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

1. Clinical Research and
Pharmacovigilance Program
Christine Daquiado MD, Denzil Daquiado MD,
PetraWallig RN, Sheila Hamak MD,
Christine Gison RPh, Leane Casiding RPh
Research Program Director: Dr. Peivand Pirouzi

2. Christine Daquiado MD, Denzil Daquiado MD,
PetraWallig RN, Sheila Hamak MD,
Christine Gison RPh, Leane Casiding RPh
Research Program Director: Dr. Peivand Pirouzi

3. INTRODUCTION &
OBJECTIVE

4. STUDY DESIGN

5. 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.

6. 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.

7. INCLUSION EXCLUSION
Patients >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

8. 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.

9. 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

10. 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

11. INPATIENT OUTPATIENT
Clinical 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

12. 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

13. Superficial incisional SSI Deep incisional SSI Organ/Space SSI
Infection occurs within 30
days after any NHSN
operative procedure (where
day 1 = the procedure date)
AND
involves 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)
AND
involves 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)
AND
infection involves any part
of the body deeper than
the fascial/muscle layers,
that is opened or
manipulated during the
operative procedure

14. NNIS System risk
index was
calculated based on
three risk factors,
each worth one
point
A form was devised
to collect data
Statistical analysis

15.  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

16.  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

17. NNIS System risk
index was
calculated based on
three risk factors,
each worth one
point
A form was devised
to collect data
Statistical analysis

18.  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

19. NNIS System risk
index was
calculated based on
three risk factors,
each worth one
point
A form was devised
to collect data
Statistical analysis

20.  Data were analyzed by a microcomputer using SPSS
software for Windows.
 CategoricalVariables
 ChisquareTest
 FisherTest
 ContinuousVariables
 T-test
 Mann-WhitnetyTest
 Pvalue of less than (0.05)were considered significant
 All two test were two tailed.
 Relative Risk and Confidence Interval of 95%

21.  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

22. RESULTS & DISCUSSION

23.  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

24.  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.

25. 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

26.  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

28. CONCLUSION

29.  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.

30.  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