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INCIDENCE OF AND RISK FACTORS FOR SURGICAL-SITE INFECTION IN A PERUVIAN HOSPITAL Clinical Research and Pharmacovigilance Program Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh

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Page 1: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

INCIDENCE OF AND RISK FACTORS FOR SURGICAL-

SITE INFECTION IN A PERUVIAN HOSPITAL

Clinical Research and Pharmacovigilance Program

Christine Daquiado MD, Denzil Daquiado MD,

Petra Wallig RN, Sheila Hamak MD,Christine Gison RPh, Leane Casiding RPh

Research Program Director: Dr. Peivand Pirouzi

Page 2: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD,

Christine Gison RPh, Leane Casiding RPhResearch Program Director: Dr. Peivand Pirouzi

Page 3: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

INTRODUCTION & OBJECTIVE

Page 4: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

STUDY DESIGN

Page 5: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

An INFECTION CONTROL COMMITTEE was created. • But no active

surveillance for infections was being performed on a regular basis

INCLUSION AND EXCLUSION CRITERIA

Two (2) physicians, who

were specifically

trained for this study,

interviewed and closely

observed the patients during

their hospitalization.

Page 6: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

An INFECTION CONTROL COMMITTEE was created. • But no active

surveillance for infections was being performed on a regular basis

INCLUSION AND EXCLUSION CRITERIA

Two (2) physicians, who

were specifically

trained for this study,

interviewed and closely

observed the patients during

their hospitalization.

Page 7: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

INCLUSION AND EXCLUSIONCRITERIA

INCLUSION EXCLUSIONPatients >14 years old undergoing abdominal surgery who consented.

Patient who have undergone surgical interventions at another hospital or who died or were transferred to another hospital within 24 hrs after surgery

Page 8: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

An INFECTION CONTROL COMMITTEE was created. • But no active

surveillance for infections was being performed on a regular basis

INCLUSION AND EXCLUSION CRITERIA

Two (2) physicians, who

were specifically

trained for this study,

interviewed and closely

observed the patients during

their hospitalization.

Page 9: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

Clinical charts were

systematically reviewed and, if necessary, the medical staff of the

patient were interviewed

Data regarding SSI were obtained.

CDC definition for SSI and

other nosocomial

infections were followed to detect all

postoperative nosocomial infections

Page 10: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

Clinical charts were

systematically reviewed and, if necessary, the medical staff of the

patient were interviewed

Data regarding SSI were obtained.

CDC definition for SSI and

other nosocomial

infections were followed to detect all

postoperative nosocomial infections

Page 11: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

DATA COLLECTION

INPATIENT OUTPATIENTClinical evaluation during their hospitalization and until 30 days after surgical intervention

Clinical evaluation through telephone contact or chart review when patients was discharged prior to the 30 days

Page 12: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

Clinical charts were

systematically reviewed and, if necessary, the medical staff of the

patient were interviewed

Data regarding SSI were obtained.

CDC definition for SSI and

other nosocomial

infections were followed to detect all

postoperative nosocomial infections

Page 13: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

CDC CRITERIA FOR SSISuperficial

incisional SSIDeep incisional

SSIOrgan/Space SSI

Infection occurs within 30 days after any NHSN operative procedure (where day 1 = the procedure date)ANDinvolves only skin and subcutaneous tissue of the incision

Infection occurs within 30 or 90 days after the NHSN operative procedure (where day 1 = the procedure date) ANDinvolves deep soft tissues of the incision (e.g., fascial and muscle layers)

Infection occurs within 30 or 90 days after the NHSN operative procedure (where day 1 = the procedure date)ANDinfection involves any part of the body deeper than the fascial/muscle layers, that is opened or manipulated during the operative procedure

Page 14: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

NNIS System risk index was

calculated based on three

risk factors, each worth one

point

A form was devised to collect data

Statistical analysis

Page 15: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RISK FACTORS

Contaminated or dirty surgical wound

American Society of Anaesthesiologist (ASA) score > 2

Duration of surgery > 75th percentile for a specific group of surgical procedures

NNIS System risk index ranges from 0-3

The National Research Council operative-site classification was also used

Page 16: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

NRC OPERATIVE-SITECLASSIFICATION Clean: An uninfected operative wound in which no

inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tracts are not entered.

Clean-Contaminated: Operative wounds in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination

Contaminated: Open, fresh, accidental wounds. Dirty or Infected: Includes old traumatic wounds

with retained devitalized tissue and those that involve existing clinical infection or perforated viscera

Page 17: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

NNIS System risk index was

calculated based on three

risk factors, each worth one

point

A form was devised to collect data

Statistical analysis

Page 18: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

DATA COLLECTION FORM Age Gender Presence of underlying diseases Type of surgery (elective vs emergency) Preoperative stay (in hours) Total length of hospitalization (in days) ASA preoperative assessment score Use and duration of antibiotic prophylaxis Length of surgery (in minutes) 75th percentile duration of every surgical procedure Number of surgical interventions per patient Use and duration of drainage

Page 19: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

METHODS

NNIS System risk index was

calculated based on three

risk factors, each worth one

point

A form was devised to collect data

Statistical analysis

Page 20: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

STATISTICAL ANALYSIS Data were analyzed by a microcomputer using SPSS

software for Windows.

Categorical Variables Chisquare Test Fisher Test

Continuous Variables T-test Mann-Whitnety Test

Pvalue of less than (0.05)were considered significant All two test were two tailed. Relative Risk and Confidence Interval of 95%

Page 21: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

STATISTICAL ANALYSIS

Variables that attained A P value less than 0.001 on univariate analysis were included in stepwise method in multivariate analysis

All participants were requested for oral consent

Page 22: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULTS & DISCUSSION

Page 23: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULTS OF RESEARCH

N= 468 consecutive abdominal interventions were evaluated.

Majority male (average age of 37.2), 59.8 % were men.

Cases were grouped by wound classification

7.7% clean 14.7 % clean-contaminated 39.5% contaminated 38% dirty procedures

Page 24: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULTS OF RESEARCH Univariate analysis = age, gender emergency

procedures were not associated with SSI. Multivariate Analysis The incidence rate of SSI differed by wound

classification 13.5% contaminated 47.2% for dirty wounds (p<.001) Longer the procedure the increases chances of

Surgical Site Infection. A marked increase in the incidence of SSI and in RR

to develop SSI was observed at the NNI (National Nosocomial Infection) System risk index increased.

Page 25: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULT OF STATISTICAL ANALYSIS

Ho : Null Hypothesis There is no relationship between the Incidence and Riskfactors for surgical site infections in a Peruvian Hospital

Ha :Alternative Hypothesis There is a relationship between the Incidence and Risk factors for surgical site infections in a Peruvian Hospital

Page 26: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULT OF STATISTICAL ANALYSIS There is a relationship between the

Incidence and Risk factors for surgical site infections in a Peruvian Hospital

CI of 95% and pvalue of <0.001) Longer the procedure the increases

chances of Surgical Site Infection. A marked increase in the incidence of SSI

and in RR to develop SSI was observed at the NNI (National Nosocomial Infection) System risk index increased

Page 27: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

RESULT OF RESEARCH

Page 28: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

CONCLUSION

Page 29: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

CONCLUSION

SSI is a major problem in the hospital, which has a higher IR (especially for clean interventions) than those of developed countries. In developing countries, prevention of SSI should include active surveillance and interventions targeting modifiable risk factors.

Page 30: Pharmacovigilance Presentation Workshop - Christine Daquiado MD, Denzil Daquiado MD, Petra Wallig RN, Sheila Hamak MD, Christine Gison RPh, Leane Casiding RPh, Professor Peivand Pirouzi

Refrences

Hernandez K, Ramos E, Seas C, Henostroza G, Gotuzzo E. Incidence of and risk factors for surgical-site infections in a Peruvian hospital. Infection Control and Hospital Epidemiology, 2005: 473-477