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Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

NCT01233050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2018-07-18

Study results available
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Summary

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.

Conditions

  • Colorectal Surgery

Interventions

DRUG

2% Chlorhexidine Gluconate/70% Isopropyl Alcohol

Preoperative skin antisepsis preparation

DRUG

Iodine Povacrylex/74% Isopropyl Alcohol

preoperative skin antisepsis preparation

Sponsors & Collaborators

Principal Investigators

  • Najjia N Mahmoud, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01233050 on ClinicalTrials.gov