reported

Important prognostic factors²:

Group 1: emergency department; group 2: medical and oncology wards, medical intensive care unit; group 3: cardiac , pediatric wards, obstetrics-gynaecology wards, and cardiac and pediatric intensive care units; group 4: surgical wards and intensive care units

Four skin antiseptic agents:

- 3 swabsticks soaked in 10% povidone-iodine (PI)

- 3 swabsticks soaked 70% isopropyl alcohol (IPA)

- 3 swabsticks soaked iodine tincture (IT; 2% iodine and 2% potassium iodide in 47% ethyl alcohol iodine tincture)

- 3 swabsticks soaked povidone-iodine in 70% ethyl alcohol (Persist)

The venepuncture site was disinfected by using the three swabsticks of one agent one after ananother, beginning in the center and continuing in an outward direction using circular strokes for an area 5 – 7 cm in diameter successively and allowed to dry for at least one min.

Four skin antiseptic agents:

- 3 swabsticks soaked in 10% povidone-iodine (PI)

- 3 swabsticks soaked 70% isopropyl alcohol (IPA)

- 3 swabsticks soaked iodine tincture (IT; 2% iodine and 2% potassium iodide in 47% ethyl alcohol iodine tincture)

- 3 swabsticks soaked povidone-iodine in 70% ethyl alcohol (Persist)

The venepuncture site was disinfected by using the three swabsticks of one agent one after ananother, beginning in the center and continuing in an outward direction using circular strokes for an area 5 – 7 cm in diameter successively and allowed to dry for at least one min.

Length of follow-up:

3-month block, 2-weeks wash-out period until study groups have used all four antiseptic agents during a 13.5-month period

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

-overall: 2.62% (333/12,692)

- PI (3x): 2.93% (99/3,378)

- IPA (3x): 2.50% (78/3,125)

- IT (3x): 2.58% (81/3,138)

- Persist (3x): 2.46% (75/3,051)

Intragroup differences among contamination rates between any of the four antiseptic agents: p≥0.1

Mimoz, 1999

Type of study:

Randomized controlled trial

Setting and country:

Three adult intensive care units at a French hospital

Funding:

Zeneca Pharma and Université Paris XI

Conflicts of interest:

Not reported. Funding agencies were not involved in designing, conducting, reporting, or submitting manuscript

Inclusion criteria: Adult patients who had at least one blood culture drawn through a peripheral vein

Exclusion criteria:

Adult patient with apparent skin infection

N total at baseline:

2041 blood culture samples from 403 patients

Important prognostic factors²:

Medical, surgical, and neurosurgical intensive care unit

10% aqueous solution of povidone-iodine (PI; Betadine), applied vigorously and allowed to dry for 15–30 s after application.

alcoholic solution of 0.5% chlorhexidine (CHG; Hibitane Champ), applied vigorously and allowed to dry for 15–30 s after application.

Length of follow-up:

21-weeks

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate:

- overall: 2.4% (48/2041)

- PI: 3.3% (34/1022)

- CHG: 1.4% (14/1019)

OR: 0.40 (95% CI: 0.21-0.75; p=0.004)

Little, 1999

Type of study:

Randomized controlled trial

Setting and country:

Adult inpatient units at an American tertiary care teaching hospital

Funding:

Innovations in Healthcare Program of BJC Health System, St. Louis, Missouri. Kits containing 2% iodine tincture and alcohol scrub device were supplied by Medi-Flex Hospital Products, Inc, Overland Park, Kansas

Conflicts of interest:

Not reported

Inclusion criteria:

Adult patients

Exclusion criteria:

Patients admitted to the emergency department or intensive care units

N total at baseline:

3,851 blood culture samples from 1,503 patients

Important prognostic factors²:

Initial skin antisepsis with isopropyl alcohol (IPA) gauze pad for 1-min followed by second skin antisepsis with

10% povidone-iodine (PI) gauze pads, and allowed to dry for 2-mins

Initial skin antisepsis with 70% isopropyl alcohol (IPA) applicator for 1-min followed by second skin antisepsis with 2% iodine tincture in 47% alcohol, (IT) and allowed to dry for 2-mins

Length of follow-up:

8-month

Loss-to-follow-up:

Not reported

Incomplete outcome data:

Not reported

Outcome measures and effect size (include 95%CI and p-value if available):

Blood culture contamination rate

- Overall: 3.1% (120/3851)

- IPA+PI:

3.8% (74/1947)

- IPA+IT: 2.4% (46/1904)

OR 1.6 (95%CI: 1.1-2.4; p=0.01)