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

NCT03423147 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: GCO 17-1235
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Surgical Site Infection; Nosocomial Infection

Keywords

Cesarean section; Labor; Surgical Site Infections; Chlorhexidine gluconate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Number of Participants With Maternal Complications or Interventions

  up to 6 weeks postpartum

• Number of Participants With Neonatal ICU Admissions

  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

Study Arms (2)

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

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

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.

Drug: 2% chlorhexidine gluconate cloth

Interventions

2% chlorhexidine gluconate cloth DRUG

applied to their abdomen

Also known as: 2% Chloraprep solution

Chlorhexidine gluconate vaginal scrub and cloth; Standard Treatment

4% Chlorhexidine gluconate vaginal scrub DRUG

applied as a vaginal cleanse in the operating room prior to cesarean section

Chlorhexidine gluconate vaginal scrub and cloth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Angela Bianco: lead
• Stryker Nordic: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (6)

• 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.

  PMID: 27583685 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.

  PMID: 28796683 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.

  PMID: 15695981 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.

  PMID: 20054046 BACKGROUND

• 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.

  PMID: 32580252 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.

  PMID: 32335895 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Results Point of Contact

• Title: Nicola Tavella
• Organization: Icahn School of Medicine at Mount Sinai

nicola.tavella@mssm.edu

212-241-3888

Study Officials

• Angela Bianco, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: October 5, 2018
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2022-02

Locations

US (1)