Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

June 21, 2018 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

802

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Preoperative Skin Antisepsis Preparation
Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Preoperative skin antisepsis preparation
Other Names:
  • ChloraPrep
ACTIVE_COMPARATOR: Iodine Povacrylex/74% Isopropyl Alcohol
Preoperative Skin Antisepsis Preparation
Drug: Iodine Povacrylex/74% Isopropyl Alcohol
preoperative skin antisepsis preparation
Other Names:
  • DuraPrep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Objective Measures the Proportion of Patients With Superficial Site Infection as Defined by the CDC.
Time Frame: 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.
within 35 days of randomization to treatment assignment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Develop Surgical Site Infection
Time Frame: within 35 days of randomization to treatment assignment
average time from surgery to surgical site infection diagnosis
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
within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Deep Wound Infection
Time Frame: within 35 days of randomization to treatment assignment
within 35 days of randomization to treatment assignment
Number and Percentage of Participants With Organ Space Infection
Time Frame: within 35 days of randomization to treatment assignment
within 35 days of randomization to treatment assignment
Length of Hospital Stay
Time Frame: within 35 days of randomization to treatment assignment
within 35 days of randomization to treatment assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

3M

Investigators

  • Principal Investigator: Najjia N Mahmoud, MD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

October 22, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (ESTIMATE)

November 2, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-05-012087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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