Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Sanford Health
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- quantitative bacterial colonization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
reapplication
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
Intervention: Chloraprep (Drug)
Outcomes
Primary Outcomes
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
positive culture rate
Time Frame: 14-21 days
Compare the overall positive culture rate between the two treatment groups
Secondary Outcomes
- bacterial strain identification(14-21 days)
Investigators
Kyle Judd
Employed Physician
Sanford Health