Trial Outcomes & Findings for Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor (NCT NCT03423147)

NCT ID: NCT03423147

Last Updated: 2023-03-23

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 319 participants
• Primary outcome timeframe: up to 6 weeks postpartum
• Results posted on: 2023-03-23

Participant Flow

Recruitment and enrollment occurred between Oct 2018 and Feb 2021 at Mount Sinai Hospital's Labor and Delivery floor

Participant milestones

Measure	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	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
Overall Study STARTED	160	159
Overall Study COMPLETED	152	150
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	5	8
Overall Study Withdrawal by Subject	1	0
Overall Study withdrawn due to vaginal delivery	1	0
Overall Study Age < 18	1	0
Overall Study No Trial of Labor	0	1

Baseline Characteristics

Preoperative Application of Chlorhexidine to Reduce Infection With Cesarean Section After Labor

Baseline characteristics by cohort

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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	Total n=319 Participants Total of all reporting groups
Age, Continuous	32.01 years STANDARD_DEVIATION 6.10 • n=5 Participants	32.59 years STANDARD_DEVIATION 5.43 • n=7 Participants	32.30 years STANDARD_DEVIATION 5.77 • n=5 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	159 Participants n=7 Participants	319 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	30 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	108 Participants n=7 Participants	206 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	30 Participants n=5 Participants	21 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	67 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	45 Participants n=5 Participants	35 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Number of Participants With Surgical Site Infection	12 Participants	22 Participants

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Number of Participants With Maternal Complications or Interventions	7 Participants	1 Participants

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Number of participants with newborn with neonatal ICU admissions

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Number of Participants With Neonatal ICU Admissions	30 Participants	36 Participants

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Maternal Length of Stay	2.98 days Standard Deviation 1.24	2.93 days Standard Deviation 0.78

SECONDARY outcome

Timeframe: up to 6 weeks postpartum

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Number of Participants With Readmissions	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Estimated Blood Loss	671 mL Standard Deviation 389	670 mL Standard Deviation 391

SECONDARY outcome

Timeframe: Day 1

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1

Outcome measures

Measure	Chlorhexidine Gluconate Vaginal Scrub and Cloth n=160 Participants 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	Standard Treatment n=159 Participants 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
Length of Operation 61-90 minutes	87 Participants	96 Participants
Length of Operation 91+ minutes	27 Participants	17 Participants
Length of Operation 45-60 minutes	46 Participants	46 Participants

Adverse Events

Chlorhexidine Gluconate Vaginal Scrub and Cloth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicola Tavella

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3888

Email: nicola.tavella@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place