The Skin Prep Study
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|ClinicalTrials.gov Identifier: NCT01472549|
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infections||Drug: Iodine-alcohol Drug: Chlorhexidine-alcohol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Iodine-alcohol
8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)
Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
Other Name: Prevail-FX, Cardinal Health
2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)
Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
Other Name: ChloraPrep, Cardinal Health
- Number of Participants With Surgical Site Infection [ Time Frame: 30 days ]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.
- Length of Hospital Stay [ Time Frame: 30 days ]
- Number of Participants With Re-admissions or Office Visits for Wound-related Problems [ Time Frame: 30 days ]
- Number of Participants With Endometritis [ Time Frame: 30 days ]
- Number of Participants With Skin Irritation [ Time Frame: 30 days ]
- Number of Participants With Allergic Reaction [ Time Frame: 30 days ]
- Number of Participants With Skin Contamination After Skin Prep [ Time Frame: 1 day ]
- Cost Savings [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472549
|United States, Missouri|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Methodius G Tuuli, MD, MPH||Washington University School of Medicine|
|Study Chair:||George Macones, MD, MSCE||Washington University School of Medicine|