| Protocol No: | ECCT/22/09/03 | Date of Protocol: | 09-09-2022 |
| Study Title: |
EFFECTIVENESS OFSINGLE-DOSE ANTIBIOTIC USE IN ELECTIVE CAESAREANSECTION IN PREVENTION OF SURGICAL SITE INFECTION AT JARAMOGI
OGINGA ODINGA TEACHING AND REFERRAL HOSPITAL, KISUMU COUNTY,KENYA: A RANDOMIZED CONTROL TRIAL.
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| Study Objectives: |
Objectives of the study
BROAD OBJECTIVE
To assess the effectiveness of single dose antibiotic use in elective caesarean section for SSI prevention.
SPECIFIC OBJECTIVE
1. To compare the occurrence of post CS surgical site infection when using extended antibiotics versus single dose prophylactic antibiotics.
2. To determine patient factors associated with surgical site infection among women undergoing elective caesarean section.
3. To determine the rational use of antibiotics among women randomized for single dose prophylactic antibiotics in Elective caesarean section
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| Laymans Summary: | This study aims to compare two groups of women who are scheduled to undergo elective caesarean section at JOOTRH. One group will be randomized to get extended dose of antibiotics while the othr group will be randomized to get single dose of antbiotics. The two gruops will be closely followed up after discharge on day 7 , 14 and 28 and surgical site monitored for any infections. This comes after the realization that despite literature to support use of single dose antibiotics many medical practioners are still reluctant and always give extended doses of antibitics to this group of patients. |
| Abstract of Study: |
ABSTRACT
One-third to two-thirds of operated patients in low-income countries acquire surgical site infection (SSI),
which is nine times higher when compared to developed countries. Caesarean section (CS) account for
most of recorded cases of SSI compared to other surgical procedures both in developed and low-income
countries. In African countries, women giving birth still face substantial risks to their own life and that of
their baby and sepsis remains the greatest contributor to maternal morbidity and mortality. Even though
the impact of antibiotic prophylaxis in both emergency and elective caesarean sections has been
highlighted in previous studies, it is not clear whether there exists any significant difference in prevention
of surgical site infection when single dose compared to extended dose antibiotic is used. This study aims
to evaluate differences in occurrence of surgical site infection when extended versus single dose
antibiotics are provided among women undergoing elective caesarean section. The specific objectives of
this study are (i) to compare the occurrence of post caesarean SSI when using extended versus single dose
prophylactic antibiotics. (ii) to determine patient factors associated with surgical site infection among
women undergoing elective caesarean section. (iii) to determine the rational use of antibiotics among
women randomized for single dose prophylactic antibiotics in Elective caesarean section. This will be an
institutional based, un-blinded randomized control study to be carried out at JaramogiOgingaOdinga
Teaching and Referral Hospital (JOOTRH), Kisumu County, Kenya because (i) the hospital has a 600-
bed capacity making it be among those hospitals with higher projected rates of SSIs. (ii)Approximately
300 caesarean sections are carried out quarter yearly. (iii)The hospital has no existing antibiotic protocol
for use in women undergoing caesarean deliveries. (iv) Antibiotic use in surgical patients is high in
JOOTRH (v) The number of reported Surgical site infections are high at JOOTRH. The study population
will comprise of women aged 18 – 49 years admitted for elective CS at JOOTRH .150 women scheduled
for elective caesarean section will be randomized in two groups, namely the control group and the
intervention group. Those in control group will get extended doses of antibiotics while those in
intervention group shall get single dose antibiotic. Both groups will be followed up for 28 days for signs
and symptoms off SSIs using a close-ended questionnaire on days 2, 14 and 28 after surgery. Collected
data will be summarized using frequency counts and percentages. Inferential analysis will be employed to
analyze the collected data. Pearson’s Chi-square test of independence and Fisher’s exact test will be used
to assess the association of variables. All covariates with p-value <=0.05 at bivariate analysis will be
included in multivariate logistic regression. The expected outcome of the study is to provide data that will
be used in formulating protocol on antibiotic use in caesarean section in JOOTRH. This study is
envisioned to be a preamble to even a wider study on caesarean section care of women in western Kenya.
The participants will not directly benefit from the study results since by the time of analysis all of them
will have exited the study.
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