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

Study Overview
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Brief Summary
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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.

Official Title
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Role of Post-operative Re-application of Chloraprep® Following Lower Extremity Surgeries on Surgical Site Bacterial Colonization.

Conditions
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Lower Extremity Surgery, Surgical Site Infection, Bacterial Colonization, Surgical Antiseptic

Intervention / Treatment
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* Drug: Chloraprep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no reapplication<br>This group will not have chloraprep reapplied after their surgery and prior to dressing application. | |
| Experimental: reapplication<br>This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application. | Drug: Chloraprep<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative bacterial colonization | Compare the number of colony forming units taken from culture swabs immediately adjacent to the wound during dressing change between the two arms | 14-21 days | 
| positive culture rate | Compare the overall positive culture rate between the two treatment groups | 14-21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial strain identification | Assess the total number of bacterial strains and identifying those strains cultured from swabs taken immediately adjacent to the wound during dressing change | 14-21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, chloraprep, chlorhexidine, lower extremity surgery, antiseptic, bacterial colonization