Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01233050
Eligibility Criteria:
Inclusion Criteria:
1. 18 years or older, male or female
2. Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
3. A clean-contaminated preoperative classification.
4. Patient must have decision-making capacity and undergo appropriate informed consent process.
5. 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 Criteria:
1. Antibiotics taken within 5 days prior to surgery.
2. Infected wound classification.
3. Preoperative evaluation that may preclude full closure of the skin.
4. Undergoing any bowel procedure that will not result in an extraction incision.
5. Ongoing radiation or chemotherapy treatment.
6. Pregnant.
7. Refusal to accept medically indicated blood products.
8. Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
9. History of laparotomy within the last 60 days.
10. Known allergy to iodine or to chlorhexidine gluconate.
11. Participating in a preoperative antibiotic trial.
12. Participating in a skin antisepsis trial.
13. Participating in Ulcerative colitis trial conflicting with this trial.
14. Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01233050
Study Brief:
Protocol Section:
NCT01233050