Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT01233050
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2010-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
Sponsor:
University of Pennsylvania
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: