Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
Surgical site infections (SSI) are one of the most common complications in the post-operative
patient, and the second most common health care associated infection overall. It is estimated
that there are between 500 thousand and 1.1 million surgical site infections in the United
States each year. Given the magnitude of the problem, prevention of surgical site infections
is a major goal of peri-operative care. However, skin preparation prior to surgery has not
been as rigorously examined. The primary objective of this study is to compare the efficacy
of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate /
70% isopropyl alcohol to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol in
the prevention of superficial surgical site infection. Male and female patients, age 18 years
and older undergoing elective colorectal surgical procedures involving a laparotomy will be
enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at
regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI.
Patients will remain enrolled into the study until 35 days postoperatively.