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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NCT07721415

Iodine Drapes Used in TSA

Enrolling by Invitation
PHASE4Ages 18+InterventionalPrevention
tnicholson
~128 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Total shoulder arthroplastyIodine impregnated drapesTissue Culture Samples

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Culture positivity rate
Measured over 13 days
Total Shoulder Arthroplasty
Iodine
Shoulder Surgery
1 sites across 1 states
Pennsylvania1
  • Surena Namdari, MD · PRINCIPAL_INVESTIGATOR · Rothman Orthopaedic Institute

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Adults ≥ 18 years
Written informed consent
Elective primary total shoulder arthroplasty
Male patients

Exclusion

Prior surgery on the operative shoulder
Iodine allergy
Participation in other clinical trials
Active infection
  • 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.