OHSU

IRB #

IRB00008579

Title

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)

Principal Investigator

Robert Martindale

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of topical E-101 Solution surgical wound applications in the prevention of superficial and deep incisional surgical site infections (SSI) within 30 days after elective colorectal surgery. Specifically, we are looking to see how E-101 Solution compares to placebo in preventing both superficial and deep wound infection when applied to abdominal incisions. We would like to observe these outcomes for 30 days after the date of surgery.

Medical Condition(s)

elective colorectal surgical wound infections

Eligibility Criteria

Scheduled to undergo elective colon and/or rectal surgical procedures involving an open laparotomy incision of 7 cm in length or greater but no more than 35 cm in length. Eligible surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy, ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis, and abdominal perineal resection of the rectum.

Male or female ≥18 years of age.

If female, is non-pregnant (negative pregnancy test result at the Screening/Randomization Visit) and non-lactating.

If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth control and agrees to continue with this regimen over the study surveillance period:

Agreement to be available for evaluation at the study site for scheduled visits.

Age Range

18 - 99

Healthy Volunteers Needed

Yes

Duration of Participation

31 days for most patients. Some patients may be asked to return for repeat lab tests at 3 months and 6 months after surgery. In those cases, subject participation could last up to no more than 6months and one day.

Minors Included

No

Contact

Miriam Douthit 48820

Sponsor

Excited States, LLC

Recruitment End

07/01/2014

Compensation Provided

Yes

Compensation

Subjects will receive $50 for each follow-up visit after their discharge from the hospital starting at the 14 days after discharge. Some patients will be asked to make additional 3 and 6 month visits and could be compensated up to $200 total for their 14 day, 30 day, 3 month and 6 month post-op visit. However, most patients will receive a total of $100 for their 14 day and 30 day post-op visit.


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