Recruiting

Observational Study

Sponsor:

Sanford Health

Code:

NCT02017145

Conditions

Lower Extremity Surgery

Surgical Site Infection

Bacterial Colonization

Surgical Antiseptic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chloraprep

Study Details

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.

Conditions

Lower Extremity Surgery

Surgical Site Infection

Bacterial Colonization

Surgical Antiseptic

Study ID

NCT02017145

Start date

Feb, 2014

Status verified date

Feb, 2014

Primary completion date

Feb, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Chloraprep

Primary outcome measure

  • quantitative bacterial colonization [ Time Frame: 14-21 days ]
  • positive culture rate [ Time Frame: 14-21 days ]

Central Contacts and Locations

Central contacts

Jeremy P Morgan, MS

605-328-1398jeremy.morgan@sanfordhealth.org

Diane Hahn

605-328-1361diane.hahn@sanfordhealth.org

Locations

Sanford USD Medical Center

Recruiting

Sioux Falls, South Dakota, United States, 57117

Contacts

Kyle T Judd, MD

605-328-2663kyle.judd@sanfordhealth.org

Principal Investigator:

Kyle T Judd, MD

More Information

Sponsor

Sanford Health

Last update posted

Feb 19, 2014

Last verified

Feb, 2014

Keywords

  • infection
  • chloraprep
  • chlorhexidine
  • lower extremity surgery
  • antiseptic
  • bacterial colonization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanford Health on 2014-02-19.