CC BY-NC-ND 4.0 · Rev Bras Ortop (Sao Paulo) 2020; 55(02): 156-162
DOI: 10.1055/s-0039-3400520
Artigo Original
Básica
Sociedade Brasileira de Ortopedia e Traumatologia. Published by Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil

Antisepsis Techniques in Orthopedic Surgical Procedures: A Comparative Study[*]

Article in several languages: português | English
1   Universidade do Vale do Sapucaí, Pouso Alegre, Minas Gerais, MG, Brasil
2   Departamento de Ortopedia e Traumatologia, Hospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, MG, Brasil
,
Mauro de Castro Carvalho
2   Departamento de Ortopedia e Traumatologia, Hospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, MG, Brasil
,
Rafael Baroni Carvalho
2   Departamento de Ortopedia e Traumatologia, Hospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, MG, Brasil
,
Célio Alves Ferraz
2   Departamento de Ortopedia e Traumatologia, Hospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, MG, Brasil
,
Diba Maria S.T. Souza
1   Universidade do Vale do Sapucaí, Pouso Alegre, Minas Gerais, MG, Brasil
,
Taylor B. Schnaider
1   Universidade do Vale do Sapucaí, Pouso Alegre, Minas Gerais, MG, Brasil
2   Departamento de Ortopedia e Traumatologia, Hospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, MG, Brasil
› Author Affiliations
Further Information

Endereço para correspondência

Eugênio César Mendes, MD, MSc
Universidade do Vale do Sapucaí
Avenida Tuany Toledo 470, Pouso Alegre, Minas Gerais, MG, 37550-000
Brasil   

Publication History

16 August 2018

08 January 2019

Publication Date:
07 February 2020 (online)

 

Abstract

Objective To compare antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcohol-based chlorhexidine or chlorhexidine-based soap associated with alcohol-based chlorhexidine alone in surgical orthopedic procedures.

Methods This is a primary, randomized, analytical and single-center clinical trial consisting of 170 patients, who were divided into 2 groups. The combinations chlorhexidine-based soap + alcohol-based chlorhexidine (CSAC) and chlorhexidine-based soap + 70% ethyl alcohol + alcohol-based chlorhexidine (CSAAC) were tested in each group. The cultures were grown in mannitol and eosin methylene blue (EMB) after collection before skin preparation (time point 0), after skin preparation (time point 1) and at the end of the surgical procedure (time point 2).

Results There was no statistically significant difference regarding bacterial growth in mannitol and EMB between the groups at any time point. Moreover, there was no statistical difference between groups and time points regarding the type of bacterial growth in culture media.

Conclusion There was no difference between these antisepsis techniques for the prevention of surgical site infection in orthopedic procedures; in addition, a protocol containing measures to prevent infection in such procedures was developed.


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Introduction

Surgical site infection (SSI) is among the most researched subjects, and it is frequently associated with surgical complications, affecting up to one third of patients undergoing surgical procedures in low- and middle-income countries.

Data from the Centers for Disease Control and Prevention estimates that nearly 500 thousand SSIs occur each year, representing almost a quarter of nosocomial infections in the United States annually.[1]

In Brazil, although there are no systematic data, SSIs are ranked third among causes of infection, being found in approximately 14% to 16% of hospitalized patients. In addition to the physical, psychological and financial damages to patients, SSI can prolong the hospital stay by an average of seven to eleven days; moreover, it increases the chances of hospital readmission and additional surgeries, resulting in an exorbitant increase in care expenses, which may reach US$ 1.6 billion per year.[2] [3] Literature reviews provide historical data on antisepsis, from rudimentary procedures, which are evidently far from being safe and effective, to those known today.[4] In a systematic review, Lee et al[5] concluded that chlorhexidine-based compounds are more effective for surgical site antisepsis than iodine, leading to a significant cost reduction.

Mears et al,[6] Swenson et al,[7] Saltzman et al,[8] and Savage and Anderson[1] were able to prove the efficacy of chlorhexidine compared with iodine. Reichel et al[9] showed the effectiveness of alcohol + chlorhexidine in skin antisepsis.

It is agreed that the effectiveness of surgical preparation directly impacts the occurrence of SSIs, which depends on the antiseptic solution used and on the method of application. However, it is not clear which should be the antiseptic solution or association, the time for action, the application methodology, or the moment in which skin antisepsis should be performed. As such, the present study aims to compare the effectiveness of chlorhexidine-based soap + alcohol-based chlorhexidine (CSAC) and chlorhexidine-based soap + 70% ethyl alcohol + alcohol-based chlorhexidine (CSAAC) to evaluate the best way of skin preparation for orthopedic surgical procedures regarding bacterial growth and surgical time.


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Materials and Methods

The present is a primary, randomized, prospective, analytical, single-blinded and single-centered clinical study to compare antisepsis techniques using CSAC and CSAAC in orthopedic surgical procedures. The data were collected in the operating room and in a research laboratory from a high-complexity hospital from the Brazilian Unified Health System (Sistema Único de Saúde, SUS, in Portuguese). After approval by the Ethics in Research Committee on May 9, 2017 (under opinion number 2.054.709), the study was conducted from June to November 2017.

In total, 190 patients were selected according to the eligibility criteria, and the final sample was composed of 170 patients who would undergo orthopedic surgical procedures.

The inclusion criteria were: both male and female patients; those older than 18 years of age; patients submitted to all elective orthopedic surgical procedures; and those who signed the informed consent form (ICF). The exclusion criteria were: patients undergoing urgent/emergency surgery; patients with a known history of chlorhexidine allergy or who had any kind of skin or systemic reaction during its application; those with existing skin lesions; patients from the intensive care center; those with open fractures at the time of the initial care; and patients using external fixators for fracture stabilization. Cases of preoperative death and of loss of material were also excluded.

The patients who met the eligibility criteria were separated through a random number table generated by the website http://www.randomization.com (# 25432, May 8, 2017) into two groups: CSAC and CSAAC. The patients were properly prepared for the surgical procedure following the Health Care Infection Prevention Measures of the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA, in Portuguese),[3] including a full-body bath two hours prior to surgery with the use of 4% chlorhexidine in those undergoing major elective surgery or receiving orthopedic implants; the patients undergoing elective minor or medium-sized surgeries used only neutral soap in the full-body bath. Patients using plaster cast immobilizations were exempted from the full-body bath, since plaster removal would cause pain and discomfort, and it is associated with risks, including fracture-related skin perforation.

At the operating room, complying with the antibiotic prophylaxis protocol, the patients received intravenous (IV) cefazolin, 2 g diluted in 250 mL of saline solution, starting 30 minutes before the procedure; next, every 8 hours, 1 g of IV cephazolin was administered for 24 hours after surgery. The preoperative blood sugar level was measured 30 minutes before the procedure and immediately after surgery. Patients who had hair at incision sites underwent a hair clipping procedure using a 3M (Maplewood, MN, US) device; disposable blades were used for each patient, according to the previously mentioned Health Care Infection Prevention Measures.[3]

After anesthesia, sterile swabs were used to collect samples from the patient's skin microbiota at a previously selected location in the surgical site, in a 16-cm2 area determined by a previously cut paper field sterilized at the Sterilization Center. The samples were collected at the three time points.

All samples were placed in test tubes with 1 mL of buffered phosphate solution and sent to the research laboratory, where they were cultivated on plates with mannitol or eosin methylene blue (EMB) agar media.

All test tubes containing the collected swabs and culture plates were sequentially numbered according to each patient, from 1 to 170. The time points were identified as 0, 1 and 2. The number 0 corresponds to the materials collected before skin preparation; number 1 refers to materials collected after skin preparation with 4% chlorhexidine followed by excess removal with dry gauze or gauze soaked in 70% ethyl alcohol; and number 2 refers to the materials collected at the end of surgery ([Figure 1]).

Zoom Image
Fig. 1 Figures showing the time of sample collection. (A) Patient under anesthesia, with the surgical limb isolated with drapes; (B) sample collected before skin preparation; (C) skin preparation with chlorhexidine-based soap and excess removal; (D) sample collected after skin preparation; (E) sample collected at the end of the surgery, after surgical wound closure, with the patient still in the sterile environment.

In both groups, samples were collected from the surgical site before skin preparation (time point 0) with 4% chlorhexidine for 5 minutes. Any excess material was removed in a single, proximal to distal movement with a simple, sterile gauze soaked in 70% alcohol for the CSAAC group and a simple, sterile dry gauze for the CSAC group.

After skin preparation, sterile swabs were similarly used to collect samples in the previously studied area, followed by antisepsis with alcohol-based chlorhexidine and placement of surgical drapes (time point 1). At the end of the surgical procedure (after incision closure), while the patient was still at the sterile environment, a new sample was collected using the same technique at the same demarcated site (time point 2). The samples were placed separately in test tubes with 1 mL of buffered phosphate solution and sent to the laboratory for analysis.

After 48 hours of culture, the culture media were evaluated for organism growth. In case of growth, the number of colonies was counted, and Gram-positive (Staphylococcus aureus and non-aureus) and Gram-negative bacteria were identified. Samples from all time points, in both the mannitol and EMB media, were evaluated to verify if the number of colonies had decreased, increased or remained unaltered after skin preparation. In the case of growth in cultures from time point 2 (after incision closure), the plates were sealed with tape and sent to the Clinical Analysis Laboratory for sensitivity determination. Thus, all subjects were evaluated regarding the efficacy of the antisepsis, as well as the organisms growing at culture.

The data were tabulated in Microsoft Excel 2010 (Microsoft Corp., Redmond, WA, US) spreadsheets and submitted to statistical analysis. The Chi-squared test was performed using the Statistical Package for the Social Sciences (SPSS, IBM Corp. Armonk, NY, US), version 20.0.0, with the null hypothesis rejection level set at 5% (p ≤ 0.05). The numerical variables were analyzed using descriptive statistics, calculating mean and median values.


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Results

The present study compares the skin preparation performed at the Orthopedics and Traumatology Service using a chlorhexidine-based soap plus alcohol-based chlorhexidine and a chlorhexidine-based soap plus 70% ethyl alcohol and alcohol-based chlorhexidine. In total, 170 patients were eligible to participate in the study, and they were separated into 2 groups of 85 patients each. In the first group (CSAC), skin preparation was performed with chlorhexidine-based soap + alcohol-based chlorhexidine, whereas the skin preparation of the second group (CSAAC) was performed with chlorhexidine-based soap + 70% ethyl alcohol + alcohol-based chlorhexidine. During material collection, four sequential plates were contaminated; these plates were handled by the same resident, which justified the coincidence. Thus, these plates were eliminated, and the patients were excluded from the study. In total, 4 patients were excluded, curiously 2 from each group; as such, the final sample consisted of 166 patients divided into 2 groups of 83 patients each.

Regarding bacterial growth in the mannitol and EMB culture media, significant differences were found between the second and third time points (1 and 2) and time point 0 ([Table 1]); however, due to the lack of any intervention at this time point, this finding had no relevance for the present study. There were no statistically significant differences between other time points, indicating that there was no difference in the results of the two skin preparation methods ([Table 2]).

Table 1

Mannitol

Group

CSAAC

CSAC

Total

n

%

n

%

n

%

Time point 0–

before skin preparation

Negative growth

6

7.3

16

19.3

22

13.3

Positive growth

77

92.7

67

80.7

143

86.7

Total

83

100.0

83

100.0

166

100.0

Time point 1–

after skin preparation

Negative growth

52

62.7

43

51.8

94

57.0

Positive growth

31

37.3

40

48.2

71

43.0

Total

83

100.0

83

100.0

166

100.0

Time point 2–

after incision closure

Negative growth

52

62.7

51

61.4

103

62.0

Positive growth

31

37.3

32

38.6

63

38.0

Total

83

100.0

83

100.0

166

100.0

Table 2

EMB

Group

CSAAC

CSAC

Total

n

%

n

%

N

%

Time point 0–

before skin preparation

Negative growth

67

80.7

62

74.7

128

77.6

Positive growth

16

19.3

21

25.3

37

22.4

Total

83

100.0

83

100.0

165

100.0

Time point 1–

after skin preparation

Negative growth

77

92.7

73

88.0

149

90.3

Positive growth

6

7.3

10

12.0

16

9.7

Total

83

100.0

83

100.0

165

100.0

Time point 2–

after incision closure

Negative growth

75

90.4

74

89.2

149

89.8

Positive growth

8

9.6

9

10.8

17

10.2

Total

83

100.0

83

100.0

166

100.0

The type of bacterial growth in the mannitol and EMB culture media from samples collected after incision closure did not depend on the skin preparation method ([Tables 3] and [4]).

Table 3

Bacteria

Group

CSAAC

CSAC

Total

n

%

n

%

N

%

Negative growth

49

59.1

43

51.8

92

55.4

GPC

29

35.8

31

37.4

60

36.1

GNB

2

2.4

2

2.4

4

2.4

GPC and GNB

3

3.6

7

8.4

10

6.1

Total

83

100.0

83

100.0

166

100.0

Table 4

Bacteria

Group

CSAAC

CSAC

Total

n

%

n

%

N

%

Negative growth

51

61.4

52

62.6

103

62.0

GPC

26

31.3

27

32.6

53

31.9

GNB

0

.0

0

.0

0

.0

GPC and GNB

6

7.3

4

4.8

10

6.1

Total

83

100.0

83

100.0

166

100.0

Both methods of skin preparation resulted in similar bacterial colony-forming unit (CFU) values (expressed as n x10 UFC/mL) obtained in both culture media (EMB and mannitol) and at all time points (0, 1 and 2). The mean CFU values were 27.3213 × 10 CFU/mL and 27.5874 × 10 CFU/mL for the CSAC and CSAAC groups respectively ([Table 5]).

Table 5

Time point

Medium

Group

Mean value (x 10 CFU/mL)

Before skin preparation

EMB

CSAC

17.0843

CSAAC

12.1707

Total

14.6424

Mannitol

CSAC

116.7590

CSAAC

133.6951

Total

125.1758

Total

CSAC

66.9217

CSAAC

72.9329

Total

69.9091

After skin preparation

EMB

CSAC

4.9518

CSAAC

0.2317

Total

2.6061

Mannitol

CSAC

21.5542

CSAAC

4.1707

Total

12.9152

Total

CSAC

13.2530

CSAAC

2.2012

Total

7.7606

After incision closure

EMB

CSAC

0.3976

CSAAC

0.2439

Total

0.3212

Mannitol

CSAC

3.1807

CSAAC

15.0122

Total

9.0606

Total

CSAC

1.7892

CSAAC

7.6280

Total

4.6909

Total

EMB

CSAC

4.4779

CSAAC

4.2154

Total

5.8566

Mannitol

CSAC

47.1647

CSAAC

50.9593

Total

49.0505

Total

CSAC

27.3213

CSAAC

27.5874

Total

27.4353

Bacterial growth in the mannitol and EMB culture media from samples obtained at time point 2 (after incision closure) was observed in 39% of the cases. These samples were sent to the Clinical Analysis Laboratory of our institution, which identified the prevalence of Staphylococcus epidermidis (58.33%), followed by S. aureus (13.88%) ([Table 6]).

Table 6

Bacterium

Frequency (%)

Staphylococcus epidermidis

58.33

Staphylococcus aureus

13.88

Acinetobacter iwoffii

11.14

Staphylococcus saprophyticus

4.16

Staphylococcus warneri

4.16

Staphylococcus hominis

2.77

Staphylococcus auricularis

1.39

Staphylococcus capitis-capitis

1.39

Staphylococcus haemolyticus

1.39

Staphylococcus capitis-ureolyticus

1.39


#

Discussion

Widerström[10] evaluated the clinical importance of coagulase-negative staphylococci, particularly S. epidermidis, as a major cause of healthcare-associated infections. Its pathogenicity is favored by the natural niche in human skin, thus resulting in an opportune contamination point, which reinforces the importance of correct skin preparation.

The literature still debates the best association of antiseptic agents, as well as the method and time of application. Martínez et al[11] performed the first clinical trial to compare isopropyl alcohol and chlorhexidine in isopropyl alcohol for skin preparation to prevent blood culture contamination. These authors showed that blood contamination rates were not different when isopropyl alcohol and chlorhexidine were compared.[11]

A review of American English and French guidelines found that there is no consensus on how antiseptics should be applied. While the American and English guidelines are unclear about skin cleansing before antiseptic application (an approach that can improve the effectiveness of the antiseptic by reducing the cutaneous amounts of bacteria and protein material), the French guidelines recommend cleansing the skin with a detergent before disinfection.[12]

The results of the present study do not determine which is the best antiseptic association for orthopedic patients, but data from our hospital's Infection Control Center (ICC) ([Table 7]) obtained at the end of the study showed a reduction in ISS prevalence in such individuals, corroborating the principle that the development and adoption of a protocol ([Figure 2]) can significantly lower ISS rates.

Table 7

Month

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sept

Oct

Nov

Dec

Total

Number of surgeries

115

101

135

139

131

146

152

129

130

124

123

136

1,561

SSI

7

4

4

3

7

3

2

1

4

1

2

2

40

%

6.1

4.0

2.96

2.16

5.34

2.05

1.32

0.78

3.08

0.81

1.63

1.47

2.64

Zoom Image
Fig. 2 Pre- and perioperative measures for infection prevention in orthopedic surgeries.

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Conclusion

There was no statistical difference between skin preparation with chlorhexidine-based soap plus alcohol-based chlorhexidine or chlorhexidine-based soap plus 70% ethyl alcohol and alcohol-based chlorhexidine to prevent ISS in Orthopedics. However, the adoption of a pre-, peri- and postoperative protocol is effective in reducing SSI rates.

Further studies, with larger samples, may present more details regarding the best method for the application of antiseptics. Thus, the best agent and application method continue to be discussed.


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Conflito de Interesses

Os autores declaram não haver conflito de interesses.

* Study performed at Hospital das Clínicas Samuel Libânio, Pouso Alegre, MG, Brazil.



Endereço para correspondência

Eugênio César Mendes, MD, MSc
Universidade do Vale do Sapucaí
Avenida Tuany Toledo 470, Pouso Alegre, Minas Gerais, MG, 37550-000
Brasil   


Zoom Image
Fig. 1 Figuras ilustrando os tempos de coleta das amostras. (A) Paciente após ser anestesiado, com o membro a ser operado isolado com campos; (B) Coleta de amostra antes da degermação; (C) Realizada degermação com clorexidina degermante e retirado o excesso; (D) Coleta de amostra após a degermação; (E) Coleta de amostra ao final da cirurgia, após a sutura da ferida operatória, em ambiente ainda estéril.
Zoom Image
Fig. 1 Figures showing the time of sample collection. (A) Patient under anesthesia, with the surgical limb isolated with drapes; (B) sample collected before skin preparation; (C) skin preparation with chlorhexidine-based soap and excess removal; (D) sample collected after skin preparation; (E) sample collected at the end of the surgery, after surgical wound closure, with the patient still in the sterile environment.
Zoom Image
Fig. 2 Medidas pré- e peroperatórias de prevenção de infecção em cirurgias ortopédicas.
Zoom Image
Fig. 2 Pre- and perioperative measures for infection prevention in orthopedic surgeries.