Status:
COMPLETED
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
3M
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Eligibility Criteria
Inclusion
- 18 years or older, male or female
- Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
- A clean-contaminated preoperative classification.
- Patient must have decision-making capacity and undergo appropriate informed consent process.
- Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.
Exclusion
- Antibiotics taken within 5 days prior to surgery.
- Infected wound classification.
- Preoperative evaluation that may preclude full closure of the skin.
- Undergoing any bowel procedure that will not result in an extraction incision.
- Ongoing radiation or chemotherapy treatment.
- Pregnant.
- Refusal to accept medically indicated blood products.
- Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
- History of laparotomy within the last 60 days.
- Known allergy to iodine or to chlorhexidine gluconate.
- Participating in a preoperative antibiotic trial.
- Participating in a skin antisepsis trial.
- Participating in Ulcerative colitis trial conflicting with this trial.
- Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
802 Patients enrolled
Trial Details
Trial ID
NCT01233050
Start Date
December 1 2010
End Date
February 1 2015
Last Update
July 18 2018
Active Locations (3)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
3
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19106