Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery - Full Text View

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:

Drug Information available for: Chlorhexidine Isopropyl alcohol Sodium gluconate Manganese gluconate Iodine Chlorhexidine gluconate Iodide Hibiclens Iodine povacrylex

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	September 2013 (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:

18 years or older, male or female
Undergoing any large bowel procedure with an incision greater than or equal to 7 cm (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.
Incisions less than 7 cm.
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).

Contacts and Locations

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		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

Investigators

Principal Investigator:

Najjia Mahmoud, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Dr. Najjia Mahmoud, MD / Prinicpal 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:	November 1, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

undergoing elective colon and /or rectal surgical procedures involving a laparotomy 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 May 23, 2013