Prevention of Surgical Site Infection After Cesarean Delivery
| Status: | Withdrawn |
|---|---|
| Conditions: | Infectious Disease, Hospital |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | February 2017 |
Chlorhexidine-Alcohol Vs. Povidone-Iodine for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Trial
There are approximately 1.4 million cesarean deliveries in the United States each year, and
an average of 1250 elective cesarean deliveries each year at the Brigham and Women's
Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH,
approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI
is associated with significant morbidity and increased cost of care, numerous guidelines
exist to guide preoperative administration of prophylactic antibiotics. However, there are
no recommendations for the choice of antiseptic solution for prevention of SSI. Among the
currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease
SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to
minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery.
Many institutions use povidone-iodine, another antisepsis preparation that does not require
the mandatory drying time. Our randomized study aims to compare the incidence of SSI in
patients receiving either CA or PI during elective cesarean delivery, and we hypothesize
that CA would be associated with a lower incidence of SSI.
an average of 1250 elective cesarean deliveries each year at the Brigham and Women's
Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH,
approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI
is associated with significant morbidity and increased cost of care, numerous guidelines
exist to guide preoperative administration of prophylactic antibiotics. However, there are
no recommendations for the choice of antiseptic solution for prevention of SSI. Among the
currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease
SSI in non-obstetric surgeries. However, the time required for CA to dry (~ 3 min) to
minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery.
Many institutions use povidone-iodine, another antisepsis preparation that does not require
the mandatory drying time. Our randomized study aims to compare the incidence of SSI in
patients receiving either CA or PI during elective cesarean delivery, and we hypothesize
that CA would be associated with a lower incidence of SSI.
This study will be conducted over three years with an estimated sample size of 4500
patients. Prior to enrollment of study subjects, each year will be divided into 3-month
blocks and each block will be assigned one of the two study antiseptic solutions — 2%
chlorhexidine gluconate in 70% isopropyl alcohol (CA) or 10% Povidone-Iodine (PI) — in an
alternating manner. All patients undergoing elective cesarean deliveries during a block will
receive the same preoperative skin preparation, in concordance with guidelines for its use.
The block assignments will alternate within each year and the order will be reversed after
one year to minimize or eliminate seasonal variation in skin infection rates. All patients
will receive routine history and physical examination, blood tests, pre-procedure bathing
instructions, and preoperative body hair clipping as desired by their primary obstetric
provider. Age, body mass index (BMI), gestational age, history of smoking, previous
abdominal surgery, number of pregnancies, and live births will be documented before entry
into the study. Eligible patients will receive antibiotic prophylaxis with weight-based
cefazolin within 60 min before skin incision. We will collect data on preoperative
preparation of the surgical site (clipping vs. shaving), type of skin and uterine incision,
method of fascia and skin closure, duration of the procedure, use of postoperative
antibiotics, and adverse reactions to the skin preparation. The primary endpoint for this
study will be any SSI diagnosed within 30 days of cesarean delivery. Our secondary outcomes
will be the type of SSI (based on the Center for Disease Control infection classification)
and the time to diagnosis of SSI.
The Infectious Disease department at BWH will perform the surveillance for SSI/endometritis.
This team will be blinded to the choice of anti-sepsis preparation during the study period.
Briefly, surveillance will include daily, weekly, monthly, and quarterly reviews of data.
The infectious disease team will perform a daily review of microbiology results for positive
wound and blood cultures, and assess whether the patient had cesarean section within 30 days
prior to cultures. On a weekly basis, a report of obstetric patients readmitted within 30
days will be generated, and patients will be selected with an admitting diagnosis consistent
with infection in the setting of a history of recent cesarean delivery. Each month, a report
of patients will be generated with ICD-9 discharge code for cesarean section as well as
ICD-9 codes for other complications of obstetrical surgical wound and major puerperal
infection. Post-cesarean delivery patients receiving antibiotics for at least 2 days after
the first postoperative day, and those that receive antibiotics during readmission will also
be identified and recorded. During every quarter, the number of elective cesarean deliveries
performed will be quantified, and the incidence of specific sub-types of SSI (superficial,
deep, organ space/endometritis) will be documented. In addition to inpatient surveillance,
the electronic clinic records for all patients will be reviewed, and data will be recorded
for any SSI that is diagnosed and treated on an outpatient basis. Documentation from
discharge to the six-week postpartum visit will be reviewed to ensure data fidelity, but
only infections that occur within 30 days of cesarean delivery will be included in the final
analyses. Active SSI will be treated according to prevailing guidelines.
patients. Prior to enrollment of study subjects, each year will be divided into 3-month
blocks and each block will be assigned one of the two study antiseptic solutions — 2%
chlorhexidine gluconate in 70% isopropyl alcohol (CA) or 10% Povidone-Iodine (PI) — in an
alternating manner. All patients undergoing elective cesarean deliveries during a block will
receive the same preoperative skin preparation, in concordance with guidelines for its use.
The block assignments will alternate within each year and the order will be reversed after
one year to minimize or eliminate seasonal variation in skin infection rates. All patients
will receive routine history and physical examination, blood tests, pre-procedure bathing
instructions, and preoperative body hair clipping as desired by their primary obstetric
provider. Age, body mass index (BMI), gestational age, history of smoking, previous
abdominal surgery, number of pregnancies, and live births will be documented before entry
into the study. Eligible patients will receive antibiotic prophylaxis with weight-based
cefazolin within 60 min before skin incision. We will collect data on preoperative
preparation of the surgical site (clipping vs. shaving), type of skin and uterine incision,
method of fascia and skin closure, duration of the procedure, use of postoperative
antibiotics, and adverse reactions to the skin preparation. The primary endpoint for this
study will be any SSI diagnosed within 30 days of cesarean delivery. Our secondary outcomes
will be the type of SSI (based on the Center for Disease Control infection classification)
and the time to diagnosis of SSI.
The Infectious Disease department at BWH will perform the surveillance for SSI/endometritis.
This team will be blinded to the choice of anti-sepsis preparation during the study period.
Briefly, surveillance will include daily, weekly, monthly, and quarterly reviews of data.
The infectious disease team will perform a daily review of microbiology results for positive
wound and blood cultures, and assess whether the patient had cesarean section within 30 days
prior to cultures. On a weekly basis, a report of obstetric patients readmitted within 30
days will be generated, and patients will be selected with an admitting diagnosis consistent
with infection in the setting of a history of recent cesarean delivery. Each month, a report
of patients will be generated with ICD-9 discharge code for cesarean section as well as
ICD-9 codes for other complications of obstetrical surgical wound and major puerperal
infection. Post-cesarean delivery patients receiving antibiotics for at least 2 days after
the first postoperative day, and those that receive antibiotics during readmission will also
be identified and recorded. During every quarter, the number of elective cesarean deliveries
performed will be quantified, and the incidence of specific sub-types of SSI (superficial,
deep, organ space/endometritis) will be documented. In addition to inpatient surveillance,
the electronic clinic records for all patients will be reviewed, and data will be recorded
for any SSI that is diagnosed and treated on an outpatient basis. Documentation from
discharge to the six-week postpartum visit will be reviewed to ensure data fidelity, but
only infections that occur within 30 days of cesarean delivery will be included in the final
analyses. Active SSI will be treated according to prevailing guidelines.
Inclusion Criteria:
- All patients scheduled for elective cesarean delivery
Exclusion Criteria:
- Allergy to either of the antiseptic preparations
- Ongoing active skin or systemic infection
- Pre-operative antibiotic therapy for non-surgical reasons
- Those unable to receive antibiotic prophylaxis
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