Back to resultsImpact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change
Primary Purpose
Surgical Site Infection
Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
3M Skin and Nasal Antiseptic
Sponsored by
About this trial
This is an observational trial for Surgical Site Infection
Eligibility Criteria
Inclusion Criteria:
- Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.
Sites / Locations
- Sharp Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Arm Label
Single
Arm Description
3M Skin and Nasal Antiseptic
Outcomes
Primary Outcome Measures
Surgical Site Infection
Secondary Outcome Measures
Full Information
NCT ID
NCT01148030
First Posted
June 18, 2010
Last Updated
February 28, 2014
Sponsor
3M
Collaborators
Sharp HealthCare
1. Study Identification
Unique Protocol Identification Number
NCT01148030
Brief Title
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change
Study Type
Observational
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Outcome measures for pre-intervention were much lower than anticipated.
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
Collaborators
Sharp HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. After surgery, the subjects will be observed for any surgical site infections.
Detailed Description
Infection rate study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
7. Study Design
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Description
3M Skin and Nasal Antiseptic
Intervention Type
Drug
Intervention Name(s)
3M Skin and Nasal Antiseptic
Intervention Description
Intra-nasal dosing
Primary Outcome Measure Information:
Title
Surgical Site Infection
Time Frame
1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting in the Emergency Department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.
Study Population Description
Emergent Hip Fractures
Sampling Method
Probability Sample
Facility Information:
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections / Standard Care Change
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