The Skin Prep Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial|
- Surgical site infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Number of re-admissions and office visits for wound-related problems [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Endometritis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Skin irritation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Allergic reaction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Proportion of patients with skin contamination after skin prep [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Cost savings [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Iodine-alcohol||
Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
Other Name: Prevail-FX, Cardinal Health
Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
Other Name: ChloraPrep, Cardinal Health
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472549
|United States, Missouri|
|St Louis, Missouri, United States, 63108|
|Contact: Methodius G Tuuli, MD, MPH 314-362-4224 email@example.com|
|Principal Investigator: Methodius G Tuuli, MD, MPH|
|Principal Investigator:||Methodius G Tuuli, MD, MPH||Washington University School of Medicine|
|Study Chair:||George Macones, MD, MSCE||Washington University School of Medicine|