UnknownPhase 4

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

United States140 participantsStarted 2014-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

quantitative bacterial colonization

Timeframe: 14-21 days

positive culture rate

Timeframe: 14-21 days

Trial details

NCT IDNCT02017145

SponsorSanford Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-02

Contact for this trial

Jeremy P Morgan, MS

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

View on ClinicalTrials.gov More Lower Extremity Surgery trials