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Study on the Reapplication of Chloraprep After Lower Extremity Surgery and Prior to Dressing Application

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ClinicalTrials.gov Identifier: NCT02017145
Recruitment Status : Unknown
Verified February 2014 by Kyle Judd, Sanford Health.
Recruitment status was:  Recruiting
First Posted : December 20, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Kyle Judd, Sanford Health

Brief Summary:
The purpose of the current work is to determine the efficacy of the re-application of surgical prep solution in decreasing surgical site bacterial contamination following lower extremity surgery. Decreasing the extent of bacterial colonization of the skin surrounding the surgical site during the initial healing phases would theoretically decrease the rate of infection in high-risk persons.

Condition or disease Intervention/treatment Phase
Lower Extremity Surgery Surgical Site Infection Bacterial Colonization Surgical Antiseptic Drug: Chloraprep Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
Study Start Date : February 2014
Estimated Primary Completion Date : February 2015


Arm Intervention/treatment
No Intervention: no reapplication
This group will not have chloraprep reapplied after their surgery and prior to dressing application.
Experimental: reapplication
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Drug: Chloraprep



Primary Outcome Measures :
  1. quantitative bacterial colonization [ Time Frame: 14-21 days ]
    Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms

  2. positive culture rate [ Time Frame: 14-21 days ]
    Compare the overall positive culture rate between the two treatment groups


Secondary Outcome Measures :
  1. bacterial strain identification [ Time Frame: 14-21 days ]
    Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female
  • Adults (18+)
  • Both elective and non-elective procedures
  • Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
  • Able to understand and read the English language
  • Signed informed consent

Exclusion Criteria:

  • Pregnant (to be assessed the day of surgery per standard of care surgical protocol)
  • Known allergies to chlorhexidine gluconate or isopropyl alcohol
  • Multiple planned lower extremity surgeries
  • Local skin disease
  • Pre-existing or known infection at surgical site
  • Open wounds or local abrasions
  • Unable to or unwilling to follow through with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02017145


Contacts
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Contact: Jeremy P Morgan, MS 605-328-1398 jeremy.morgan@sanfordhealth.org
Contact: Diane Hahn 605-328-1361 diane.hahn@sanfordhealth.org

Locations
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United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Kyle T Judd, MD    605-328-2663    kyle.judd@sanfordhealth.org   
Principal Investigator: Kyle T Judd, MD         
Sponsors and Collaborators
Sanford Health
Investigators
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Principal Investigator: Kyle T Judd, MD Sanford Orthopedics and Sports Medicine

Publications:
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Responsible Party: Kyle Judd, Employed Physician, Sanford Health
ClinicalTrials.gov Identifier: NCT02017145     History of Changes
Other Study ID Numbers: SH Chloraprep reapplication
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Kyle Judd, Sanford Health:
infection
chloraprep
chlorhexidine
lower extremity surgery
antiseptic
bacterial colonization

Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents