Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/20/2018 |
| Start Date: | December 2010 |
| End Date: | February 2015 |
A Randomized Double-Blind Study of 2% Chlorhexidine Gluconate / 70% Isopropyl Alcohol vs Iodine Povacrylex [0.7% Available Iodine] / 74% Isopropyl Alcohol for Perioperative Skin Preparation in Open Elective Colorectal Surgery
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.
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.
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).
We found this trial at
3
sites
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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