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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

October 22, 2010
October 10, 2013
October 2010
September 2014   (final data collection date for primary outcome 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01233050 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Colorectal Surgery
  • Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
    Preoperative skin antisepsis preparation
    Other Name: ChloraPrep
  • Drug: Iodine Povacrylex/74% Isopropyl Alcohol
    preoperative skin antisepsis preparation
    Other Name: DuraPrep
  • Active Comparator: ChloraPrep
    Preoperative Skin Antisepsis Preparation
    Intervention: Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
  • Active Comparator: DuraPrep
    Preoperative Skin Antisepsis Preparation
    Intervention: Drug: Iodine Povacrylex/74% Isopropyl Alcohol
Poulin P, Chapman K, McGahan L, Austen L, Schuler T. Preoperative skin antiseptics for preventing surgical site infections: what to do? ORNAC J. 2014 Sep;32(3):12-5, 24-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
October 2014
September 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
Yes
Contact: Robyn Broach, PhD robyn.broach@uphs.upenn.edu
Contact: Najjia Mahmoud, MD 215-662-2078 najjia.mahmoud@uphs.upenn.edu
United States
 
NCT01233050
EM-05-012087
Yes
Robyn Broach, University of Pennsylvania
University of Pennsylvania
3M
Principal Investigator: Najjia N Mahmoud, MD University of Pennsylvania
University of Pennsylvania
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP