Chlorhexidine Gluconate Cloths, Endometritis, Infection; Cesarean Section, Infectious Morbidity, Surgical Site Infections
Conditions
Keywords
cesarean section, chlorhexidine gluconate, CHG, surgical site infection, obstetrics, infection prevention, pregnancy
Brief summary
The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site infections, endometritis). The study will be offered to women who present for a scheduled primary or repeat cesarean section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. This study intends to show that the use of 2% CHG cloths prior to cesarean section will reduce the rate of surgical site infections.
Detailed description
Chlorhexidine is a sterile, germ-free solution, which is regularly used to clean the skin immediately before surgery and works by killing or preventing the growth or spread of bacteria. Data exists in both the orthopedic and cardiac literature to show that an additional preoperative use of chlorhexidine further reduces the risk of post procedure infections. Limited data exists regarding the use of a preoperative use of chlorhexidine in patients undergoing Obstetric or Gynecologic procedures and there is no wash or cloth used prior to cesarean section as a standard of care. The hope for this study is to identify if an additional preoperative chlorhexidine wash will further decrease or prevent infection in women who deliver their babies via cesarean section. All patients with a scheduled cesarean section surgery will be approached for enrollment during their pre-admission testing visit on the labor floor 2 days before the scheduled cesarean section, a visit that is standard procedure for this surgery. Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the eligible women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths (a fragrance free cleansing cloths) on the body the night before and the morning of their scheduled procedure. Participants will be blinded to the arm in which they have been assigned. The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum endometritis, which is an infection or inflammation of the endometrium (the inner lining of the uterus).
Interventions
DEVICE2% chlorhexidine gluconate (CHG) cloth
administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
DEVICEPlacebo cloth
administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women * \> 24 weeks gestation * scheduled for a primary or repeat cesarean section
Exclusion criteria
* allergy to chlorhexidine * unplanned or emergency cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incisional SSI | at 6 weeks | Number of participants with Incisional Surgical Site Infection (SSI) |
| Number of Adherent Participants With Incisional SSI | at 6 weeks | Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks. |
| Number of Participants With Endometritis | at 6 weeks | Number of participants with endometritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Maternal Complications | up to 6 weeks | Number of participants with maternal complications |
| Number of Participants With Maternal Readmissions | up to 6 weeks | Number of participants with hospital readmission for wound complication |
| Incidence of Neonatal ICU Admissions | up to 6 weeks | — |
| Maternal Length of Stay | at 6 weeks | Length of stay (index hospitalization) |
Countries
United States
Participant flow
Pre-assignment details
1356 were enrolled, 14 did not undergo procedure at Sinai, leaving 1342 participants (672 in experimental group and 670 in placebo group) that continued on the study.
Participants by arm
| Arm | Count |
|---|---|
| CHG Cloth 2% chlorhexidine gluconate (CHG) cloth: administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery. | 682 |
| Placebo Cloth Placebo cloth: administration of a fragrance free cleansing cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery. | 674 |
| Total | 1,356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Delivered outside of Sinai | 1 | 1 |
| Overall Study | Delivered vaginally | 9 | 3 |
| Overall Study | Lost to follow up after C-Section | 10 | 23 |
Baseline characteristics
| Characteristic | Placebo Cloth | CHG Cloth | Total |
|---|---|---|---|
| Age, Continuous | 35.1 years STANDARD_DEVIATION 5 | 35.1 years STANDARD_DEVIATION 5 | 35.1 years STANDARD_DEVIATION 5 |
| Asthma | 28 Participants | 47 Participants | 75 Participants |
| Cholestasis | 7 Participants | 8 Participants | 15 Participants |
| Chronic Hypertension | 26 Participants | 23 Participants | 49 Participants |
| Estimated Blood loss | 717.5 mL | 719.5 mL | 718.5 mL |
| Gestational Diabetes | 57 Participants | 69 Participants | 126 Participants |
| Gestational Hypertension | 18 Participants | 17 Participants | 35 Participants |
| Length of procedure | 62.0 min | 62.0 min | 62.0 min |
| Preeclampsia | 13 Participants | 8 Participants | 21 Participants |
| Pregestational Diabetes | 13 Participants | 9 Participants | 22 Participants |
| Preincision Prophylactic Antibiotics Cefazolin | 648 Participants | 645 Participants | 1293 Participants |
| Preincision Prophylactic Antibiotics Clindamycin/gentamicin | 12 Participants | 14 Participants | 26 Participants |
| Primiparous | 236 Participants | 248 Participants | 484 Participants |
| Private Insurance | 577 Participants | 604 Participants | 1181 Participants |
| Race/Ethnicity, Customized Black or African American | 60 Participants | 66 Participants | 126 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 121 Participants | 113 Participants | 234 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 77 Participants | 67 Participants | 144 Participants |
| Race/Ethnicity, Customized White | 416 Participants | 436 Participants | 852 Participants |
| Repeat Cesarean Delivery | 394 Participants | 387 Participants | 781 Participants |
| Sex: Female, Male Female | 674 Participants | 682 Participants | 1356 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin Closure Type Staples | 58 Participants | 56 Participants | 114 Participants |
| Skin Closure Type Subcuticular suture | 612 Participants | 616 Participants | 1228 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 672 | 0 / 670 |
| other Total, other adverse events | 0 / 672 | 0 / 670 |
| serious Total, serious adverse events | 0 / 672 | 0 / 670 |
Outcome results
Primary
Number of Adherent Participants With Incisional SSI
Among those with full adherence to the protocol and who were available for assessment at 6 weeks. Adherence to the protocol was assessed in the following 2 ways: evaluation of returned packages on the day of surgery and report ascertained by phone interview at 2 weeks.
Time frame: at 6 weeks
Population: participants with full adherence to protocol and available for assessment at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHG Cloth | Number of Adherent Participants With Incisional SSI | 10 Participants |
| Placebo Cloth | Number of Adherent Participants With Incisional SSI | 17 Participants |
Primary
Number of Participants With Endometritis
Number of participants with endometritis
Time frame: at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHG Cloth | Number of Participants With Endometritis | 0 Participants |
| Placebo Cloth | Number of Participants With Endometritis | 1 Participants |
Primary
Number of Participants With Incisional SSI
Number of participants with Incisional Surgical Site Infection (SSI)
Time frame: at 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHG Cloth | Number of Participants With Incisional SSI | 17 Participants |
| Placebo Cloth | Number of Participants With Incisional SSI | 24 Participants |
Secondary
Incidence of Neonatal ICU Admissions
Time frame: up to 6 weeks
Population: Data not collected
Secondary
Maternal Length of Stay
Length of stay (index hospitalization)
Time frame: at 6 weeks
Population: data for participants who were hospitalized
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CHG Cloth | Maternal Length of Stay | 3.0 days |
| Placebo Cloth | Maternal Length of Stay | 3.0 days |
Secondary
Number of Participants With Maternal Complications
Number of participants with maternal complications
Time frame: up to 6 weeks
Population: Data results only for those participants who underwent C-Section at Sinai
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CHG Cloth | Number of Participants With Maternal Complications | Erythema at operative site | 16 Participants |
| CHG Cloth | Number of Participants With Maternal Complications | Skin Separation | 19 Participants |
| CHG Cloth | Number of Participants With Maternal Complications | Drainage | 21 Participants |
| CHG Cloth | Number of Participants With Maternal Complications | Fever | 4 Participants |
| CHG Cloth | Number of Participants With Maternal Complications | Hematoma | 1 Participants |
| CHG Cloth | Number of Participants With Maternal Complications | Seroma | 2 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Hematoma | 5 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Erythema at operative site | 16 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Fever | 2 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Skin Separation | 23 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Seroma | 0 Participants |
| Placebo Cloth | Number of Participants With Maternal Complications | Drainage | 16 Participants |
Secondary
Number of Participants With Maternal Readmissions
Number of participants with hospital readmission for wound complication
Time frame: up to 6 weeks
Population: Data results only for those participants who underwent C-Section at Sinai. unable to obtain data for 2 participants in placebo cloth arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHG Cloth | Number of Participants With Maternal Readmissions | 5 Participants |
| Placebo Cloth | Number of Participants With Maternal Readmissions | 3 Participants |