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

NCT05920122 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY23030049
• Study Type: interventional
• Target: 1,398
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Infection; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Number of Participants With Endometritis

  Within 30 days post cesarean

• 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

  Within 90 days post cesarean

• Length of Hospital Stay

  Within 90 days post cesarean

Study Arms (2)

2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)

EXPERIMENTAL

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

4% chlorhexidine gluconate (Hibiclens)

EXPERIMENTAL

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

Interventions

2% Chlorhexidine gluconate with 70% alcohol DRUG

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)

Also known as: ChloraPrep

2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)

4% Chlorhexidine Gluconate aqueous solution DRUG

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.

Also known as: Hibiclens

4% chlorhexidine gluconate (Hibiclens)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing cesarean delivery at Magee Women's Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Hyagriv Simhan: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (13)

• 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.

  PMID: 18771991 BACKGROUND

• 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.

  PMID: 28077411 BACKGROUND

• 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.

  PMID: 25647204 BACKGROUND

• 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.

  PMID: 28255256 BACKGROUND

• 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.

  PMID: 23999949 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

• Ferrannini E, Santoro D, Manicardi V. The association of essential hypertension and diabetes. Compr Ther. 1989 Nov;15(11):51-8.

  PMID: 2684484 BACKGROUND

• 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.

  PMID: 28599898 BACKGROUND

• 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.

  PMID: 25897764 BACKGROUND

• 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.

  PMID: 30118692 BACKGROUND

• 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.

  PMID: 24777898 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 BACKGROUND

• 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.

  PMID: 21323582 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Interventions

chlorhexidine gluconate; Ethanol

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Yaneve Fonge, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The provider making the diagnosis of wound infection will be blinded to the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Immediately prior to entering the operating room, participants will be randomly assigned in a 1:1 ratio to the CHG or CHG-IPA group. Groups will be stratified by laboring status defined as : 1. Regular contractions with cervical dilation of 4 cm or more OR 2. Documented cervical change of at least 1 cm of dilation or at least 50% effacement OR 3. Rupture of membranes

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 27, 2023
• Study Start: October 9, 2023
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)