Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor (PRACTICAL)
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|ClinicalTrials.gov Identifier: NCT03423147|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : March 21, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section Surgical Site Infection||Drug: 2% chlorhexidine gluconate cloth Drug: 4% Chlorhexidine gluconate vaginal scrub||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Gluconate Cloth and Chlorhexidine Gluconate Vaginal Scrub Reduces Infectious Morbidity in Patients Undergoing Cesarean Section After Labor|
|Anticipated Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Chlorhexidine gluconate vaginal scrub and cloth
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
Drug: 2% chlorhexidine gluconate cloth
applied to their abdomen
Other Name: 2% Chloraprep solutionDrug: 4% Chlorhexidine gluconate vaginal scrub
applied as a vaginal cleanse in the operating room prior to cesarean section
Active Comparator: Standard Treatment
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.
Drug: 2% chlorhexidine gluconate cloth
applied to their abdomen
Other Name: 2% Chloraprep solution
- Rate of surgical site infection [ Time Frame: 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.
- Number of maternal complications or interventions [ Time Frame: up to 6 weeks postpartum ]
- Number of neonatal ICU admissions [ Time Frame: up to 6 weeks postpartum ]
- Maternal length of stay [ Time Frame: up to 6 weeks postpartum ]
- Number of readmissions [ Time Frame: up to 6 weeks postpartum ]
- Estimated blood loss [ Time Frame: Day 1 ]
- Length of time from incision to delivery [ Time Frame: Day 1 ]
- Length of operation [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423147
|Contact: Angela Bianco, MDemail@example.com|
|Contact: Patricia Rekawek, MDfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Not yet recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Angela Bianco, MD|
|Principal Investigator:||Angela Bianco, MD||Icahn School of Medicine at Mount Sinai|