Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Colorectal Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233050
• Other study ID #: EM-05-012087
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: February 2015

Study information

• Verified date: June 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Drug:
• 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Preoperative skin antisepsis preparation
• Iodine Povacrylex/74% Isopropyl Alcohol
preoperative skin antisepsis preparation

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.	The primary objective compares the efficacy of 2% chlorhexidine gluconate / 70% isopropyl alcohol (ChloraPrep) to Iodine Povacrylex [0.7% available Iodine] / 74% Isopropyl Alcohol (DuraPrep) in the prevention of superficial surgical site infection. The primary objective will be measured by the number and percentage of patients with superficial site infection as defined by the CDC.	within 35 days of randomization to treatment assignment
Secondary	Time to Develop Surgical Site Infection	average time from surgery to surgical site infection diagnosis	within 35 days of randomization to treatment assignment
Secondary	Bacterial Pathogens Present in Documented Surgical Site Infection		within 35 days of randomization to treatment assignment
Secondary	Number and Percentage of Participants With Deep Wound Infection		within 35 days of randomization to treatment assignment
Secondary	Number and Percentage of Participants With Organ Space Infection		within 35 days of randomization to treatment assignment
Secondary	Length of Hospital Stay		within 35 days of randomization to treatment assignment