Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections among Colorectal Surgery Patients (Triple IN Study --Inhibition of Incisional Infections)
ID Number 12-2003Principal Investigator(s)
Joel J Bauer
Department(s) or Division(s)
The purpose of this study is to assess the safety and efficacy of an experimental drug called the E-101 Solution (in addition to routine efforts) in preventing incisional wound infections for 30 days after elective colorectal surgery. An incisional wound infection occurs when bacteria invade the body tissue at the surgical site causing local tissue injury. Wound infections can occur in approximately 12-25% of patients undergoing colorectal surgery despite routine efforts to prevent them. The current standard of care treatment to prevent incisional wound infection includes giving antibiotics during and sometimes after the surgery as a preventative measure, using sterile equipment during the surgery, and having surgeons and nurses wear and use sterile clothing and equipment. Additionally various topical antiseptics are used to clean the skin prior to incision. For colorectal surgery, bowel prep is sometimes used to reduce the number of bacteria in the colon. The purpose of this study is to learn more about the study drug in preventing wound infections within 30 days after colorectal surgery and determine whether it is able to lower wound infection rates in this setting. Patients that qualify for this study are scheduled to have an "open" colon and/or rectal (colorectal) surgery that will result in an anticipated abdominal wall incision of about 3 inches in length or more.
Recruiting Patients: Yes