Surgical Site Infections Clinical Trial
Official title:
Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial
Verified date | July 2018 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators propose a randomized controlled clinical trial to determine the comparative
effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for
preventing surgical site infections at cesarean section. While estimates vary, surgical site
infections complicate up to 5 - 10% of all cesarean sections and result in significant human
suffering and excess health care costs. Interventions such as preoperative antibiotic
prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high.
There is therefore a great need to identify and test other potential interventions to further
reduce these infections.
The skin is a major source of pathogens that cause surgical site infection. Therefore,
optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical
site infections. There is paucity of evidence to guide the choice of antiseptic for skin
preparation at cesarean section. To date, only two underpowered trials have been published
comparing two methods of preoperative skin preparation at cesarean section. A recent
randomized trial in adults undergoing clean-contaminated mostly general surgical procedures
demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol
when compared to the more commonly used povidone-iodine. While it is plausible that findings
from trials in other clean-contaminated surgical procedures may apply to cesarean sections,
physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related
infections and the hormone-mediated immune-modulation in pregnancy make the validity of such
extrapolation uncertain.
The study has the following specific aims:
Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation
at cesarean section significantly reduces surgical site infections compared to
iodine-alcohol.
Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin
preparation at cesarean section significantly reduces bacterial contamination at the surgical
site compared to iodine-alcohol.
Secondary Aim 2: To determine clinical outcomes and medical costs associated with
cesarean-related infections and quantify potential cost savings attributable to use of
chlorhexidine-alcohol for preoperative skin preparation at cesarean section.
Status | Completed |
Enrollment | 1147 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Women undergoing cesarean delivery at Barnes-Jewish Hospital. Exclusion Criteria: - Inability to obtain consent; allergy to chlorhexidine, alcohol, iodine, shellfish; and evidence of infection adjacent to operative site. |
Country | Name | City | State |
---|---|---|---|
United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 30 days | |
Secondary | Length of Hospital Stay | 30 days | ||
Secondary | Number of Participants With Re-admissions or Office Visits for Wound-related Problems | 30 days | ||
Secondary | Number of Participants With Endometritis | 30 days | ||
Secondary | Number of Participants With Skin Irritation | 30 days | ||
Secondary | Number of Participants With Allergic Reaction | 30 days | ||
Secondary | Number of Participants With Skin Contamination After Skin Prep | 1 day | ||
Secondary | Cost Savings | 30 days |
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