Iodine Drapes Used in Total Shoulder Arthroplasty Study
This study is looking at whether using iodine-impregnated drapes during total shoulder arthroplasty (shoulder replacement surgery) can help reduce infections. You might be able to join if you are an adult male, 18 years or older, who is planning to have elective primary total shoulder arthroplasty. You cannot have had previous surgery on that shoulder, an iodine allergy, or an active infection. The study will compare how often bacteria grow in tissue samples taken after surgery when iodine-impregnated drapes are used versus when they are not. The goal is to see if these special drapes can lower the rate of positive cultures (meaning bacteria are found) 13 days after surgery. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 128 adult male participants. It will directly compare the rate of positive cultures in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes.
- What's involved
- You will undergo total shoulder arthroplasty surgery. After cleaning, your shoulder area will be covered with either iodine-impregnated or non-iodine-impregnated drapes. A deep tissue swab will be taken after your shoulder implant is placed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study, culture positivity rate, will be measured 13 days after surgery.
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Iodine Drapes Used in TSA
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Surena Namdari, MD · PRINCIPAL_INVESTIGATOR · Rothman Orthopaedic Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Culture positivity rate13 days
One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.