Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections

A Randomized Control Trial of Chlorhexidine Gluconate Aqueous Solution vs Chlorhexidine Gluconate With Isopropyl Alcohol Skin Preparations for Prevention of Cesarean Section Wound Infections

This will be a single-center randomized control trial comparing the efficacy of two different formulations of Chlorhexidine surgical skin preparation in preventing cesarean section wound infections. Participants will be randomized to either 4% Chlorhexidine Gluconate aqueous solution (CHG) or 2% Chlorhexidine with isopropyl alcohol (CHG-IPA) 70% to examine the risk of infectious morbidity in those undergoing cesarean delivery. There will also be a cost-effectiveness analysis of the two preoperative skin preparations.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection; Cesarean Section; Infection
• Intervention / Treatment: Drug: 2% Chlorhexidine gluconate with 70% alcohol; Drug: 4% Chlorhexidine Gluconate aqueous solution

• Study Type: Interventional
• Enrollment (Estimated): 1470
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yaneve Fonge, MD; Phone Number: 412-641-6331; Email: Fongeyn@upmc.edu
• Study Contact Backup: Name: Carrie Bennett, MD; Email: bennettcd2@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • University of Pittsburgh
      • Contact: Yaneve N Fonge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women undergoing cesarean delivery at Magee Women's Hospital

Exclusion Criteria:

• Inability to obtain consent (language barrier, emergency cesarean section etc.)
• Allergy to chlorhexidine or alcohol
• Chorioamnionitis
• Emergency cesareans where cannot wait for chlorhexidine alcohol to dry
• bowel injury at time of cesarean section
• Women who are delivered at another institution and are transferred postpartum to Magees Women's Hospital

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep); Including cases undergoing elective &non elective caesarean section. Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min)	Drug: 2% Chlorhexidine gluconate with 70% alcohol; Patients will be prepared similarly using the appropriate number of 26mL Chloraprep sticks for their body surface area. The lever will be pinched to activate the ampoule and release the antiseptic. The solution will be given time to partially load in the sponge. The sponge will be pressed against the skin area where the incision is intended moving back and forth for 30 sec , then working up towards the upper edge of the surgical field and then working from below the incision sight to the upper thighs. The antiseptic will be given time to dry (3 min); Other Names: ChloraPrep
Experimental: 4% chlorhexidine gluconate (Hibiclens); Including cases undergoing elective & nonelective caesarean section. Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.	Drug: 4% Chlorhexidine Gluconate aqueous solution; Patients will be scrubbed preoperative with an applicator that contain 4% chlorohexidine aqueous solution (3 consecutive applications) liberally over 2 minutes followed by drying with sterile towel. The area scrubbed will be the same as the chloraprep group.; Other Names: Hibiclens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Surgical site Infection	Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.	Within 30 days post cesarean

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Endometritis		Within 30 days post cesarean
Number of participants with seroma		Within 30 days post cesarean
Number of Participants With Skin Irritation		within 48 hours from delivery
Number of Participants With Allergic Reaction		within 48 hours from delivery
Number of Participants with intrabdominal/pelvic abscess		Within 90 days post cesarean
Number of Participants with necrotizing fasciitis		Within 90 days post cesarean
Number of Participants with sepsis	With wound/uterine infection as the source	Within 90 days post cesarean
Length of Hospital Stay		Within 90 days post cesarean
Number of Participants With Re-admissions or Office Visits for Wound-related Problems		Within 90 days post cesarean
Number of Participants with ICU admission for wound infectious complications		Within 90 days post cesarean
Number of Participants with Need for wound opening, exploration, or washout in the operating room		Within 90 days post cesarean
Number of Participants who needed wound vacuum		Within 90 days post cesarean
Number of Participants who needed home health		Within 90 days post cesarean
Number of patients who needed antibiotics	will also collect route of antibiotic administration and duration of treatment to assist with cost analysis	Within 90 days post cesarean
Number of doses of antibiotic treatment	for wound infection complications	Within 90 days post cesarean
Antibiotic regimens (medication names) used to treat infection	for wound infection complications	Within 90 days post cesarean
Number of participants with positive culture from wound		Within 90 days post cesarean
The type of bacterial species isolated from wound infection cultures		Within 90 days post cesarean
Number of participants with hematoma		Within 90 days post cesarean
Cost Savings	costs (dollars) associated with a hospital stay, office visits and re-admissions for infection-related complications, ICU admission for infectious complications, wound exploration or washout in the operating room, wound vacuum use, home health, antibiotic prescriptions, and duration of treatment will be collected and used to calculate the cost of wound infection management. The cost difference between groups will be calculated to estimate cost savings.	Within 90 days post cesarean

Collaborators and Investigators

• Sponsor: Yaneve Fonge
• Investigators: Principal Investigator: Yaneve Fonge, MD, University of Pittsburgh

Publications and helpful links

General Publications

• Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7.
• 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.
• Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15.
• Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.
• Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.
• Costantine MM, Rahman M, Ghulmiyah L, Byers BD, Longo M, Wen T, Hankins GD, Saade GR. Timing of perioperative antibiotics for cesarean delivery: a metaanalysis. Am J Obstet Gynecol. 2008 Sep;199(3):301.e1-6. doi: 10.1016/j.ajog.2008.06.077.
• Saeed KB, Greene RA, Corcoran P, O'Neill SM. Incidence of surgical site infection following caesarean section: a systematic review and meta-analysis protocol. BMJ Open. 2017 Jan 11;7(1):e013037. doi: 10.1136/bmjopen-2016-013037.
• Merkow RP, Ju MH, Chung JW, Hall BL, Cohen ME, Williams MV, Tsai TC, Ko CY, Bilimoria KY. Underlying reasons associated with hospital readmission following surgery in the United States. JAMA. 2015 Feb 3;313(5):483-95. doi: 10.1001/jama.2014.18614.
• Ferrannini E, Santoro D, Manicardi V. The association of essential hypertension and diabetes. Compr Ther. 1989 Nov;15(11):51-8.
• Dumville JC, McFarlane E, Edwards P, Lipp A, Holmes A, Liu Z. Preoperative skin antiseptics for preventing surgical wound infections after clean surgery. Cochrane Database Syst Rev. 2015 Apr 21;2015(4):CD003949. doi: 10.1002/14651858.CD003949.pub4.
• Maiwald M, Chan ES. Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis. J Antimicrob Chemother. 2014 Aug;69(8):2017-21. doi: 10.1093/jac/dku121. Epub 2014 Apr 28.
• 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.
• Levin I, Amer-Alshiek J, Avni A, Lessing JB, Satel A, Almog B. Chlorhexidine and alcohol versus povidone-iodine for antisepsis in gynecological surgery. J Womens Health (Larchmt). 2011 Mar;20(3):321-4. doi: 10.1089/jwh.2010.2391. Epub 2011 Feb 16.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: STUDY23030049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No