A Phase 2 interventional study of 2% chlorhexidine gluconate cloth and 4% Chlorhexidine gluconate vaginal scrub in Cesarean Section, Surgical Site Infection and Nosocomial Infection, sponsored by Angela Bianco. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Angela Bianco · Phase 2, Interventional, and Prevention
Among 201 studies in Surgical Wound Infection with a site in United States — 30 open to participants now, 33 under way, 4 of them phase 3. Surgical Wound Infection · United States.
Among the 201 studies in Surgical Wound Infection with a site in United States, this one is the 68th largest by enrollment of the 176 interventional ones that give a count, is one of 13 that started in 2018, is one of 8 in phase 2, and was the 120th registered.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
Browse Surgical Wound Infection studies →30 of the 201 studies in Surgical Wound Infection with a site in United States are open now. Recruiting first, the newest first:
Montefiore Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Macro Biologics, Inc. · Sites in United States
Ages 18+
Riverside University Health System Medical Center · Sites in United States
Ages 18+ · Women only
University of North Carolina, Chapel Hill · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Rhode Island Hospital · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
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201 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 14 · Phase 3 33 · Phase 4 39
First in 2002; this study’s year is marked. 13 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 319 is above the median of 200 across 581 interventional studies indexed under Surgical Wound Infection.
Median enrollment 211 across the 176 interventional studies, 300 across the 23 observational. Of the 144 that completed or were terminated, 78 (54%) have results posted.
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32 of 201 have an industry lead sponsor. The 10 most frequent:
Angela Bianco is the lead sponsor of 3 studies on the registry; none are open to participants now.
Angela Bianco has 1 study filed under Surgical Wound Infection — fewer than ten, so there is no comparison to draw.
12 of the studies in Surgical Wound Infection with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06014411Hospital for Special Surgery, New YorkEarly Versus Delayed Bathing of Orthopaedic Surgical Wounds | 2026-12 |
| NCT04773457Boston Children's HospitalNeutrophil Phenotypic Profiling and Surgical Site Infections in Surgical Patients | 2026-12-01 |
| NCT04725916Sean DevittStudying How Outpatient Water affEcts Risks With Drains (SHOWER Study) | 2026-12-15 |
| NCT06378359University of MinnesotaEffectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients | 2026-12-31 |
| NCT07379684Macro Biologics, Inc.A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess | 2027-02-28 |
Among the 201 studies in Surgical Wound Infection with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Also known as: 2% Chloraprep solution
applied as a vaginal cleanse in the operating room prior to cesarean section
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.
Time frame: up to 6 weeks postpartum
Number of Participants With Maternal Complications or Interventions
Time frame: up to 6 weeks postpartum
Number of Participants With Neonatal ICU Admissions
Number of participants with newborn with neonatal ICU admissions
Time frame: up to 6 weeks postpartum
Maternal Length of Stay
Time frame: up to 6 weeks postpartum
Number of Participants With Readmissions
Time frame: up to 6 weeks postpartum
Estimated Blood Loss
Time frame: Day 1
Length of Time From Incision to Delivery
Time frame: Day 1
Length of Operation
Time frame: Day 1
Recruitment and enrollment occurred between Oct 2018 and Feb 2021 at Mount Sinai Hospital's Labor and Delivery floor
| Milestone | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Started | 160 | 159 |
| Completed | 152 | 150 |
| Not completed | 8 | 9 |
| Withdrew: Lost to follow-up | 5 | 8 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Withdrawn due to vaginal delivery | 1 | 0 |
| Withdrew: Age < 18 | 1 | 0 |
| Withdrew: No trial of labor | 0 | 1 |
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.
| Participants | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Number of Participants With Surgical Site Infection | 12 | 22 |
| Participants | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Number of Participants With Maternal Complications or Interventions | 7 | 1 |
Number of participants with newborn with neonatal ICU admissions
| Participants | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Number of Participants With Neonatal ICU Admissions | 30 | 36 |
| days | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Maternal Length of Stay | 2.98 ± 1.24 | 2.93 ± 0.78 |
| Participants | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Number of Participants With Readmissions | 6 | 2 |
| mL | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| Estimated Blood Loss | 671 ± 389 | 670 ± 391 |
No measurements were reported for this outcome.
| Participants | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment |
|---|---|---|
| 45-60 minutes | 46 | 46 |
| 61-90 minutes | 87 | 96 |
| 91+ minutes | 27 | 17 |
Collected over up to 6 weeks postpartum. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chlorhexidine Gluconate Vaginal Scrub and Cloth | 0/160 (0%) | 0/160 (0%) | 0/160 (0%) |
| Standard Treatment | 0/159 (0%) | 0/159 (0%) | 0/159 (0%) |
| Age, Continuous(years) | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment | Total |
|---|---|---|---|
| Mean | 32.01 ± 6.10 | 32.59 ± 5.43 | 32.30 ± 5.77 |
| Sex: Female, Male(Participants) | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment | Total |
|---|---|---|---|
| Female | 160 | 159 | 319 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 32 | 30 | 62 |
| Not Hispanic or Latino | 98 | 108 | 206 |
| Unknown or Not Reported | 30 | 21 | 51 |
| Race (NIH/OMB)(Participants) | Chlorhexidine Gluconate Vaginal Scrub and Cloth | Standard Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 15 | 16 | 31 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 25 | 28 | 53 |
| White | 64 | 67 | 131 |
| More than one race | 45 | 35 | 80 |
| Unknown or Not Reported | 11 | 12 | 23 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2018 to primary completion in Feb 2021, 28 months.
Results were first posted in Mar 2023, 2 years 1 month after primary completion. A results delay was requested in Feb 2022.
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This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Angela Bianco