Randomized Trial of Skin Antiseptics at Cesarean Delivery

Published - Written by MaryAnn Wilbur, M.D. M.P.H.

2-17-2016 9-10-01 AMCesarean section is the most common major abdominal surgery performed in the US and a substantial part of my work as an obstetrician.  So, I was excited about the article just published  in NEJM on skin antisepsis for these procedures.   This article reports a well-executed, randomized controlled trial with a very simple design that included blinding of both the patients and the research assistants reviewing records (the circulating nurse applied the prep; the surgeons may have been able to identify the prep used).  Tuuli et al. randomized 1147 patients undergoing cesarean section to surgical prep with either a chlorhexidine-alcohol solution or an iodine-alcohol solution.  The primary outcome was a superficial or deep wound infection within 30 days, using CDC definitions.  They found that the patients prepped with chlorhexidine were significantly less likely to develop wound infection.  In an intention to treat analysis, rates of superficial and deep surgical site infections in the chlorhexidine and iodine groups were 3.0% versus 4.9% (p=0.10) and 1.1% versus 2.4% (p=0.07), respectively.  Some might question whether such changes are clinically relevant.  I would argue that they are, when considering that cesarean section is such a common procedure.  With over a million women in the US undergoing this procedure each year, cutting even 1% of infections makes a significant difference.

Prior randomized trials have shown that chlorhexidine is superior to iodine-based solutions for surgical preparation, and most general operating rooms are using chlorhexidine as the default skin prep for routine surgical procedures (e.g. appendectomy, cholecystectomy, and oophorectomy).  So, why study this same question in women undergoing cesarean section?  Do we really need to establish this precedent for every individual surgical procedure?  No, I don’t think that we do.  However, there are 2 main reasons why I think this question, specific to cesarean section, is important: (1) because cesarean section is so common and (2) because exposure to vaginal flora, in addition to skin flora, occurs commonly in this surgery.  Establishing the recommended skin prep for cesarean section has large public health implications.  Although many academic hospitals have made the switch to chlorhexidine in labor and delivery units, where most cesarean sections take place, it is not universal.  I have performed cesarean sections at community hospitals still using iodine or betadine scrubs. Thus, the data from this study will likely inform administrative policies for individual institutions and settle this important clinical question.

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