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

• ClinicalTrials.gov Identifier: NCT03423147
• Recruitment Status: Terminated
• First Posted: February 6, 2018
• Results First Posted: March 23, 2023
• Last Update Posted: March 23, 2023
• Sponsor: Angela Bianco
• Collaborator: Stryker Nordic
• Information provided by (Responsible Party): Angela Bianco, Icahn School of Medicine at Mount Sinai

Study Description

Brief Summary:

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; Nosocomial Infection	Drug: 2% chlorhexidine gluconate cloth; Drug: 4% Chlorhexidine gluconate vaginal scrub	Phase 2

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 5, 2018
• Actual Primary Completion Date: February 11, 2021
• Actual Study Completion Date: February 11, 2021

Arms and Interventions

Arm	Intervention/treatment
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 solution; Drug: 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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With 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.

Secondary Outcome Measures :

1. Number of Participants With Maternal Complications or Interventions [ Time Frame: up to 6 weeks postpartum ]
2. Number of Participants With Neonatal ICU Admissions [ Time Frame: up to 6 weeks postpartum ]
   Number of participants with newborn with neonatal ICU admissions
3. Maternal Length of Stay [ Time Frame: up to 6 weeks postpartum ]
4. Number of Participants With Readmissions [ Time Frame: up to 6 weeks postpartum ]
5. Estimated Blood Loss [ Time Frame: Day 1 ]
6. Length of Time From Incision to Delivery [ Time Frame: Day 1 ]
7. Length of Operation [ Time Frame: Day 1 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Women at > 24 weeks gestation who are admitted in labor or admitted for induction of labor at Mount Sinai Hospital

Exclusion Criteria:

• Allergy to chlorhexidine
• Unplanned or emergency cesarean section
• Women at <24 weeks gestation
• Estimated fetal weight <500 grams
• Fetal face presentation regardless of gestational age.

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Angela Bianco

Stryker Nordic

Investigators

• Principal Investigator: Angela Bianco, MD; Icahn School of Medicine at Mount Sinai

  Study Documents (Full-Text)

Documents provided by Angela Bianco, Icahn School of Medicine at Mount Sinai:

Study Protocol and Statistical Analysis Plan  [PDF] March 11, 2022

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Angela Bianco, Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03423147
• Other Study ID Numbers: GCO 17-1235
• First Posted: February 6, 2018
• Results First Posted: March 23, 2023
• Last Update Posted: March 23, 2023
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Bianco, Icahn School of Medicine at Mount Sinai:

Cesarean section; Labor; Surgical Site Infections; Chlorhexidine gluconate

Additional relevant MeSH terms:

Infections; Communicable Diseases; Surgical Wound Infection; Cross Infection; Disease Attributes; Pathologic Processes; Wound Infection; Postoperative Complications; Iatrogenic Disease; Chlorhexidine; Chlorhexidine gluconate; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents