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Impact of Pre-surgical Nasal Bacterial Reduction on Postoperative Surgical Site Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by 3M.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT01148030
First received: June 18, 2010
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Surgical Site Infection
 Drug: 3M Skin and Nasal Antiseptic
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by 3M:

Primary Outcome Measures:
  • Surgical Site Infection [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 3M Skin and Nasal Antiseptic
    Intra-nasal dosing
  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148030

Contacts
Contact: Raymond Chinn, M.D. (858) 939-3969

Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Raymond Chinn, M.D.     858-292-4211        
Sponsors and Collaborators
3M
  More Information

No publications provided

Responsible Party: Raymond Chinn, M.D., Sharp Memorial Hospital, Infection Prevention Unit
ClinicalTrials.gov Identifier: NCT01148030     History of Changes
Other Study ID Numbers: 11319
Study First Received: June 18, 2010
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013