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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG cloth | Experimental | 2% chlorhexidine gluconate (CHG) cloth |
|
| Placebo cloth | Placebo Comparator | A fragrance free cleansing cloth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine gluconate (CHG) cloth | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incisional SSI | Number of participants with Incisional Surgical Site Infection (SSI) | at 6 weeks |
| 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. | at 6 weeks |
| Number of Participants With Endometritis | Number of participants with endometritis | at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Maternal Complications | Number of participants with maternal complications | up to 6 weeks |
| Incidence of Neonatal ICU Admissions | up to 6 weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Stone, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo Cloth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Maternal age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Incisional SSI | Number of participants with Incisional Surgical Site Infection (SSI) | Posted | Count of Participants | Participants | at 6 weeks |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limitations included the lower than anticipated rate of SSIs after scheduled cesarean deliveries, suggesting the possibility that the study was underpowered for the primary outcome. High rate of private insurance may limit generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne Stone | Icahn School of Medicine at Mount Sinai | 212-241-5681 | joanne.stone@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Aug 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D013530 | Surgical Wound Infection |
| D004716 | Endometritis |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo cloth | Device | 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. |
|
|
| Maternal Length of Stay | Length of stay (index hospitalization) | at 6 weeks |
| Number of Participants With Maternal Readmissions | Number of participants with hospital readmission for wound complication | up to 6 weeks |
| Lost to follow up after C-Section |
|
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.
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Private Insurance | Count of Participants | Participants |
|
| Chronic Hypertension | Count of Participants | Participants |
|
| Pregestational Diabetes | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Primiparous | Count of Participants | Participants |
|
| Repeat Cesarean Delivery | Count of Participants | Participants |
|
| Gestational Hypertension | Count of Participants | Participants |
|
| Gestational Diabetes | Count of Participants | Participants |
|
| Preeclampsia | Count of Participants | Participants |
|
| Cholestasis | Count of Participants | Participants |
|
| Estimated Blood loss | Data results only for those participants who underwent C-Section at Sinai | Median | Inter-Quartile Range | mL |
|
| Length of procedure | Data results only for those participants who underwent C-Section at Sinai | Median | Inter-Quartile Range | min |
|
| Preincision Prophylactic Antibiotics | Data results only for those participants who underwent C-Section at Sinai | Count of Participants | Participants |
|
| Skin Closure Type | Data results only for those participants who underwent C-Section at Sinai | Count of Participants | Participants |
|
|
|
| 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. | participants with full adherence to protocol and available for assessment at 6 weeks | Posted | Count of Participants | Participants | at 6 weeks |
|
|
|
| Primary | Number of Participants With Endometritis | Number of participants with endometritis | Posted | Count of Participants | Participants | at 6 weeks |
|
|
|
| Secondary | Number of Participants With Maternal Complications | Number of participants with maternal complications | Data results only for those participants who underwent C-Section at Sinai | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| Secondary | Incidence of Neonatal ICU Admissions | Data not collected | Posted | up to 6 weeks |
|
|
| Secondary | Maternal Length of Stay | Length of stay (index hospitalization) | data for participants who were hospitalized | Posted | Median | Inter-Quartile Range | days | at 6 weeks |
|
|
|
| Secondary | Number of Participants With Maternal Readmissions | Number of participants with hospital readmission for wound complication | Data results only for those participants who underwent C-Section at Sinai. unable to obtain data for 2 participants in placebo cloth arm | Posted | Count of Participants | Participants | up to 6 weeks |
|
|
|
| 0 |
| 672 |
| 0 |
| 672 |
| 0 |
| 672 |
| EG001 | 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. | 0 | 670 | 0 | 670 | 0 | 670 |
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| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014591 | Uterine Diseases |
| D000091662 | Genital Diseases |
| Drainage |
|
| Fever |
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| Hematoma |
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| Seroma |
|