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Poor enrollment, inability to achieve required number of subjects
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| Name | Class |
|---|---|
| Stryker Nordic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine gluconate vaginal scrub and cloth | Experimental | Patients will have 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 |
|
| Standard Treatment | Active Comparator | Patients who are not in the intervention arm will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine gluconate cloth | Drug | applied to their abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Maternal Complications or Interventions | up to 6 weeks postpartum | |
| Number of Participants With Neonatal ICU Admissions | Number of participants with newborn with neonatal ICU admissions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bianco, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27583685 | Background | Ahmed MR, Aref NK, Sayed Ahmed WA, Arain FR. Chlorhexidine vaginal wipes prior to elective cesarean section: does it reduce infectious morbidity? A randomized trial. J Matern Fetal Neonatal Med. 2017 Jun;30(12):1484-1487. doi: 10.1080/14767058.2016.1219996. Epub 2016 Sep 1. | |
| 28796683 | Background | Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167. |
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Recruitment and enrollment occurred between Oct 2018 and Feb 2021 at Mount Sinai Hospital's Labor and Delivery floor
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
up to 6 weeks postpartum
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicola Tavella | Icahn School of Medicine at Mount Sinai | 212-241-3888 | nicola.tavella@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 | Mar 11, 2022 | Jan 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| 4% Chlorhexidine gluconate vaginal scrub | Drug | applied as a vaginal cleanse in the operating room prior to cesarean section |
|
| up to 6 weeks postpartum |
| Maternal Length of Stay | up to 6 weeks postpartum |
| Number of Participants With Readmissions | up to 6 weeks postpartum |
| Estimated Blood Loss | Day 1 |
| Length of Time From Incision to Delivery | Day 1 |
| Length of Operation | Day 1 |
| 15695981 | Background | Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010. |
| 20054046 | Background | Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. |
| 32580252 | Derived | Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5. |
| 32335895 | Derived | Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7. |
| withdrawn due to vaginal delivery |
|
| Age < 18 |
|
| No Trial of Labor |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| Secondary | Number of Participants With Maternal Complications or Interventions | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Neonatal ICU Admissions | Number of participants with newborn with neonatal ICU admissions | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Secondary | Maternal Length of Stay | Posted | Mean | Standard Deviation | days | up to 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Readmissions | Posted | Count of Participants | Participants | up to 6 weeks postpartum |
|
|
|
| Secondary | Estimated Blood Loss | Posted | Mean | Standard Deviation | mL | Day 1 |
|
|
|
| Secondary | Length of Time From Incision to Delivery | Data not collected | Posted | Day 1 |
|
|
| Secondary | Length of Operation | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 160 |
| 0 |
| 160 |
| 0 |
| 160 |
| EG001 | 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 | 0 | 159 | 0 | 159 | 0 | 159 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| 91+ minutes |
|