The Skin Prep Study

Summary

Cesarean delivery is the most common major surgical procedure in many countries.¹ More women undergo a cesarean section each year in the United States than any other major surgery (over 1 million per year). Cesarean deliveries are associated with a 10-fold increased risk of infection as compared to vaginal delivery² and despite preventive measures, up to one in eight patients (12%) have a surgical-site infection, the most common complication after cesarean section.³ These infections cause patient suffering and even death, increase hospital stays and healthcare costs, and impair women’s abilities to care for their newborns.⁴

Methodius G. Tuuli, MD, MPH, the principal investigator for The Skin Prep Study, and other investigators conducted a randomized, controlled trial (ClinicalTrials.gov#NCT01472549) to compare two common antiseptics for cleansing the skin before cesarean section. The skin is a major source of germs that cause surgical-site infections, so optimal skin cleansing before surgery could reduce infections. However, the best antiseptic to use to cleanse the skin before surgery was unknown. Women who agreed to be part of the study were randomly assigned to be cleansed with either chlorhexidine–alcohol or iodine–alcohol. They were then followed for up to 30 days after surgery to identify those who developed surgical-site infection and other wound complications. Patients cleansed with chlorhexidine-alcohol were less likely than those cleansed with iodine-alcohol to visit their physician’s office for wound complications (7.9% versus 12.5%).

Significance

The investigators concluded that chlorhexidine–alcohol is a better antiseptic than iodine-alcohol for cleansing the skin before cesarean section because it reduces the risk of surgical-site infections. The findings from the study were published in The New England Journal of Medicine in 2016 and ICTS funding UL1 TR000448 was acknowledged in the article.⁵

Benefits

Demonstrated benefits are those that have been observed and are verifiable.

Potential benefits are those logically expected with moderate to high confidence.

The Skin Prep Study is cited in the following guidelines:

• WHO Preoperative Surgical Guidelines, Recommendation 12: Surgical Site Skin Protection
• Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2)
• Preventing Surgical Site Infection After Cesarean Delivery-The Anesthesia Professional’s Role
• Cesarean Section: DynaMed Plus

demonstrated.

Clinical

Guidelines

The use of chlorhexidine-alcohol for preoperative skin antisepsis results in lower risk of surgical-site infections for cesarean deliveries.⁶

demonstrated.

Community

Health care delivery

The use of chlorhexidine-alcohol for preoperative skin antisepsis results in reduced cost of illness related to surgical-site infections.⁷

demonstrated.

Economic

Societal & financial cost of illness

The findings from this study have been observed in three TSBM domains since 2015. The Skin Prep Study has led to the development of several guidelines including a 2016 World Health Organization guideline that cited the study to support recommending chlorhexidine-alcohol as the antiseptic of choice for preoperative skin cleansing for all surgeries.^8,9,10,11

This study was recognized with the 2017 Top Ten Clinical Research Achievement award from the Clinical Research Forum,¹² and has changed clinical practice in the U.S. and beyond. After the investigators presented their work at the 2016 Society for Maternal Fetal Medicine annual meeting and published the study findings⁵ in The New England Journal of Medicine, many hospitals in the U.S. changed their antiseptic for preoperative skin cleansing from iodine-alcohol to chlorhexidine-alcohol. Learn more from this YouTube video.

The Skin Prep Study has the potential to reduce, by half, the number of infections among the over one million women undergoing cesarean sections in the U.S. every year, leading to enhanced delivery of health care.⁶ This would reduce patient suffering, maternal morbidity, length of hospital stays, and healthcare costs.⁶ For example, each surgical-site infection after cesarean section adds an average of 2 days of hospital care and costs approximately $3500 to treat.¹³