Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Pennsylvania
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Robyn Broach, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01233050
First received: October 22, 2010
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Colorectal Surgery
Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Drug: Iodine Povacrylex/74% Isopropyl Alcohol

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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The primary objective is to compare 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 proportion of patients with superficial site infection as defined by the CDC.


Secondary Outcome Measures:
  • Time to develop surgical site infection [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • bacterial pathogens present in documented surgical site infection [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • proportion and rate of deep wound infections [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • proportion and rate of organ space infections [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • analysis of inappropriately used antibiotics [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
  • cost analysis [ Time Frame: within 35 days of randomization to treatment assignment ] [ Designated as safety issue: No ]
    treatment of wound infection vs differential cost of preoperative skin preparations


Estimated Enrollment: 800
Study Start Date: October 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ChloraPrep
Preoperative Skin Antisepsis Preparation
Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
Preoperative skin antisepsis preparation
Other Name: ChloraPrep
Active Comparator: DuraPrep
Preoperative Skin Antisepsis Preparation
Drug: Iodine Povacrylex/74% Isopropyl Alcohol
preoperative skin antisepsis preparation
Other Name: DuraPrep

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233050

Contacts
Contact: Robyn Broach, PhD robyn.broach@uphs.upenn.edu
Contact: Najjia Mahmoud, MD 215-662-2078 najjia.mahmoud@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robyn Broach, PhD       robyn.broach@uphs.upenn.edu   
Principal Investigator: Najjia Mahmoud, MD         
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Robyn Broach, PhD       robyn.broach@uphs.upenn.edu   
Sub-Investigator: Robert Fry, MD         
Sub-Investigator: Joshua Bleier, MD         
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Robyn Broach, PhD       robyn.broach@uphs.upenn.edu   
Sub-Investigator: Brian Kann, MD         
Sponsors and Collaborators
University of Pennsylvania
3M
Investigators
Principal Investigator: Najjia N Mahmoud, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Robyn Broach, Sub-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01233050     History of Changes
Other Study ID Numbers: EM-05-012087
Study First Received: October 22, 2010
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
undergoing elective colon and /or rectal surgical procedures involving an abdominal incision

Additional relevant MeSH terms:
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on September 14, 2014