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Completed

NCT Number: NCT01233050

Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in 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.

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Key information

Conditions

Colorectal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older, male or female
  • Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
  • A clean-contaminated preoperative classification.
  • Patient must have decision-making capacity and undergo appropriate informed consent process.
  • 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

  • Antibiotics taken within 5 days prior to surgery.
  • Infected wound classification.
  • Preoperative evaluation that may preclude full closure of the skin.
  • Undergoing any bowel procedure that will not result in an extraction incision.
  • Ongoing radiation or chemotherapy treatment.
  • Pregnant.
  • Refusal to accept medically indicated blood products.
  • Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
  • History of laparotomy within the last 60 days.
  • Known allergy to iodine or to chlorhexidine gluconate.
  • Participating in a preoperative antibiotic trial.
  • Participating in a skin antisepsis trial.
  • Participating in Ulcerative colitis trial conflicting with this trial.
  • Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).

Treatment and study plan

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Drug

Preoperative skin antisepsis preparation

Other names: ChloraPrep

Iodine Povacrylex/74% Isopropyl Alcohol

Drug

preoperative skin antisepsis preparation

Other names: DuraPrep

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. Bacterial Pathogens Present in Documented Surgical Site Infection

    Time frame: within 35 days of randomization to treatment assignment

  3. Number and Percentage of Participants With Deep Wound Infection

    Time frame: within 35 days of randomization to treatment assignment

  4. Number and Percentage of Participants With Organ Space Infection

    Time frame: within 35 days of randomization to treatment assignment

  5. Length of Hospital Stay

    Time frame: within 35 days of randomization to treatment assignment

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • 3M

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2010
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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