Clinical trial NCT01975805: Chlorhexidine Gluconate Versus Povidone Iodine at Cesarean Delivery: a Randomized Controlled Trial
Official title: To Determine the Difference in Positive Bacterial Cultures in Cesarean Sections With 2% Chlorhexidine- Gluconate, 70% Isopropyl Alcohol (Chloraprep) vs. Povidone-iodine 10% (Betadine) Preoperative Surgical Scrub
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Keywords: cesarean delivery
chlorhexidine
iodine
skin disinfectant
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2013-11-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Currently there are no published studies comparing the efficacy of Chloraprep and povidone-iodine in decreasing postoperative- wound infection in cesarean sections. However, there have been studies involving other types of surgery that have compared the efficacy of different types of preoperative cleansing agents in preventing postoperative wound infection. These studies have shown that controversy exists over which antiseptic skin preparation is the most effective for preventing postoperative surgical wound infections. The standard of care at Los Angeles County Hospital for preoperative skin antiseptic in cesarean sections is povidone- iodine 10% (betadine), however many other hospitals have made the transition to using Chloraprep. In an attempt to improve on the current standard of care, we propose a quality improvement prospective randomized study to compare the difference in postoperative wound complications with the use of povidone- iodine and Chloraprep as a preoperative antiseptic in cesarean sections. We hypothesize that Chloraprep will be better than Betadine at reducing the incidence of positive bacterial cultures following cesarean sections.


Eligibility criteria: Inclusion Criteria:

* Pregnant women greater than 36 weeks gestation presenting for scheduled repeat cesarean sections and scheduled primary cesarean sections
* Ages 18-45
* Written informed consent obtained

Exclusion Criteria:

* Patients who are taking antimicrobial therapy for any reason
* Patient with a known allergy to one or both of the prepping agents
* Patients currently taking immunosuppressant drugs
* Active acute or chronic infection
* Current history of cancer
* Open wounds, skin ulcers, sores, and severe acne
* History of methicillin-resistant staphylococcus aureus colonization or oxacillin-resistant staphylococcus aureus colonization

Primary outcomes:
measure: To compare the difference in the number of positive bacterial cultures at the site of the incision after preoperative cleansing with povidone iodine and Chloraprep.
timeFrame: 3 min-18 days after skin preparation
Secondary outcomes:
measure: To compare the difference in postoperative wound infections measured by the presence of purulent drainage, temp greater than 100.4 F, induration at the site of incision with the use of povidone-iodine and Chloraprep.
timeFrame: Post operative days 0-18
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Cynelle M. Kunkle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Ramen Chmait, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.