Cesarean Section, Nosocomial Infection, Surgical Site Infection
Conditions
Keywords
Cesarean section, Labor, Surgical Site Infections, Chlorhexidine gluconate
Brief summary
Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in surgical patients. In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor. Chlorhexidine, a chemical antiseptic effective on gram positive and gram negative bacteria, reduces skin microflora/colonization but it is not clear if it decreases the risk of SSI. Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. This study intends to evaluate the effectiveness of use of both chlorhexidine gluconate (CHG) wipe and vaginal scrub in reducing SSI in patients undergoing cesarean section that have previously been laboring. Patients will be randomized to one of two groups: wash with both a pre-operative CHG cloth prior to surgery and chlorhexidine gluconate vaginal scrub in addition to standard preoperative scrub as compared to standard preoperative scrub alone.
Detailed description
The study will be offered to women who are admitted to undergo labor at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth with 4% chlorhexidine gluconate vaginal scrub (including standard preoperative care prior to cesarean section) or standard preoperative care. Participants will not be blinded to the arm in which they have been assigned. Researchers will have access to all patients scheduled for delivery at Mount Sinai Medical Center. About 1800 deliveries by cesarean section occur each year at Mount Sinai. Of these, approximately 800 are cesarean sections after failed labor. Assuming a primary outcome rate of 20% in the control arm, a sample size of 329 in each group would give 80% power to detect a 40% reduction in surgical site infection between the active group and control. The aim is to recruit 400 patients per group (for a total of 800 patients) to account for patient drop out or non-compliance. Sage Products, Inc will be providing the CHG cloths. This study intends to show that simultaneous use of 2% CHG cloths and 4% CHG vaginal scrub prior to cesarean section will reduce the rate of SSI in women who have previously been laboring.
Interventions
applied to their abdomen
DRUG4% Chlorhexidine gluconate vaginal scrub
applied as a vaginal cleanse in the operating room prior to cesarean section
Sponsors
Stryker Nordic
Angela Bianco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women at \> 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital
Exclusion criteria
* Allergy to chlorhexidine * Unplanned or emergency cesarean section * Women at \<24 weeks gestation * Estimated fetal weight \<500 grams * Fetal face presentation regardless of gestational age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infection | up to 6 weeks postpartum | Surgical site infection will be a composite of wound infection and postpartum endometritis. Endometritis is defined as postoperative fever of 100.4 °F or more occurring 24 hours after delivery associated with uterine tenderness and persistent foul-smelling lochia, requiring broad-spectrum intravenous antibiotic administration. Wound infection is defined as erythema or wound edge separation with purulent discharge involving the cesarean incision site that requires antibiotic therapy and wound care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Neonatal ICU Admissions | up to 6 weeks postpartum | Number of participants with newborn with neonatal ICU admissions |
| Maternal Length of Stay | up to 6 weeks postpartum | — |
| Number of Participants With Readmissions | up to 6 weeks postpartum | — |
| Number of Participants With Maternal Complications or Interventions | up to 6 weeks postpartum | — |
| Length of Time From Incision to Delivery | Day 1 | — |
| Length of Operation | Day 1 | — |
| Estimated Blood Loss | Day 1 | — |
Countries
United States
Participant flow
Recruitment details
Recruitment and enrollment occurred between Oct 2018 and Feb 2021 at Mount Sinai Hospital's Labor and Delivery floor
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth Patients had a 2% chlorhexidine gluconate cloth applied to their abdomen as well as 4% chlorhexidine gluconate vaginal scrub applied as a vaginal cleanse in the operating room prior to cesarean section
2% chlorhexidine gluconate cloth: applied to their abdomen
4% Chlorhexidine gluconate vaginal scrub: applied as a vaginal cleanse in the operating room prior to cesarean section | 160 |
| Standard Treatment Patients who are not in the intervention arm received the standard of care prior to a cesarean section. In the operating room the patient will receive an abdominal cleanse with 2% Chloraprep solution (2% chlorhexidine gluconate) in addition to routine IV antibiotics.
2% chlorhexidine gluconate cloth: applied to their abdomen | 159 |
| Total | 319 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Age < 18 | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 8 |
| Overall Study | No Trial of Labor | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
| Overall Study | withdrawn due to vaginal delivery | 1 | 0 |
Baseline characteristics
| Characteristic | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment | Total |
|---|---|---|---|
| Age, Continuous | 32.01 years STANDARD_DEVIATION 6.1 | 32.59 years STANDARD_DEVIATION 5.43 | 32.30 years STANDARD_DEVIATION 5.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 108 Participants | 206 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 21 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 16 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 28 Participants | 53 Participants |
| Race (NIH/OMB) More than one race | 45 Participants | 35 Participants | 80 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) White | 64 Participants | 67 Participants | 131 Participants |
| Sex: Female, Male Female | 160 Participants | 159 Participants | 319 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 159 |
| other Total, other adverse events | 0 / 160 | 0 / 159 |
| serious Total, serious adverse events | 0 / 160 | 0 / 159 |
Outcome results
Primary
Number of Participants With Surgical Site Infection
Surgical site infection will be a composite of wound infection and postpartum endometritis. Endometritis is defined as postoperative fever of 100.4 °F or more occurring 24 hours after delivery associated with uterine tenderness and persistent foul-smelling lochia, requiring broad-spectrum intravenous antibiotic administration. Wound infection is defined as erythema or wound edge separation with purulent discharge involving the cesarean incision site that requires antibiotic therapy and wound care.
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Number of Participants With Surgical Site Infection | 12 Participants |
| Standard Treatment | Number of Participants With Surgical Site Infection | 22 Participants |
Secondary
Estimated Blood Loss
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Estimated Blood Loss | 671 mL | Standard Deviation 389 |
| Standard Treatment | Estimated Blood Loss | 670 mL | Standard Deviation 391 |
Secondary
Length of Operation
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Length of Operation | 45-60 minutes | 46 Participants |
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Length of Operation | 61-90 minutes | 87 Participants |
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Length of Operation | 91+ minutes | 27 Participants |
| Standard Treatment | Length of Operation | 45-60 minutes | 46 Participants |
| Standard Treatment | Length of Operation | 61-90 minutes | 96 Participants |
| Standard Treatment | Length of Operation | 91+ minutes | 17 Participants |
Secondary
Length of Time From Incision to Delivery
Time frame: Day 1
Population: Data not collected
Secondary
Maternal Length of Stay
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Maternal Length of Stay | 2.98 days | Standard Deviation 1.24 |
| Standard Treatment | Maternal Length of Stay | 2.93 days | Standard Deviation 0.78 |
Secondary
Number of Participants With Maternal Complications or Interventions
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Number of Participants With Maternal Complications or Interventions | 7 Participants |
| Standard Treatment | Number of Participants With Maternal Complications or Interventions | 1 Participants |
Secondary
Number of Participants With Neonatal ICU Admissions
Number of participants with newborn with neonatal ICU admissions
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Number of Participants With Neonatal ICU Admissions | 30 Participants |
| Standard Treatment | Number of Participants With Neonatal ICU Admissions | 36 Participants |
Secondary
Number of Participants With Readmissions
Time frame: up to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | Number of Participants With Readmissions | 6 Participants |
| Standard Treatment | Number of Participants With Readmissions | 2 Participants |