Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Not Applicable

Completed

• Conditions: Colorectal Surgery
• Interventions: Drug: Iodine Povacrylex/74% Isopropyl Alcohol; Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

• Registration Number: NCT01233050
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2010-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Results First Submitted: 2017-03-20
• Results First Submitted QC: 2017-08-01
• Results First Posted: 2017-09-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine Povacrylex/74% Isopropyl Alcohol	Iodine Povacrylex/74% Isopropyl Alcohol	Preoperative Skin Antisepsis Preparation
2% Chlorhexidine Gluconate/70% Isopropyl Alcohol	2% Chlorhexidine Gluconate/70% Isopropyl Alcohol	Preoperative Skin Antisepsis Preparation

Primary Outcome Measures

Name	Time	Method
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.	within 35 days of randomization to treatment assignment	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.

Secondary Outcome Measures

Name	Time	Method
Time to Develop Surgical Site Infection	within 35 days of randomization to treatment assignment	average time from surgery to surgical site infection diagnosis
Number and Percentage of Participants With Deep Wound Infection	within 35 days of randomization to treatment assignment
Bacterial Pathogens Present in Documented Surgical Site Infection	within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Organ Space Infection	within 35 days of randomization to treatment assignment
Length of Hospital Stay	within 35 days of randomization to treatment assignment

Trial Locations

Locations (3)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States