Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Condition(s) targeted: Colorectal Surgery

Intervention: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (Drug); Iodine Povacrylex/74% Isopropyl Alcohol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Najjia Mahmoud, MD, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Robyn Broach, PhD, Email: robyn.broach@uphs.upenn.edu

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: The primary objective will be measured by the proportion of patients with superficial site infection as defined by the CDC.

Secondary outcome:

Time to develop surgical site infection

bacterial pathogens present in documented surgical site infection

proportion and rate of deep wound infections

proportion and rate of organ space infections

length of hospital stay

analysis of inappropriately used antibiotics

cost analysis

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. 18 years or older, male or female

2. Undergoing any large bowel procedure with an incision greater than or equal to 7 cm (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. Incisions less than 7 cm.

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).

Robyn Broach, PhD, Email: robyn.broach@uphs.upenn.edu

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Robyn Broach, PhD, Email: robyn.broach@uphs.upenn.edu
Najjia Mahmoud, MD, Principal Investigator

Pennsylvania Hospital, Philadelphia, Pennsylvania 19106, United States; Recruiting
Robyn Broach, PhD, Email: robyn.broach@uphs.upenn.edu
Robert Fry, MD, Sub-Investigator
Joshua Bleier, MD, Sub-Investigator

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Robyn Broach, PhD, Email: robyn.broach@uphs.upenn.edu
Brian Kann, MD, Sub-Investigator

Starting date: October 2010
Last updated: November 1, 2010