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NCT01233050 · ClinicalTrials.gov registry record · NA
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery
A NA study of Colorectal Surgery, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 802
- Enrollment target
- 3
- Study locations
NCT01233050: Completed NA study of Colorectal Surgery, sponsored by University of Pennsylvania.
NCT01233050 is a NA study of Colorectal Surgery that has completed, run by University of Pennsylvania. The registered enrollment target is 802 participants, above the 230-participant average among 8 other Colorectal Surgery trials with a reported enrollment target (249% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01233050, a NA study of Colorectal Surgery, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 802 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol
- DRUG Iodine Povacrylex/74% Isopropyl Alcohol
Study Locations (3)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- Penn Presbyterian Medical Center - Philadelphia
- Pennsylvania Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2010-12 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT01233050 record still lists
NCT01233050 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, above the 230-participant average among 8 other Colorectal Surgery trials with a reported enrollment target (249% higher).
The record links to 1 condition, with Colorectal Surgery appearing as the primary indexed condition, and to 2 interventions - of which 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol is the first listed.
NCT01233050 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01233050 about?
NCT01233050 is a clinical study titled "Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery". 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. Giv...
What is the current status of trial NCT01233050?
This trial is currently completed. It is a NA study. The enrollment target is 802 participants. The study started on 2010-12. Estimated completion is 2015-02.
What conditions does trial NCT01233050 study?
This clinical trial studies the following conditions: Colorectal Surgery.
What interventions are being tested in trial NCT01233050?
The interventions under investigation include: 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol (DRUG), Iodine Povacrylex/74% Isopropyl Alcohol (DRUG).
Who is sponsoring clinical trial NCT01233050?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01233050 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01233050's enrollment target sits among peer trials
802 1st of 8 higher than 8 of 8 other Colorectal Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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