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AzTrials

Surgical Site InfectionPhase 4NCT05920122

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

A Phase 4 study testing 2% Chlorhexidine gluconate with 70% alcohol and 4% Chlorhexidine Gluconate aqueous solution in people with Surgical Site Infection and Cesarean Section; Infection, run by Hyagriv Simhan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
What is being tested?
2% Chlorhexidine gluconate with 70% alcohol and 4% Chlorhexidine Gluconate aqueous solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,398 participants
Where
1 siteUnited States
Study dates
9 Oct 2023to 17 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women undergoing cesarean delivery at Magee Women's Hospital

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: 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.

Being tested
2% Chlorhexidine gluconate with 70% alcohol, 4% Chlorhexidine Gluconate aqueous solution
Medical subject headings
Surgical Wound Infection, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2% Chlorhexidine gluconate with 70% alcoholDrug

    Also called ChloraPrep

    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)

  • 4% Chlorhexidine Gluconate aqueous solutionDrug

    Also called Hibiclens

    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.

Study groups in NCT05920122
Study groupRoleWhat they receive
2% Chlorhexidine gluconate with 70% alcohol (ChloraPrep)ExperimentalIncluding 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)
Receives: Drug: 2% Chlorhexidine gluconate with 70% alcohol
4% chlorhexidine gluconate (Hibiclens)ExperimentalIncluding 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.
Receives: Drug: 4% Chlorhexidine Gluconate aqueous solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 30 days post cesarean

Secondary outcomes (20)

  1. Number of Participants With Endometritis

    Measured: Within 30 days post cesarean

  2. Number of Participants with intrabdominal/pelvic abscess

    Measured: Within 90 days post cesarean

  3. Number of Participants with necrotizing fasciitis

    Measured: Within 90 days post cesarean

  4. Number of Participants with sepsis

    With wound/uterine infection as the source

    Measured: Within 90 days post cesarean

  5. Length of Hospital Stay

    Measured: Within 90 days post cesarean

  6. Number of Participants With Re-admissions or Office Visits for Wound-related Problems

    Measured: Within 90 days post cesarean

  7. Number of Participants with ICU admission for wound infectious complications

    Measured: Within 90 days post cesarean

  8. Number of Participants with Need for wound opening, exploration, or washout in the operating room

    Measured: Within 90 days post cesarean

  9. Number of Participants who needed wound vacuum

    Measured: Within 90 days post cesarean

  10. Number of Participants who needed home health

    Measured: Within 90 days post cesarean

  11. Number of patients who needed antibiotics

    will also collect route of antibiotic administration and duration of treatment to assist with cost analysis

    Measured: Within 90 days post cesarean

  12. Number of doses of antibiotic treatment

    for wound infection complications

    Measured: Within 90 days post cesarean

  13. Antibiotic regimens (medication names) used to treat infection

    for wound infection complications

    Measured: Within 90 days post cesarean

  14. Number of participants with positive culture from wound

    Measured: Within 90 days post cesarean

  15. The type of bacterial species isolated from wound infection cultures

    Measured: Within 90 days post cesarean

  16. Number of participants with hematoma

    Measured: Within 90 days post cesarean

  17. Number of participants with seroma

    Measured: Within 30 days post cesarean

  18. Number of Participants With Skin Irritation

    Measured: within 48 hours from delivery

  19. Number of Participants With Allergic Reaction

    Measured: within 48 hours from delivery

  20. 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.

    Measured: Within 90 days post cesarean

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start9 Oct 2023
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05920122
Sponsor's protocol ID
STUDY23030049
Status last verified
Jan 2026
First submitted
7 Jun 2023
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18771991

  • 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.

    PubMed 28077411

  • 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.

    PubMed 25647204

  • 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.

    PubMed 28255256

  • 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.

    PubMed 23999949

  • 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.

    PubMed 20054046

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

    PubMed 2684484

  • 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.

    PubMed 28599898

  • 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.

    PubMed 25897764

  • 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.

    PubMed 30118692

  • 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.

    PubMed 24777898

  • 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.

    PubMed 32580252

  • 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.

    PubMed 21323582

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2% Chlorhexidine gluconate with 70% alcohol and 4% Chlorhexidine Gluconate aqueous solution in people with Surgical Site Infection and Cesarean Section; Infection, run by Hyagriv Simhan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Surgical site Infection (time frame: Within 30 days post cesarean). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05920122, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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