Total Shoulder ArthroplastyPhase 4NCT07721415
Iodine Drapes Used in TSA
A Phase 4 study testing Total shoulder arthroplasty, Iodine impregnated drapes and Tissue Culture Samples in people with Total Shoulder Arthroplasty and Iodine, run by tnicholson at 1 site in United States.
Trial summary
This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Total Shoulder Arthroplasty, Iodine, Shoulder Surgery
- What is being tested?
- Total shoulder arthroplasty, Iodine impregnated drapes and Tissue Culture Samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Written informed consent
- Elective primary total shoulder arthroplasty
- Male patients
Who cannot join
- Prior surgery on the operative shoulder
- Iodine allergy
- Participation in other clinical trials
- Active infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Effect of Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study
This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery
- Conditions
- Total Shoulder Arthroplasty, Iodine, Shoulder Surgery
- Being tested
- Total shoulder arthroplasty, Iodine impregnated drapes, Tissue Culture Samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total shoulder arthroplastyProcedure or surgery
Participant will have total shoulder arthroplasty surgery
Iodine impregnated drapesDrug
After cleaning the shoulder area in preparation for surgery, the area will be covered and draped using iodine impregnated drapes prior to the start of the participants surgery.
Tissue Culture SamplesProcedure or surgery
One deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Iodine Drapes | Active comparator | When the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine Receives: Procedure: Total shoulder arthroplasty; Drug: Iodine impregnated drapes; Procedure: Tissue Culture Samples |
| Non-iodine drapes | Active comparator | When the participant is in the operating room Surgical draping will be performed using standard cloth drapes Receives: Procedure: Total shoulder arthroplasty; Procedure: Tissue Culture Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture positivity rate
One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start5 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- tnicholson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, tnicholson, Rothman Institute Orthopaedics
- Investigators
- Surena Namdari, MD, Principal investigator, Rothman Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721415
- Sponsor's protocol ID
- SNAM20251199
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iodine Impregnated Drapes on the Rate of Positive Cultures in Primary Total Shoulder Arthroplasty - a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT07721415
- Acronym / sponsor ID
- SNAM20251199
- Conditions
- Total Shoulder Arthroplasty, Iodine, Shoulder Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- tnicholsonUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will directly compare the positive culture rate in shoulder arthroplasty using iodine-impregnated versus non-iodine-impregnated drapes used during surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodine Drapes | Active comparator | Procedure: Total shoulder arthroplasty, Drug: Iodine impregnated drapes, Procedure: Tissue Culture SamplesWhen the participant is in the operating room Surgical draping will be performed using cloth drapes impregnated with iodine |
| Non-iodine drapes | Active comparator | Procedure: Total shoulder arthroplasty, Procedure: Tissue Culture SamplesWhen the participant is in the operating room Surgical draping will be performed using standard cloth drapes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Written informed consent
- Elective primary total shoulder arthroplasty
- Male patients
Key exclusion criteria (4 listed)
- Prior surgery on the operative shoulder
- Iodine allergy
- Participation in other clinical trials
- Active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total shoulder arthroplastyParticipant will have total shoulder arthroplasty surgery | Procedure or surgery | Iodine Drapes, Non-iodine drapes |
| Iodine impregnated drapesAfter cleaning the shoulder area in preparation for surgery, the area will be covered and draped using iodine impregnated drapes prior to the start of the participants surgery. | Drug | Iodine Drapes |
| Tissue Culture SamplesOne deep tissue swab will be taken after final shoulder implant placement and sent for culture to see if bacteria grows after surgery. | Procedure or surgery | Iodine Drapes, Non-iodine drapes |
Primary outcome
Culture positivity rate
Time frame: 13 days
One deep tissue swab will be taken after final implant placement and sent for culture to see if bacteria grows after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Surena Namdari, MD principal investigator
Rothman Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total shoulder arthroplasty, Iodine impregnated drapes and Tissue Culture Samples in people with Total Shoulder Arthroplasty and Iodine, run by tnicholson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture positivity rate (time frame: 13 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.