Overview

This trial is active, not recruiting.

Condition colorectal surgery
Treatments 2% chlorhexidine gluconate/70% isopropyl alcohol, iodine povacrylex/74% isopropyl alcohol
Sponsor University of Pennsylvania
Collaborator 3M
Start date December 2010
End date February 2015
Trial size 800 participants
Trial identifier NCT01233050, EM-05-012087

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Preoperative Skin Antisepsis Preparation
2% chlorhexidine gluconate/70% isopropyl alcohol ChloraPrep
Preoperative skin antisepsis preparation
(Active Comparator)
Preoperative Skin Antisepsis Preparation
iodine povacrylex/74% isopropyl alcohol DuraPrep
preoperative skin antisepsis preparation

Primary Outcomes

Measure
The primary objective will be measured by the proportion of patients with superficial site infection as defined by the CDC.
time frame: within 35 days of randomization to treatment assignment

Secondary Outcomes

Measure
Time to develop surgical site infection
time frame: within 35 days of randomization to treatment assignment
bacterial pathogens present in documented surgical site infection
time frame: within 35 days of randomization to treatment assignment
proportion and rate of deep wound infections
time frame: within 35 days of randomization to treatment assignment
proportion and rate of organ space infections
time frame: within 35 days of randomization to treatment assignment
length of hospital stay
time frame: within 35 days of randomization to treatment assignment
analysis of inappropriately used antibiotics
time frame: within 35 days of randomization to treatment assignment
cost analysis
time frame: within 35 days of randomization to treatment assignment

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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
Principal investigator Najjia N Mahmoud, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University of Pennsylvania.