A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery

Flora Le, Mercer University College of Pharmacy

A review of six trials evaluating the effects of different agents and methods for preoperative skin preparation to prevent post caesarean infections concluded that chlorhexidine gluconate compared with iodine alone was associated with lower rates of bacterial growth at 18 hours after caesarean sections.  However, no difference was found in wound infection, uterine infection, or reduction of skin bacteria colony count. [1]

According to a guideline for the prevention of surgical site infections, chlorhexidine therapy results in a greater reduction of bacterial colony counts than povidone-iodine and triclocarban-medicated soap.  [2]

Title: A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery
Design Single-center, randomized, controlled trial; N= 1147
Objective To evaluate whether the use of chlorhexidine–alcohol for preoperative skin antisepsis was superior to the use of iodine–alcohol for the prevention of surgical-site infection after cesarean delivery
Study Groups Chlorhexidine–alcohol (n= 572); iodine–alcohol (n= 575)
Methods Patients undergoing cesarean delivery were randomly assigned to skin preparations with either chlorhexidine–alcohol or iodine–alcohol in a 1:1 ratio.
Duration September 2011 through June 2015
Primary Outcome Measure Measuring the occurrence of superficial or deep surgical-site infection within 30 days after cesarean delivery
Baseline Characteristics Characteristic Chlorhexidine- Alcohol (n= 572) Iodine- Alcohol

(n= 575)

Maternal age- yr. 28.3 28.4
Gestational age at delivery- weeks 37.6 37.7
Race- no.    
Black 324 312
White 224 238
Other 24 25
BMI 35.1 34.1
Diabetes mellitus- no. 55 65
Prior methicillin resistant Staphylococcus aureus (MRSA) infection- no. 3 1
Pre incision prophylactic antibiotics- no. 567 572
Median duration of surgery- minutes 55 55
Results In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine–alcohol group and in 42 (7.3%) in the iodine–alcohol group (95% [CI]: 0.34 to 0.90).  The rate of superficial surgical-site infection was 3.0% in the chlorhexidine–alcohol group and 4.9% in the iodine–alcohol group (p= 0.10).  The rate of deep infection was 1.0% and 2.4%, respectively (p= 0.07).
Adverse Events Common Adverse Events: erythema at operative site (chlorhexidine- alcohol 2.3%; iodine- alcohol 1.9%); skin irritation (chlorhexidine- alcohol 0%; iodine- alcohol 0.5%); allergic skin reaction (chlorhexidine-alcohol 0.3%; iodine- alcohol 0.2%)
Serious Adverse Events: skin separation (chlorhexidine- alcohol 11.5%; iodine- alcohol 11.5%); seroma (chlorhexidine- alcohol 4.2%; iodine- alcohol 4.9%); hematoma ( chlorhexidine- alcohol 1.2%; iodine- alcohol 0.9%); cellulitis (chlorhexidine- alcohol 0.9%; iodine- alcohol 1.7%)
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions The use of chlorhexidine–alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine–alcohol.

The results from this study are consistent with prior studies and the guideline for the prevention of surgical site infections adapted by the Centers for Disease Control and Prevention (CDC), which suggests the superiority of chlorhexidine-based antiseptics over iodine based antiseptics for the prevention of surgical site infection.  A limitation of this study would be the lack of blinding among the participants and providers, potentially introducing bias.  For future studies, a focus on comparing the superiority of chlorhexidine- based antiseptics with antiseptics other than iodine- alcohol based could be studied to further strengthen the findings in this trial.

References

  1. Hadiati DR, Hakimi M, Nurdiati DS, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2014;9:CD007462.
  2. Berríos-torres SI. Evidence-Based Update to the U.S. Centers for Disease Control and Prevention and Healthcare Infection Control Practices Advisory Committee Guideline for the Prevention of Surgical Site Infection: Developmental Process. Surg Infect (Larchmt). 2016; http://www.cdc.gov/hicpac/pdf/SSIguidelines.pdf.
  3. Tuuli MG, Liu J, Stout MJ, et al. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016;374(7):647-55.

 

 

 

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