Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
* Drug: Iodine Povacrylex/74% Isopropyl Alcohol


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol<br>Preoperative Skin Antisepsis Preparation | Drug: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol<br>* Preoperative skin antisepsis preparation<br>* Other names: ChloraPrep;|
| Active Comparator: Iodine Povacrylex/74% Isopropyl Alcohol<br>Preoperative Skin Antisepsis Preparation | Drug: Iodine Povacrylex/74% Isopropyl Alcohol<br>* preoperative skin antisepsis preparation<br>* Other names: DuraPrep;|

What is the study measuring?
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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. | 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 | 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 |  | within 35 days of randomization to treatment assignment | 
| Number and Percentage of Participants With Deep Wound Infection |  | within 35 days of randomization to treatment assignment | 
| Number and Percentage of Participants With Organ Space Infection |  | within 35 days of randomization to treatment assignment | 
| Length of Hospital Stay |  | within 35 days of randomization to treatment assignment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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undergoing elective colon and /or rectal surgical procedures involving an abdominal incision