Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Preoperative Skin Antisepsis Preparation

Group Type ACTIVE_COMPARATOR

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Intervention Type DRUG

Preoperative skin antisepsis preparation

Iodine Povacrylex/74% Isopropyl Alcohol

Preoperative Skin Antisepsis Preparation

Group Type ACTIVE_COMPARATOR

Iodine Povacrylex/74% Isopropyl Alcohol

Intervention Type DRUG

preoperative skin antisepsis preparation

Interventions

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2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Preoperative skin antisepsis preparation

Intervention Type DRUG

Iodine Povacrylex/74% Isopropyl Alcohol

preoperative skin antisepsis preparation

Intervention Type DRUG

Other Intervention Names

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ChloraPrep DuraPrep

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes